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

NCT03794336 | Completed Phase 4

• 2 other identifiers: ALOGLC08867U1111-1210-0679
• Study Type: interventional
• Target: 1,293
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Change in Hemoglobin A1c

  Change from baseline in Hemoglobin A1c at the end of study (week 16) between the two drugs

  Baseline to week 16

• Overall Gastrointestinal tolerability

  Incidence of any gastrointestinal adverse events during the whole treatment period.

  Baseline to week 16

Secondary Outcomes (15)

• Percentage of patients achieving HbA1c <7%

  Baseline to Week 16

• Percentage of patients achieving HbA1c <7% without gastrointestinal effects

  Baseline to Week 16

• Change in Fasting Plasma Glucose (FPG)

  Baseline to Week 16

• Occurrence of hypoglycemia events

  Baseline to Week 16

• Other Adverse Events (AEs)

  Baseline to Week 16

Study Arms (2)

Alogliptin

EXPERIMENTAL

Single dose of alogliptin once daily for 16 weeks

Drug: Alogliptin; Drug: Metformin; Drug: Aspirin

Acarbose

ACTIVE COMPARATOR

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

Drug: Acarbose; Drug: Metformin; Drug: Aspirin

Interventions

Alogliptin DRUG

Pharmaceutical form: tablet Route of administration: oral administration

Also known as: Nesina

Alogliptin

Acarbose DRUG

Pharmaceutical form: tablet Route of administration: oral administration

Also known as: Glucobay

Acarbose

Metformin DRUG

Pharmaceutical form: tablet Route of administration: oral administration

Acarbose; Alogliptin

Aspirin DRUG

Pharmaceutical form: tablet Route of administration: oral administration

Also known as: Bayaspirin

Acarbose; Alogliptin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

CHINA

China, China

Location

Related Publications (1)

• 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.

  PMID: 35112779 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

alogliptin; Acarbose; Metformin; Aspirin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Biguanides; Guanidines; Amidines; Organic Chemicals; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 7, 2019
• Study Start: June 29, 2019
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)