CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 96 enrolled
Drug / intervention
Low Metformin +3 moredrug
Likely dose
Low Metformin 1100 mgfrom 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/NCT02151461
NCT02151461Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Active-Controlled Study to Evaluate the Effect of Various Fixed-Dose Leucine and Metformin Combinations (NS-0100) Versus Standard Metformin Monotherapy on Glycemic Control in Subjects With Type 2 Diabetes

NuSirt Biopharma·interventional·Posted May 30, 2014·Updated Feb 27, 2018

In Brief

A Phase 2 clinical trial evaluating Low Metformin, Metformin, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 96 participants across 9 sites.

Detailed Summary

The goal of this study is to demonstrate that leucine in combination with a low does of metformin can serve as an adjunct to diet and exercise to improve blood glucose levels in type 2 diabetic subjects. This study will compare three doses of a leucine-metformin combination to the standard metformin dose in controlling blood glucose levels in type 2 diabetic patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 30, 2014
Enrollment StartJul 1, 2014
Primary CompletionAug 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.1 years ago

Interventions

Low Metformindrug

1100 mg L Leucine in combination with 125 mg of Metformin BID

Metformindrug

500 mg metformin BID until day 14 with dose escalation at day 14 to 850 mg metformin BID

Mid Metformindrug

1100 mg of Leucine in combination with 250 mg Metformin BID

High Metformindrug

1100 mg of Leucine in combination with 500 mg Metformin BID