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

Sanofi1,293 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,293

Conditions

Type 2 Diabetes Mellitus

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Hemoglobin A1c

Change from baseline in Hemoglobin A1c at the end of study (week 16) between the two drugs

Time frame: Baseline to week 16

Overall Gastrointestinal tolerability

Incidence of any gastrointestinal adverse events during the whole treatment period.

Time frame: Baseline to week 16