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

NCT ID: NCT03794336

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1293 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-29
• Study Completion Date: 2020-12-14

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alogliptin

Single dose of alogliptin once daily for 16 weeks

Group Type: EXPERIMENTAL

Alogliptin

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral administration

Metformin

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral administration

Aspirin

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral administration

Acarbose

Thrice daily dose of acarbose Dose 1 for 7 days then titrate to thrice daily dose of of acarbose Dose 2

Group Type: ACTIVE_COMPARATOR

Acarbose

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral administration

Metformin

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral administration

Aspirin

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral administration

Interventions

Alogliptin

Pharmaceutical form: tablet

Route of administration: oral administration

Intervention Type: DRUG

Acarbose

Pharmaceutical form: tablet

Route of administration: oral administration

Intervention Type: DRUG

Metformin

Pharmaceutical form: tablet

Route of administration: oral administration

Intervention Type: DRUG

Aspirin

Pharmaceutical form: tablet

Route of administration: oral administration

Intervention Type: DRUG

Other Intervention Names

Nesina; Glucobay; Bayaspirin

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

CHINA

China, , China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 35112779 (View on PubMed)

Other Identifiers

U1111-1210-0679

Identifier Type: OTHER

Identifier Source: secondary_id

ALOGLC08867

Identifier Type: -

Identifier Source: org_study_id