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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 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1293

Last updated 2022-04-25

No results posted yet for this study

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

Interventions

DRUG

Alogliptin

Pharmaceutical form: tablet Route of administration: oral administration

DRUG

Acarbose

Pharmaceutical form: tablet Route of administration: oral administration

DRUG

Metformin

Pharmaceutical form: tablet Route of administration: oral administration

DRUG

Aspirin

Pharmaceutical form: tablet Route of administration: oral administration

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-29
Primary Completion
2020-12-14
Completion
2020-12-14

Countries

  • China

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03794336 on ClinicalTrials.gov