Efficacy and Safety of Saxagliptin VS. Glimepiride in Chinese T2DM Patients Controlled Inadequately With Metformin
NCT ID: NCT02280486
Last Updated: 2018-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
388 participants
INTERVENTIONAL
2015-01-31
2017-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Saxagliptin
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.
Saxagliptin
5 mg/d
Glimepiride
1mg/d, up titrated 1mg if FPG \>6.1 mmol/L (110mg/dL) till 6 mg
Glimepiride
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.
Saxagliptin
5 mg/d
Glimepiride
1mg/d, up titrated 1mg if FPG \>6.1 mmol/L (110mg/dL) till 6 mg
Interventions
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Saxagliptin
5 mg/d
Glimepiride
1mg/d, up titrated 1mg if FPG \>6.1 mmol/L (110mg/dL) till 6 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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.
25 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Zhongda Hospital
OTHER
Nanjing PLA General Hospital
OTHER
Changzhou No.2 People's Hospital
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Wuxi People's Hospital
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Huai'an First People's Hospital
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Dalong Zhu
Chief Physician
Principal Investigators
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Dalong Zhu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
the Affiliated Drum Tower Hospital of Nanjing University
Locations
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at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China
Countries
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References
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Gu T, Ma J, Zhang Q, Zhu L, Zhang H, Xu L, Cheng J, Shi B, Li D, Shao J, Sun Z, Zhong S, Bi Y, Zhu D. Comparative effect of saxagliptin and glimepiride with a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in patients uncontrolled with metformin therapy: Results from the SPECIFY study, a 48-week, multi-centre, randomized, controlled trial. Diabetes Obes Metab. 2019 Apr;21(4):939-948. doi: 10.1111/dom.13605. Epub 2019 Jan 4.
Other Identifiers
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ISSSAXA0014
Identifier Type: -
Identifier Source: org_study_id
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