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

• Status: Completed
• Trial end date: 2020-12-14
• Target enrollment: 0
• Participant gender: All

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 Gastrointestinal (GI) tolerability for Alogliptin compared with acarbose during the whole treatment period.

Secondary Objectives:

• To assess efficacy in terms of the percentage of patients achieving HbA1c<7%.

• To assess efficacy in terms of percentage of patients achieving HbA1c<7% without GI effects.

• To assess change from baseline in Fasting plasma glucose (FPG), 2-h Post plasma glucose (2-h PPG), β-cell function (HOMA-β), lipids and body weight.

• To assess safety in terms of occurrence of hypoglycemia events.

• To assess safety in terms of other adverse events.

• To assess patient adherence and tolerability.

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

Details

• Lead Sponsor: Sanofi
• Treatments: Acarbose; Alogliptin; Aspirin; Metformin

Criteria

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.