Status:
COMPLETED
Efficacy and Safety of Saxagliptin VS. Glimepiride in Chinese T2DM Patients Controlled Inadequately With Metformin
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborating Sponsors:
The First Affiliated Hospital with Nanjing Medical University
Zhongda Hospital
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
25-75 years
Phase:
PHASE4
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 con...
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 con...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT02280486
Start Date
January 1 2015
End Date
October 1 2017
Last Update
July 23 2018
Active Locations (1)
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1
at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China, 210008