Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGAlogliptin
Pharmaceutical form: tablet Route of administration: oral administration
DRUGAcarbose
Pharmaceutical form: tablet Route of administration: oral administration
DRUGMetformin
Pharmaceutical form: tablet Route of administration: oral administration
DRUGAspirin
Pharmaceutical form: tablet Route of administration: oral administration
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * 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. * Fasting plasma glucose ≤13.3mmol/L(≤240mg/dL) at screening. * Patients with documented history of Coronary Heart Disease (CHD) or High cardiovascular(CV) risk. * History of CHD, defined as previous myocardial infarction or unstable/stable angina. * 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. * Already treated with Aspirin or should start Aspirin treatment at physician's discretion.
Exclusion criteria
* Diagnosis of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes. * Previous treatment with any Dipeptidyl Peptidase -4 inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonists within 1 year of screening; * Any contraindication of Aspirin, Dipeptidyl Peptidase- 4 inhibitor and Alpha-glucosidase inhibitor. * Clinically apparent liver disease or moderate /severe renal impairment or end-stage renal disease * 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). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Percentage of patients achieving HbA1c <7% | Baseline to Week 16 | Percentage of patients achieving HbA1c \<7% at the end of study |
| 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 |
| Change in Total Cholesterol (TC) | Baseline to Week 16 | Changes from baseline in TC to week 16 between the two groups |
| 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 |
Countries
China
Outcome results
None listed