| Primary | Change in HbA1c | Change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period and 'in trial' observation period. 'On-treatment without rescue medication' observation period: started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. 'In-trial' observation period: started when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation. | Full analysis set comprised of all randomised participants."Number Analyzed" = participants with available data. | Posted | | Mean | Standard Deviation | Percentage of glycosylated haemoglobin | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG002 | Sitagliptin | Participants were randomised to 2 different groups (Group 1: sitagliptin + semaglutide placebo 0.5 mg and Group 2: sitagliptin + semaglutide placebo 1.0 mg). Both groups were pooled together for data analysis. Participants took 100 mg sitagliptin tablets once-daily for 30 weeks. Participants also took semaglutide placebo injection with volume matched to different doses (0.25 mg/0.5 mg/1.0 mg) of semaglutide injection for 30 weeks. Both sitagliptin and semaglutide placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
| | | Title | Denominators | Categories |
|---|
| On-treatment without rescue medication obs. period | - ParticipantsOG000235
- ParticipantsOG001238
- ParticipantsOG002250
| |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. | Mixed Models Analysis | | <.0001 | | Treatment difference | -0.85 | | | 2-Sided | 95 | -1.00 | -0.70 | | | | | Non-Inferiority | Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was less than 0.3%. |
|
| Secondary | Change in Body Weight | Change from baseline (week 0) to week 30 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Mean | Standard Deviation | Kilogram (kg) | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Fasting Plasma Glucose (FPG) | Change from baseline (week 0) to week 30 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed"=participants with available data. | Posted | | Mean | Standard Deviation | Millimoles per liter (mmol/L) | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Self-measured Plasma Glucose (SMPG) - Mean 7-point Profile | Change from baseline (week 0) to week 30 in SMPG mean 7-point profile was evaluated. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Mean | Standard Deviation | Millimoles per liter (mmol/L) | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | |
|
| Secondary | Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals | Change from baseline (week 0) to week 30 in SMPG mean postprandial increment over all meals was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Mean | Standard Deviation | Millimoles per liter (mmol/L) | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Fasting Insulin - Ratio to Baseline | Change in fasting insulin from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting insulin was measured in picomoles per liter (pmol/L). Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fasting insulin | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Fasting C-peptide - Ratio to Baseline | Change in fasting C-peptide from baseline (week 0) to week 30 is presented as ratio to baseline. C-peptide was measured in nanomoles per liter (nmol/L). Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed"=participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fasting C-peptide | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Fasting Glucagon - Ratio to Baseline | Change in fasting glucagon from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting glucagon was measured in picogram per mililiter (pg/mL). Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed"=participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fasting glucagon | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Fasting Proinsulin - Ratio to Baseline | Change in fasting proinsulin from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting proinsulin was measured in picomole per liter (pmol/L). Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed"=participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fasting proinsulin | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Fasting Proinsulin/Insulin Ratio - Ratio to Baseline | Change in fasting proinsulin/insulin ratio from baseline (week 0) to week 30 is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fasting proinsulin/insulin | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Fasting HOMA-B (Beta-cell Function) - Ratio to Baseline | Change in fasting HOMA-B (homeostasis model assessment beta-cell function) from baseline (week 0) to week 30 is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed"=participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fasting HOMA-B | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Fasting HOMA-IR (Insulin Resistence) - Ratio to Baseline | Change in fasting HOMA-IR (homeostasis model assessment insulin resistence) from baseline (week 0) to week 30 is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed"=participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fasting HOMA-IR | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score | Short Form (SF)-36 is a 36-item patient-reported survey that measures patient's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured 8 domains of functional health & well-being and 2 component summary scores (physical component summary-PCS and mental component summary-MCS). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 30. A positive change score indicates an improvement since baseline. Results are based on the data from the 'on-treatment without rescue medication' observation period. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Mean | Standard Deviation | Score on a scale | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Patient Reported Outcome Questionnaire: DTSQs Score | Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire (DTSQs) was evaluated at week 30. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 3 -8. For items 1 and 2 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being "none of the time" unacceptably high (item 1) or low (item 2). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 3-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the 'on-treatment without rescue medication' observation period. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Mean | Standard Deviation | Score on a scale | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in High-sensitivity CRP - Ratio to Baseline | Change in high-sensitivity C-reactive protein (CRP) from baseline (week 0) to week 30 is presented as ratio to baseline. High-sensitivity CRP was measured in mg/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed"=participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of high-sensitivity CRP | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Waist Circumference | Change in waist circumference from baseline (week 0) to week 30 was measured. