Clinical trial NCT03794336: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-01-07
Enrollment: 1293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Hemoglobin A1c
timeFrame: Baseline to week 16
measure: Overall Gastrointestinal tolerability
timeFrame: Baseline to week 16
Secondary outcomes:
measure: Percentage of patients achieving HbA1c <7%
timeFrame: Baseline to Week 16
measure: Percentage of patients achieving HbA1c <7% without gastrointestinal effects
timeFrame: Baseline to Week 16
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Baseline to Week 16
measure: Occurrence of hypoglycemia events
timeFrame: Baseline to Week 16
measure: Other Adverse Events (AEs)
timeFrame: Baseline to Week 16
measure: Overall tolerability
timeFrame: Baseline to Week 16
measure: Change in Postprandial Plasma Glucose 2-h (PPG)
timeFrame: Baseline to Week 16
measure: Change in Homeostasis model assessment-β (HOMA- β)
timeFrame: Baseline to Week 16
measure: Change in Total Cholesterol (TC)
timeFrame: Baseline to Week 16
measure: Change in Tri Glycerides (TG)
timeFrame: Baseline to Week 16
measure: Change in High Density Lipoprotein-Cholesterol (HDL-C)
timeFrame: Baseline to Week 16
measure: Change in Low Density Lipoprotein-Cholesterol (LDL-C)
timeFrame: Baseline to Week 16
measure: Change in body weight
timeFrame: Baseline to Week 16
measure: Overall adherence to Investigational Medicinal Product (IMP)
timeFrame: Baseline to Week 16
measure: Medication possession ratio (MPR)
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: China
country: China
facility: CHINA
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Gao B, Gao W, Wan H, Xu F, Zhou R, Zhang X, Ji Q. Efficacy and safety of alogliptin versus acarbose in Chinese type 2 diabetes patients with high cardiovascular risk or coronary heart disease treated with aspirin and inadequately controlled with metformin monotherapy or drug-naive: A multicentre, randomized, open-label, prospective study (ACADEMIC). Diabetes Obes Metab. 2022 Jun;24(6):991-999. doi: 10.1111/dom.14661. Epub 2022 Mar 22.