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 — ACADEMIC  

Type 2 Diabetes Mellitus Clinical Trial

Official title: Efficacy and Safety of Alogliptin vs. Acarbose in Chinese T2DM Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive: A Multicenter, Randomized, Open Label, Prospective Study

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT03794336
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 4
• Start date: June 29, 2019
• Completion date: December 14, 2020