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Mean | Standard Deviation | Centimeter (cm) | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in BMI | Change in body mass index (BMI) from baseline (week 0) to week 30 was measured. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Mean | Standard Deviation | Kilogram per square meter (kg/m^2) | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Fasting Total Cholesterol - Ratio to Baseline | Change in fasting total cholesterol from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting total cholesterol was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fasting total cholesterol | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Fasting LDL Cholesterol - Ratio to Baseline | Change in fasting low density lipoprotein (LDL) from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting LDL was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fasting LDL cholesterol | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Fasting VLDL Cholesterol - Ratio to Baseline | Change in fasting very low density lipoprotein (VLDL) from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting VLDL was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fasting VLDL cholesterol | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Fasting HDL Cholesterol - Ratio to Baseline | Change in fasting high density lipoprotein (HDL) from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting HDL was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fasting HDL cholesterol | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Fasting Triglycerides - Ratio to Baseline | Change in fasting triglycerides from baseline (week 0) to week 30 is presented as ratio to baseline. Triglycerides was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fasting triglycerides | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Free Fatty Acids - Ratio to Baseline | Change in free fatty acids from baseline (week 0) to week 30 is presented as ratio to baseline. Free fatty acids was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed"=participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of free fatty acids | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Change from baseline (week 0) to week 30 in systolic blood pressure and diastolic blood pressure were evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Mean | Standard Deviation | Millimeters of mercury (mmHg) | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Percentage of Participants Who Achieved HbA1c <7.0% (53 mmol/Mol), ADA Target, (Yes/no) | Percentage of participants who achieved HbA1c < 7.0% (53 millimoles per mole [mmol/mol]), American Diabetes Association (ADA) target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Number | | Percentage of participants | | Week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/Mol), AACE Target, (Yes/no) | Percentage of participants who achieved HbA1c ≤6.5% (48 millimoles per mole [mmol/mol]), American Association of Clinical Endocrinologists (AACE) target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Number | | Percentage of participants | | Week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Percentage of Participants That Achieved (Yes/no): HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia and no Weight Gain | Severe or blood glucose (BG)-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 milligrams per deciliter [mg/dL]) with symptoms consistent with hypoglycaemia. Percentage of participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Number | | Percentage of participants | | Week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 |
|
| Secondary | Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥5% | Percentage of participants losing ≥5% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Number | | Percentage of participants | | Week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥10% | Percentage of participants losing ≥10% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. | Full analysis set comprised of all randomised participants. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Number | | Percentage of participants | | Week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Total Number of Treatment Emergent Adverse Events | A treatment emergent adverse event (TEAE) is defined as an adverse event with onset in the on-treatment observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. | Posted | | Number | | Events | | Week 0 to week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | Hypoglycaemic episodes are defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. | Posted | | Number | | Episodes | | Week 0 to week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Participants With Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | Number of participants with treatment emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes. Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. | Posted | | Count of Participants | | Participants | | Week 0 to week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg |
|
| Secondary | Change in Haematological Parameter: Haemoglobin - Ratio to Baseline | Change in haemoglobin from baseline (week 0) to week 30 is presented as ratio to baseline. Haemoglobin was measured in mmol/L. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of haemoglobin | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Haematological Parameter: Haematocrit - Ratio to Baseline | Change in haematocrit from baseline (week 0) to week 30 is presented as ratio to baseline. Haematocrit was measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of haematocrit | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Hematological Parameter: Thrombocytes - Ratio to Baseline | Change in thrombocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Thrombocytes was measured in 10^9 cells per liter. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of thrombocytes | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Hematological Parameter: Erythrocytes - Ratio to Baseline | Change in erythrocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Erythrocytes were measured in 10^12 cells per liter. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of erythrocytes | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Hematological Parameter: Leukocytes - Ratio to Baseline | Change in leukocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Leukocytes were measured in 10^9 cells per liter. