Efficacy and Safety of Saxagliptin VS. Glimepiride in Chinese T2DM Patients Controlled Inadequately With Metformin (SPECIFY)

Nanjing University

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Glimepiride; Drug: Saxagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT02280486

ISSSAXA0014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 388 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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 exclusion criteria are fulfilled:
• Known or suspected allergy to trial products or related products.
• Impaired renal function defined as serum-creatinine ≥ 1.5 mg/dL (≥ 132.6 μmol/l).
• Acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, shock.
• Hepatic insufficiency, acute alcohol intoxication, alcoholism.
• Subjects has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (MI), arrhythmias or conduction delays on ECG, unstable angina, or decompensated heart failure (New York Heart Association-class Ⅲ and Ⅳ).
• Proliferative retinopathy or muscular oedema requiring acute treatment.
• Lactation.
• Pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception (adequate contraceptive measures are sterilization, intrauterine device, oral contraceptives or barrier methods).
• Treatment with systemic corticosteroids within the past two months prior to screening.
• Tested positive for glutamic acid decarboxylase antibody.
• Receipt of any investigational drug within 1 month prior to this trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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388 participants in 2 patient groups

Saxagliptin

Active Comparator group

Description:

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.

Treatment:

Drug: Saxagliptin

Drug: Glimepiride

Glimepiride

Active Comparator group

Description:

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.

Treatment:

Drug: Saxagliptin

Drug: Glimepiride