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| Name | Class |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Zhongda Hospital | OTHER |
| Nanjing PLA General Hospital | OTHER |
| Changzhou No.2 People's Hospital |
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This is a multi-centre, open-label, randomized, parallel trial to investigate the efficacy and safety profile of saxagliptin and glimepiride treatment in patients with type 2 diabetes inadequately controlled with metformin monotherapy.
This is a multi-centre, open-label, randomized, parallel trial to investigate the efficacy and safety profile of saxagliptin and glimepiride treatment in patients with type 2 diabetes inadequately controlled with metformin monotherapy.
Screening will be made to select eligible participants before intervention. The trial will include 1-week run-in period of stable doses of metformin (1500mg) and 48-week treatment period. After the run-in period, patients were randomly assigned to one of two groups for antihyperglycaemic therapies for a total of 48-weeks: saxagliptin and glimepiride. The treatment of saxagliptin will be initiated and maintained at 5mg every morning until the completion of the study. Glimepiride will be initially treated with 1 mg every morning, and further titrated up at 4-week intervals until to reach the target fasting blood glucose (FPG).As to Glimepiride groups, if the fasting blood glucose dose not achieved the target after the maximal doses, maintain the maximal doses(6mg per day) until the completion of the study.Meanwhile, participants in both groups should take metformin 1500mg per day throughout the whole 48 weeks. At the end of the study, data will be collected and analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saxagliptin | Active Comparator | The treatment of saxagliptin will be initiated and maintained at 5mg every morning until the completion of the test.Meanwhile,subjects will be instructed to take stable doses of metformin (1500mg/d) through the whole trial. |
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| Glimepiride | Active Comparator | Glimepiride will be initially treated with 1 mg every morning to a dose of 6 mg/day.a.m. Every 4-week the subjects will be evaluated whether reach the target fasting plasma glucose (assayed by finger-stick ≦6.1 mmol/l ). If the fasting blood glucose not achieved the target at the maximum dose, maintain the maximum dose(6mg/d) until the completion of the test.Meanwhile,subjects will be instructed to take stable doses of metformin (1500mg/d) through the whole trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug | 5 mg/d |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving glycemic response defined as Glycosylated hemoglobin (HbA1c) < 7.0% | Compare the proportion of subjects after 48-week treatment achieving HbA1c<7.0%, with no hypoglycemia and no body weight gain (defined as glucose < 3.9 mmol/L with or without symptoms and weight gain < 3.0%). | Change from Baseline after 48 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The change in blood glucose fluctuations of subjects. | 30 subjects of each group would be randomly chosen to evaluate blood glucose fluctuations by continuous glucose monitoring system (CGMS) before and after 48 weeks treatment. | Change from Baseline after 48 weeks treatment |
| The improvement in beta-cell function of subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dalong Zhu, MD, PhD | the Affiliated Drum Tower Hospital of Nanjing University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30520221 | Derived | Gu T, Ma J, Zhang Q, Zhu L, Zhang H, Xu L, Cheng J, Shi B, Li D, Shao J, Sun Z, Zhong S, Bi Y, Zhu D. Comparative effect of saxagliptin and glimepiride with a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in patients uncontrolled with metformin therapy: Results from the SPECIFY study, a 48-week, multi-centre, randomized, controlled trial. Diabetes Obes Metab. 2019 Apr;21(4):939-948. doi: 10.1111/dom.13605. Epub 2019 Jan 4. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C502994 | saxagliptin |
| C057619 | glimepiride |
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| OTHER |
| The First Affiliated Hospital of Soochow University | OTHER |
| Wuxi People's Hospital | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| Huai'an First People's Hospital | OTHER |
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| Glimepiride | Drug | 1mg/d, up titrated 1mg if FPG >6.1 mmol/L (110mg/dL) till 6 mg |
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All subjects would be tested in fasting proinsulin, proinsulin/insulin ratio, true insulin and C-peptide during standard meal test (75-gram instant noodles) before and after 48 weeks treatment. |
| Change from Baseline after 48 weeks treatment |
| The change in body composition of subjects. | All subjects would be measured by their weight (WT), body mass index (BMI) and waist-hip ratio (WHR) every four weeks until the end of 48 weeks treatment. | Change from Baseline after 48 weeks treatment |
| Safety and tolerability of saxagliptin vs. glimepiride measured by adverse events, serious adverse events (SAEs); laboratory assessments (biochemistry, lipids, blood and urine routine tests | The proportion of AEs and SAEs would be measured.Incidence of hypoglycemia episodes (defined as symptoms with glucose < 3.1 mmol/L);adverse events (AEs);serious adverse events (SAEs);laboratory assessments (biochemistry, lipids, blood and urine routine tests);other safety and tolerability parameters (ECG, vital signs, physical examination). | Change from Baseline after 48 weeks treatment |
| D004700 | Endocrine System Diseases |