Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1139-0016 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of liraglutide compared to sitagliptin, both as add-on to metformin in Chinese subjects with type 2 diabetes inadequately controlled on metformin monotherapy. Eligible subjects will continue their metformin background treatment during the trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide 1.8 mg + metformin | Experimental | 2-week screening period, 26-week treatment duration, and a 1-week follow-up period |
|
| Sitagliptin 100 mg + metformin | Active Comparator | 2-week screening period, 26-week treatment duration, and a 1-week follow-up period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | Administered subcutaneously (s.c., under the skin) once daily as add-on to the subject's stable pre-trial metformin dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Haemoglobin (HbA1c) | Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26. | Week 0, week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose | Mean change from baseline in fasting plasma glucose (FPG) at Week 26. | Week 0, week 26 |
| Change From Baseline in 7-point Self-measured Plasma Glucose Profile |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Beijing | Beijing Municipality | 100071 | China | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27060930 | Result | Zang L, Liu Y, Geng J, Luo Y, Bian F, Lv X, Yang J, Liu J, Peng Y, Li Y, Sun Y, Bosch-Traberg H, Mu Y. Efficacy and safety of liraglutide versus sitagliptin, both in combination with metformin, in Chinese patients with type 2 diabetes: a 26-week, open-label, randomized, active comparator clinical trial. Diabetes Obes Metab. 2016 Aug;18(8):803-11. doi: 10.1111/dom.12674. Epub 2016 May 20. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Between screening and randomisation, eligible subjects were to continue their usual pre-trial metformin dose and dosing frequency.
This trial was conducted at 25 sites in China.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Liraglutide | subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks. |
| FG001 | Sitagliptin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| sitagliptin | Drug | Administered orally once daily as add-on to the subject's stable pre-trial metformin dose. |
|
Mean change from baseline in mean of 7-point self-measured plasma glucose at week 26. The 7-point self-measured plasma glucose levels were measured before and after (120 minutes after the start of the meal) the three main meals (breakfast, lunch and dinner), and at bed time.
| Week 0, week 26 |
| Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target) | Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26 | After 26 weeks of treatment |
| Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target) | Calculated as the percentage of subjects achieving treatment target of HbA1c <= 6.5% at Week 26 | After 26 weeks of treatment |
| Number of Confirmed Hypoglycaemic Episodes | confirmed hypoglycaemic episode defined as severe (unable to treat her/himself) or biochemically confirmed by a plasma glucose < 3.1 mmol/L | Weeks 0-26 |
| Beijing |
| Beijing Municipality |
| 100700 |
| China |
| Novo Nordisk Investigational Site | Beijing | Beijing Municipality | 100853 | China |
| Novo Nordisk Investigational Site | Chongqing | Chongqing Municipality | 404000 | China |
| Novo Nordisk Investigational Site | Cangzhou | Hebei | 061000 | China |
| Novo Nordisk Investigational Site | Hengshui | Hebei | 053000 | China |
| Novo Nordisk Investigational Site | Shijiazhuang | Hebei | 050000 | China |
| Novo Nordisk Investigational Site | Shijiazhuang | Hebei | 050051 | China |
| Novo Nordisk Investigational Site | Nanjing | Jiangsu | 210011 | China |
| Novo Nordisk Investigational Site | Nanjing | Jiangsu | 210012 | China |
| Novo Nordisk Investigational Site | Nanjing | Jiangsu | 210029 | China |
| Novo Nordisk Investigational Site | Suzhou | Jiangsu | 215004 | China |
| Novo Nordisk Investigational Site | Wuxi | Jiangsu | 214023 | China |
| Novo Nordisk Investigational Site | Zhenjiang | Jiangsu | 212001 | China |
| Novo Nordisk Investigational Site | Nanchang | Jiangxi | 330006 | China |
| Novo Nordisk Investigational Site | Changchun | Jilin | 130041 | China |
| Novo Nordisk Investigational Site | Dalian | Liaoning | 116033 | China |
| Novo Nordisk Investigational Site | Shenyang | Liaoning | 110021 | China |
| Novo Nordisk Investigational Site | Qingdao | Shandong | 266003 | China |
| Novo Nordisk Investigational Site | Shanghai | Shanghai Municipality | 200080 | China |
| Novo Nordisk Investigational Site | Shanghai | Shanghai Municipality | 200092 | China |
| Novo Nordisk Investigational Site | Shanghai | Shanghai Municipality | 200120 | China |
| Novo Nordisk Investigational Site | Shanghai | Shanghai Municipality | 200240 | China |
| Novo Nordisk Investigational Site | Shanghai | Shanghai Municipality | 201199 | China |
| Novo Nordisk Investigational Site | Beijing | 101200 | China |
orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). |
| Exposed |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Safety analysis set included all subjects receiving at least one dose of investigational product.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Liraglutide | subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks. |
| BG001 | Sitagliptin | orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Body weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Duration of diabetes | Mean | Standard Deviation | years |
| |||||||||||||||
| Fasting plasma glucose (FPG) | Mean | Standard Deviation | mmol/L |
| |||||||||||||||
| Glycosylated haemoglobin A1c (HbA1c) | Mean | Standard Deviation | Percent (%) glycosylated haemoglobin |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Haemoglobin (HbA1c) | Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26. | Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn't have a corresponding post-baseline value. | Posted | Mean | Standard Deviation | Percent (%) glycosylated haemoglobin | Week 0, week 26 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose | Mean change from baseline in fasting plasma glucose (FPG) at Week 26. | Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn't have a corresponding post-baseline value. | Posted | Mean | Standard Deviation | mmol/L | Week 0, week 26 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 7-point Self-measured Plasma Glucose Profile | Mean change from baseline in mean of 7-point self-measured plasma glucose at week 26. The 7-point self-measured plasma glucose levels were measured before and after (120 minutes after the start of the meal) the three main meals (breakfast, lunch and dinner), and at bed time. | Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn't have a corresponding post-baseline value. | Posted | Mean | Standard Deviation | mmol/L | Week 0, week 26 |
|
| |||||||||||||||||||||||||||||
| Secondary | Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target) | Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26 | Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn't have a corresponding post-baseline value. | Posted | Number | percentage of subjects | After 26 weeks of treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target) | Calculated as the percentage of subjects achieving treatment target of HbA1c <= 6.5% at Week 26 | Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn't have a corresponding post-baseline value. | Posted | Number | percentage of subjects | After 26 weeks of treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Confirmed Hypoglycaemic Episodes | confirmed hypoglycaemic episode defined as severe (unable to treat her/himself) or biochemically confirmed by a plasma glucose < 3.1 mmol/L | Safety analysis set included all subjects receiving at least one dose of investigational product. | Posted | Number | episodes | Weeks 0-26 |
|
|
Weeks 0-26
Treatment emergent adverse event defined as an event that had onset date (or increase in severity) on or after the first day of exposure to trial product and no later than seven days after the last day of trial product. Safety analysis set defined as all exposed subjects.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liraglutide | subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks. | 3 | 183 | 65 | 183 | ||
| EG001 | Sitagliptin | orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). | 6 | 184 | 14 | 184 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric ulcer | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Systematic Assessment |
| |
| Thymoma malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 17.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA version 17.1 | Systematic Assessment |
|
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
Not provided
Not provided
| Male |
|
|
| Participants |
|
|
|
|
|