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of leukocytes | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Basophils - Ratio to Baseline | Change in basophils from baseline (week 0) to week 30 is presented as ratio to baseline. Basophils were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of basophils | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Neutrophils - Ratio to Baseline | Change in neutrophils from baseline (week 0) to week 30 is presented as ratio to baseline. Neutrophils were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of neutrophils | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Eosinophils - Ratio to Baseline | Change in eosinophils from baseline (week 0) to week 30 is presented as ratio to baseline. Eosinophils were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of eosinophils | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Monocytes - Ratio to Baseline | Change in monocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Monocytes were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of monocytes | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Hematological Parameter (Differential Cell Count of Leukocytes): Lymphocytes - Ratio to Baseline | Change in lymphocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Lymphocytes were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of lymphocytes | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Biochemistry Parameter: Amylase - Ratio to Baseline | Change in amylase from baseline (week 0) to week 30 is presented as ratio to baseline. Amylase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of amylase | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Biochemistry Parameter: Lipase - Ratio to Baseline | Change in lipase from baseline (week 0) to week 30 is presented as ratio to baseline. Lipase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of lipase | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Biochemistry Parameter: Alkaline Phosphatase - Ratio to Baseline | Change in alkaline phosphatase from baseline (week 0) to week 30 is presented as ratio to baseline. Alkaline phosphatase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of alkaline phosphatase | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Biochemistry Parameter: Alanine Aminotransferase - Ratio to Baseline | Change in alanine aminotransferase from baseline (week 0) to week 30 is presented as ratio to baseline. Alanine aminotransferase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of alanine aminotransferase | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Biochemistry Parameter: Aspartate Aminotransferase - Ratio to Baseline | Change in aspartate aminotransferase from baseline (week 0) to week 30 is presented as ratio to baseline. Aspartate aminotransferase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed "= participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of aspartate aminotransferase | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Biochemistry Parameter: Total Bilirubin - Ratio to Baseline | Change in total bilirubin from baseline (week 0) to week 30 is presented as ratio to baseline. Total bilirubin was measured in micromoles per liter (umol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of total bilirubin | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Biochemistry Parameter: Calcium (Corrected)- Ratio to Baseline | Change in calcium (corrected) from baseline (week 0) to week 30 is presented as ratio to baseline. Calcium was measured in millimoles per litre (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of calcium | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Biochemistry Parameter: Total Calcium - Ratio to Baseline | Change in total calcium from baseline (week 0) to week 30 is presented as ratio to baseline. Calcium was measured in millimoles per litre (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of total calcium | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Biochemistry Parameter: Potassium - Ratio to Baseline | Change in potassium from baseline (week 0) to week 30 is presented as ratio to baseline. Potassium was measured in millimoles per liter (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of potassium | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Biochemistry Parameter: Sodium - Ratio to Baseline | Change in sodium from baseline (week 0) to week 30 is presented as ratio to baseline. Sodium was measured in millimoles per litre (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of sodium | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Biochemistry Parameter: Albumin - Ratio to Baseline | Change in albumin from baseline (week 0) to week 30 is presented as ratio to baseline. Albumin was measured in grams per deciliter (g/dL). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of albumin | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Biochemistry Parameter: Creatine Kinase - Ratio to Baseline | Change in creatine kinase from baseline (week 0) to week 30 is presented as ratio to baseline. Creatine kinase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of creatine kinase | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Biochemistry Parameter: Total Protein- Ratio to Baseline | Change in Total protein from baseline (week 0) to week 30 is presented as ratio to baseline. Total Protein was measured in grams per deciliter (g/dL). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of total protein | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Biochemistry Parameter: Creatinine - Ratio to Baseline | Change in creatinine from baseline (week -2) to week 30 is presented as ratio to baseline. Creatinine was measured in micromoles per lier (umol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of creatinine | | Week -2, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Biochemistry Parameter: Urea - Ratio to Baseline | Change in urea from baseline (week 0) to week 30 is presented as ratio to baseline. Urea was measured in millimoles per liter (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of urea | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Biochemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) - Ratio to Baseline | Change in estimated glomerular filtration rate (eGFR) from baseline (week 0) to week 30 is presented as ratio to baseline. Glomerular filtration rate was measured in milliliter/minute/specific surface area (mL/min/SSA). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of eGFR | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
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| Secondary | Change in Calcitonin - Ratio to Baseline | Change in calcitonin from baseline (week -2) to week 30 is presented as ratio to baseline. Calcitonin was measured in nanogram per liter (ng/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of calcitonin | | Week -2, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Urinalysis Parameter - UACR-ratio to Baseline | Change in urin albumin to creatinine ratio (UACR) from baseline (week 0) to week 30 is presented as ratio to baseline. UACR was measured in milligram/millimole (mg/mmol). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed"=participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of UACR | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
