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
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03794336
- Lead Sponsor
- Sanofi
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1293
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acarbose Aspirin Thrice daily dose of acarbose Dose 1 for 7 days then titrate to thrice daily dose of of acarbose Dose 2 Alogliptin Metformin Single dose of alogliptin once daily for 16 weeks Alogliptin Alogliptin Single dose of alogliptin once daily for 16 weeks Acarbose Acarbose Thrice daily dose of acarbose Dose 1 for 7 days then titrate to thrice daily dose of of acarbose Dose 2 Alogliptin Aspirin Single dose of alogliptin once daily for 16 weeks Acarbose Metformin Thrice daily dose of acarbose Dose 1 for 7 days then titrate to thrice daily dose of of acarbose Dose 2
- Primary Outcome Measures
Name Time Method Overall Gastrointestinal tolerability Baseline to week 16 Incidence of any gastrointestinal adverse events during the whole treatment period.
Change in Hemoglobin A1c Baseline to week 16 Change from baseline in Hemoglobin A1c at the end of study (week 16) between the two drugs
- Secondary Outcome Measures
Name Time Method Percentage of patients achieving HbA1c <7% Baseline to Week 16 Percentage of patients achieving HbA1c \<7% at the end of study
Other Adverse Events (AEs) Baseline to Week 16 Number of patients reporting other Adverse Events
Overall tolerability Baseline to Week 16 Percentage of patients who discontinued study treatment as a result of adverse drug reaction
Change in Postprandial Plasma Glucose 2-h (PPG) Baseline to Week 16 Change in PPG from baseline to week 16 between two groups of drug
Change in High Density Lipoprotein-Cholesterol (HDL-C) Baseline to Week 16 Changes from baseline in HDL-C to week 16 between the two groups
Change in Fasting Plasma Glucose (FPG) Baseline to Week 16 Change in FPG from baseline to week 16 between the two groups of drugs
Occurrence of hypoglycemia events Baseline to Week 16 Number of patients reporting hypoglycemia events
Change in Tri Glycerides (TG) Baseline to Week 16 Changes from baseline in TG to week 16 between the two groups
Change in Low Density Lipoprotein-Cholesterol (LDL-C) Baseline to Week 16 Changes from baseline in LDL-C to week 16 between the two groups.
Change in body weight Baseline to Week 16 Changes from baseline in body weight to week 16 between the two groups
Medication possession ratio (MPR) Baseline to Week 16 Calculated as number of days actually taken IMPs divided by the expected number of days as per protocol
Percentage of patients achieving HbA1c <7% without gastrointestinal effects Baseline to Week 16 Percentage of patients achieving HbA1c \<7% without gastrointestinal effects at the end of study
Change in Homeostasis model assessment-β (HOMA- β) Baseline to Week 16 Change in HOMA- β from baseline to week 16 between two groups of drug
Change in Total Cholesterol (TC) Baseline to Week 16 Changes from baseline in TC to week 16 between the two groups
Overall adherence to Investigational Medicinal Product (IMP) Baseline to Week 16 Calculated as overall dosing actually taken IMPs divided by the expected overall dosing as per protocol
Trial Locations
- Locations (1)
CHINA
🇨🇳China, China