Overview

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:

Participant gender:

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

Details

Lead Sponsor:

Sanofi

Treatments:

Acarbose
Alogliptin
Aspirin
Metformin