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| Secondary | Change in Urinalysis Parameter: Glucose | Glucose in urine was assessed by the investigator and categorised as negative, [100-249], [250-499], [500-999] and >= 1000. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Count of Participants | | Participants | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Urinalysis Parameter: pH | pH in urine was assessed by the investigator and categorised as 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, >=9. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Count of Participants | | Participants | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Urinalysis Parameter: Protein | Protein in urine was assessed by the investigator and categorised as negative, trace, 30-99, 100-299, Approximately 300, >=300. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Count of Participants | | Participants | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Urinalysis Parameter: Ketones | Ketones in urine was assessed by the investigator and categorised as negative, trace, 15-39, 40-79, Approximately 80, >= 80. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Count of Participants | | Participants | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Urinalysis Parameter: Erythrocytes | Erythrocytes in urine was assessed by the investigator and categorised as negative, trace, small, moderate, large. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Count of Participants | | Participants | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
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| Secondary | Change in Clinical Evaluation: Pulse | Change in pulse from baseline (week 0) to week 30 is presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed"=participants with available data. | Posted | | Mean | Standard Deviation | Beats per minute (beats/min) | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Clinical Evaluation: ECG | The electrocardiogram (ECG) was assessed by the investigator and categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each ECG category at baseline and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Number Analyzed" = participants with available data. | Posted | | Count of Participants | | Participants | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
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| Secondary | Change in Clinical Evaluation: Eye Examinations | Eye examination was performed by the investigator and the results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each category at baseline (week 0) and at week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Number Analyzed" = participants with available data. | Posted | | Count of Participants | | Participants | | Week 0, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Change in Physical Examination | Physical examination parameters are categorised as general appearance; nervous system (central and peripheral); cardiovascular system; gastrointestinal system; skin; respiratory system; lymph node palpation; thyroid gland; left foot; right foot; left leg and right leg. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -2) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Number Analyzed" = participants with available data. | Posted | | Count of Participants | | Participants | | Week -2, week 30 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | |
|
| Secondary | Anti-semaglutide Antibody Levels | This outcome measure is only applicable for the semaglutide arms. Anti-semaglutide antibody level at week 30 and week 35 are presented. Antibody levels were measured in percentage of bound radioactivity-labelled semaglutide/total added radioactivity-labelled semaglutide (%B/T; B =Bound, T = Total). Evaluation was based on 'in trial' observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed"=participants with available data. | Posted | | Mean | Standard Deviation | %B/T | | week 30, week 35 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Occurence of Anti-semaglutide Antibodies (Yes/no) | This outcome measure is only applicable for the semaglutide arms. Development of anti-semaglutide antibodies was evaluated in participants during the study. The number of participants who were positive/ negative for anti-semaglutide antibodies were presented. Evaluation was based on 'in trial' observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Count of Participants | | Participants | | Week 0, week 16, week 30, week 35 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-8 weeks and then 1.0 mg for 9-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. |
|
| Secondary | Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no) | This outcome measure is only applicable for the semaglutide arms. Development of anti-semaglutide antibodies with in-vitro neutralising effect was evaluated in participants during the study. The number of participants who were positive/ negative for anti-semaglutide antibodies with in vitro neutralising effect are presented. Evaluation was based on in-trial observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Count of Participants | | Participants | | Week 0, week 16, week 30, week 35 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | |
|
| Secondary | Occurence of Anti-semaglutide Antibodies Cross Reacting With Endogenous GLP-1 (Yes/no) | This outcome measure is only applicable for the semaglutide arms. Development of anti-semaglutide antibodies cross reacting with endogenous glucagon-like peptide-1 (GLP-1) was evaluated in participants. The number of participants who were positive/ negative for anti-semaglutide antibodies cross reacting with endogenous GLP-1 are presented. Evaluation was based on in-trial observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Count of Participants | | Participants | | Week 35 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | |
|
| Secondary | Occurence of Cross Reacting Antibodies With in Vitro Neutralising Effect to Endogenous GLP-1 (Yes/no) | This outcome measure is only applicable for the semaglutide arms. Development of cross reacting antibodies with in-vitro neutralising effect to endogenous glucagon-like peptide-1 (GLP-1) was evaluated in participants. The number of participants who were positive/ negative for anti-semaglutide antibodies with in vitro neutralising effect to endogenous GLP-1 are presented. Evaluation was based on in-trial observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation. | Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. "Overall Number of Participants Analyzed" = participants with available data. | Posted | | Count of Participants | | Participants | | Week 35 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 0.5 mg | Participants took subcutaneous (s.c., under the skin) injection of semaglutide, once weekly for 30 weeks: 0.25 mg for 0-4 weeks followed by 0.5 mg for 5-30 weeks. Participants also took sitagliptin placebo (0 mg) tablet orally, once daily for 30 weeks. Both semaglutide and sitagliptin placebo were taken any time of the day irrespective of meals. Participants continued taking their pre-trial metformin with the same dose and frequency throughout the trial. | | OG001 | Semaglutide 1.0 mg | |
|