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Mechanistic Evaluation of Glucose-lowering Strategies in Patients With Heart Failure

NCT02917031 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2021-11-08

Study results available
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Summary

This is a 24 week, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the effects of saxagliptin and sitagliptin on cardiac dimensions and function in patients with type 2 diabetes (T2DM) mellitus and heart failure (HF).

Conditions

Interventions

DRUG

Saxagliptin

5 mg or 2.5 mg, plain, yellow, biconvex, round, film-coated tablet

DRUG

Sitagliptin

50 mg or 100 mg, gray capsule

DRUG

Placebo to match saxagliptin

2.5 mg or 5 mg, plain, yellow, biconvex, round, film-coated tablet

DRUG

Placebo to match sitagliptin

50 mg or 100 mg, gray capsule

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-10
Primary Completion
2019-08-23
Completion
2019-08-23
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Chile
  • Hungary
  • Romania
  • Russia
  • South Korea
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

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 NCT02917031 on ClinicalTrials.gov