Trials / Completed
CompletedNCT03794336
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
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
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,293 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alogliptin | Pharmaceutical form: tablet Route of administration: oral administration |
| DRUG | Acarbose | Pharmaceutical form: tablet Route of administration: oral administration |
| DRUG | Metformin | Pharmaceutical form: tablet Route of administration: oral administration |
| DRUG | Aspirin | Pharmaceutical form: tablet Route of administration: oral administration |
Timeline
- Start date
- 2019-06-29
- Primary completion
- 2020-12-14
- Completion
- 2020-12-14
- First posted
- 2019-01-07
- Last updated
- 2022-04-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03794336. Inclusion in this directory is not an endorsement.