Overview

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.