Type 2 Diabetes
Conditions
Keywords
saxagliptin, glimepiride, metformin monotherapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGSaxagliptin
5 mg/d
DRUGGlimepiride
1mg/d, up titrated 1mg if FPG \>6.1 mmol/L (110mg/dL) till 6 mg
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Zhongda Hospital
Nanjing PLA General Hospital
Changzhou No.2 People's Hospital
The First Affiliated Hospital of Soochow University
Wuxi People's Hospital
The First Affiliated Hospital of Anhui Medical University
Huai'an First People's Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* For inclusion in the study subjects should fulfill the following criteria: * Provision of informed consent prior to any study specific procedures * Type2 diabetic patients had been on stable, maximum tolerated doses of metformin (≧1500mg/d, ≧8 weeks) * Male or female age ≧ 25 years and ≦75 years old * HbA1c ≧7.0 and ≦9.5% * BMI ≧ 20 and ≦ 30 kg/m2
Exclusion criteria
* Subjects should not enter the study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving glycemic response defined as Glycosylated hemoglobin (HbA1c) < 7.0% | Change from Baseline after 48 weeks treatment | 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%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in blood glucose fluctuations of subjects. | Change from Baseline after 48 weeks treatment | 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. |
| The improvement in beta-cell function of subjects | Change from Baseline after 48 weeks treatment | 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. |
| The change in body composition of subjects. | Change from Baseline after 48 weeks treatment | 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. |
| Safety and tolerability of saxagliptin vs. glimepiride measured by adverse events, serious adverse events (SAEs); laboratory assessments (biochemistry, lipids, blood and urine routine tests | Change from Baseline after 48 weeks treatment | 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). |
Countries
China
Outcome results
None listed