CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 144 enrolled
Drug / intervention
Linagliptin + metformin +1 morecombination
Likely dose
Linagliptin + metformin 850mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03004612
NCT03004612Phase 4Completed

Effect of Linagliptin + Metformin vs Metformin Alone on the Role of Pancreatic Islet Function, Insulin Resistance and Markers of Cardiovascular Risk in Patients With Prediabetes: Randomized Clinical Trial

Universidad de Guanajuato·interventional·Posted Dec 29, 2016·Updated Jul 9, 2019

In Brief

A Phase 4 clinical trial evaluating Linagliptin + metformin and Metformin for Prediabetic State and Insulin Resistance. Completed, enrolled 144 participants across 1 site.

Detailed Summary

Type 2 diabetes is a worldwide epidemic disease, and preventive strategies are needed to face this health problem. The goal of this clinical trial is to evaluate the effect of linagliptin + metformin vs metformin alone on physiopathological parameters, such as glucose metabolism, insulin resistance, insulin secretion and pancreatic beta cell function in patients with impaired fasting glucose plus impaired glucose tolerance, during 24 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 29, 2016
Enrollment StartJan 1, 2016
Primary CompletionMay 1, 2019
Study CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 9.5 years ago

Interventions

Linagliptin + metformincombination

Linagliptin-Metformin 2.5/850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling

Metformindrug

Metformin 850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling