Status:
COMPLETED
Efficacy and Safety of Alogliptin vs. Acarbose in Chinese Type 2 Diabetes Mellitus (T2DM) Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Primary Objectives: * To assess efficacy in terms of change from baseline in Hemoglobin A1c (HbA1c) at the end of study between the two drugs. * To assess tolerability in terms of overall Gastrointes...
Detailed Description
The duration of the study for each patient will be approximately 17 weeks consisting of about 1 week screening period and 16-week treatment period.
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Type 2 Diabetes Mellitus patients (age ≥18yr) drug naive or treated with metformin monotherapy (≥1500 mg/day or individually maximally tolerated dose) for at least 12 weeks with a Hemoglobin A1c between ≥ 7.5% and ≤ 11.0% at screening.
- Fasting plasma glucose ≤13.3mmol/L(≤240mg/dL) at screening.
- Patients with documented history of Coronary Heart Disease (CHD) or High cardiovascular(CV) risk.
- History of CHD, defined as previous myocardial infarction or unstable/stable angina.
- High CV risk, defined as male or female (age\> 50 yr), combined with at least one of these risk factors as below: family history of cardiovascular disease, history of hypertension, smoking, dyslipidemia, or protein urine.
- Already treated with Aspirin or should start Aspirin treatment at physician's discretion.
- Exclusion criteria:
- Diagnosis of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes.
- Previous treatment with any Dipeptidyl Peptidase -4 inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonists within 1 year of screening;
- Any contraindication of Aspirin, Dipeptidyl Peptidase- 4 inhibitor and Alpha-glucosidase inhibitor.
- Clinically apparent liver disease or moderate /severe renal impairment or end-stage renal disease
- Unstable CV disorder including heart failure (New York Heart Association class III or IV), refractory angina, uncontrolled arrhythmias, and severe uncontrolled hypertension (systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥105 mmHg).
- Acute coronary syndrome event within 6 month before randomization
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
June 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2020
Estimated Enrollment :
1293 Patients enrolled
Trial Details
Trial ID
NCT03794336
Start Date
June 29 2019
End Date
December 14 2020
Last Update
April 25 2022
Active Locations (1)
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1
CHINA
China, China