| Primary | Change From Baseline in HbA1c (Glycosylated Haemoglobin) | Estimated mean change from baseline in HbA1c after 24 weeks of treatment. | Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24. | Posted | | Least Squares Mean | Standard Error | percentage of glycosylated haemoglobin | | Week 0 to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | BID + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment. | | OG001 | BID + Sita + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments. | | OG002 | OD + Sita + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.27± 0.07
- OG001-1.51± 0.07
- OG002-1.15± 0.07
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| | 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 |
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| The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by: H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Met and BID+Sita+Met). | Regression, Linear | | 0.011 | No corrections for multiplicity were performed. | Estimated treatment difference | 0.24 | | | | 95 | 0.06 | 0.43 | | | | No | Superiority or Other | | |
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| Secondary | Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%) | Proportion of subjects achieving HbA1c below 7.0% after 24 weeks of treatment | Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24. | Posted | | Number | | percentage (%) of subjects | | After 24 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | BID + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment. | | OG001 | BID + Sita + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments. | | OG002 |
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| Secondary | Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%) | Proportion of subjects achieving HbA1c equal to or below 6.5% after 24 weeks of treatment. | Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24. | Posted | | Number | | percentage (%) of subjects | | After 24 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | BID + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment. | | OG001 | BID + Sita + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments. | | OG002 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) | Estimated mean change from baseline in fasting plasma glucose (FPG) | Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 556 subjects contributed to the statistical analysis at Week 24. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0 to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | BID + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment. | | OG001 | BID + Sita + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments. | | OG002 | OD + Sita + Met |
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| Secondary | Prandial Plasma Glucose (PPG) Increments at Breakfast | Estimated mean post prandial increments at breakfast after 24 weeks of treatment. | Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 555 subjects contributed to the statistical analysis at Week 24. | Posted | | Least Squares Mean | Standard Error | mmol/L | | After 24 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | BID + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment. | | OG001 | BID + Sita + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments. | | OG002 | OD + Sita + Met |
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| Secondary | Prandial Plasma Glucose (PPG) Increments at Lunch. | Estimated mean post prandial increments at lunch after 24 weeks of treatment. | Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 548 subjects contributed to the statistical analysis at Week 24. | Posted | | Least Squares Mean | Standard Error | mmol/L | | After 24 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | BID + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment. | | OG001 | BID + Sita + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments. | | OG002 | OD + Sita + Met |
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| Secondary | Prandial Plasma Glucose (PPG) Increments at Dinner. | Estimated mean post prandial increments at dinner after 24 weeks of treatment. | Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 550 subjects contributed to the statistical analysis at Week 24. | Posted | | Least Squares Mean | Standard Error | mmol/L | | After 24 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | BID + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment. | | OG001 | BID + Sita + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments. | | OG002 | OD + Sita + Met |
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| Secondary | Prandial Plasma Glucose (PPG) Overall Mean Increment. | Estimated overall mean post prandial increment after 24 weeks of treatment. | Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 557 subjects contributed to the statistical analysis at Week 24. | Posted | | Least Squares Mean | Standard Error | mmol/L | | After 24 weeks of treatment | | | | ID | Title | Description |
|---|
| OG000 | BID + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment. | | OG001 | BID + Sita + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments. | | OG002 | OD + Sita + Met |
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| Secondary | Adverse Events (AEs) | Rate of AEs per 100 years of patient exposure. An adverse event was defined as treatment emergent if the event had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. | Safety analysis set included all subjects receiving at least one dose of the investigational product. | Posted | | Number | | Events/100 years of patient exposure | | Week 0 to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | BID + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment. | | OG001 | BID + Sita + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments. | | OG002 |
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| Secondary | Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes. | Number of treatment emergent hypoglycaemic episodes. Treatment emergent hypoglycaemic episode: if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Nocturnal: Time of onset between 00:01 and 05:59 a.m. (both included). Additional minor hypoglycaemic episode: symptomatic or asymptomatic hypoglycaemia with blood glucose (BG) values < 2.8 mmol/L (50 mg/dL) or plasma glucose (PG) < 3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself. | Safety analysis set included all subjects receiving at least one dose of the investigational product. | Posted | | Number | | episodes | | Week 0 to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | BID + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment. | | OG001 | BID + Sita + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments. |
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| Secondary | Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes. | Estimated mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) 'total score' to end of trial. The score measured treatment satisfaction. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. | Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 545 subjects contributed to the statistical analysis at Week 24. | Posted | | Least Squares Mean | Standard Error | scores | | Week 0 to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | BID + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment. | | OG001 | BID + Sita + Met | Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject's self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments. |
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