ACADEMIC: 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
Study Details
Study Description
Brief Summary
Primary Objectives:
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To assess efficacy in terms of change from baseline in Hemoglobin A1c (HbA1c) at the end of study between the two drugs.
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To assess tolerability in terms of overall Gastrointestinal (GI) tolerability for Alogliptin compared with acarbose during the whole treatment period.
Secondary Objectives:
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To assess efficacy in terms of the percentage of patients achieving HbA1c<7%.
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To assess efficacy in terms of percentage of patients achieving HbA1c<7% without GI effects.
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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.
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To assess safety in terms of occurrence of hypoglycemia events.
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To assess safety in terms of other adverse events.
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To assess patient adherence and tolerability.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Alogliptin Single dose of alogliptin once daily for 16 weeks |
Drug: Alogliptin
Pharmaceutical form: tablet
Route of administration: oral administration
Other Names:
Drug: Metformin
Pharmaceutical form: tablet
Route of administration: oral administration
Drug: Aspirin
Pharmaceutical form: tablet
Route of administration: oral administration
Other Names:
|
| Active Comparator: Acarbose Thrice daily dose of acarbose Dose 1 for 7 days then titrate to thrice daily dose of of acarbose Dose 2 |
Drug: Acarbose
Pharmaceutical form: tablet
Route of administration: oral administration
Other Names:
Drug: Metformin
Pharmaceutical form: tablet
Route of administration: oral administration
Drug: Aspirin
Pharmaceutical form: tablet
Route of administration: oral administration
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- Overall Gastrointestinal tolerability [Baseline to week 16]
Incidence of any gastrointestinal adverse events during the whole treatment period.
Secondary Outcome Measures
- Percentage of patients achieving HbA1c <7% [Baseline to Week 16]
Percentage of patients achieving HbA1c <7% at the end of study
- 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 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
- 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 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
- Change in Tri Glycerides (TG) [Baseline to Week 16]
Changes from baseline in TG to week 16 between the two groups
- 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 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion criteria :
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Type 2 Diabetes Mellitus patients (age ≥18yr) drug naive or treated with metformin monotherapy (≥1500 mg/day or individually maximally tolerated dose) for at least 12 weeks with a Hemoglobin A1c between ≥ 7.5% and ≤ 11.0% at screening.
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Fasting plasma glucose ≤13.3mmol/L(≤240mg/dL) at screening.
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Patients with documented history of Coronary Heart Disease (CHD) or High cardiovascular(CV) risk.
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History of CHD, defined as previous myocardial infarction or unstable/stable angina.
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High CV risk, defined as male or female (age> 50 yr), combined with at least one of these risk factors as below: family history of cardiovascular disease, history of hypertension, smoking, dyslipidemia, or protein urine.
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Already treated with Aspirin or should start Aspirin treatment at physician's discretion.
Exclusion criteria:
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Diagnosis of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes.
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Previous treatment with any Dipeptidyl Peptidase -4 inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonists within 1 year of screening;
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Any contraindication of Aspirin, Dipeptidyl Peptidase- 4 inhibitor and Alpha-glucosidase inhibitor.
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Clinically apparent liver disease or moderate /severe renal impairment or end-stage renal disease
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Unstable CV disorder including heart failure (New York Heart Association class III or IV), refractory angina, uncontrolled arrhythmias, and severe uncontrolled hypertension (systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥105 mmHg).
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Acute coronary syndrome event within 6 month before randomization
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHINA | China | China |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
- ALOGLC08867
- U1111-1210-0679