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
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.
Timeline
- Start
- 2019-06-29
- Primary completion
- 2020-12-14
- Completion
- 2020-12-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acarbose | Unknown | — | Oral |
| Subject | Alogliptin | Unknown | — | Oral |
| Background | Aspirin | Small molecule | — | Oral |
| Background | Metformin | Small molecule | — | Oral |