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

• Status: Completed
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Collaborators: Changzhou No.2 People's Hospital; Huai'an First People's Hospital; Huan'an First People's Hospital; Nanjing PLA General Hospital; The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Soochow University; The First Affiliated Hospital with Nanjing Medical University; Wuxi People's Hospital; Zhongda Hospital
• Treatments: Glimepiride; Metformin; Saxagliptin

Criteria

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.