drugset / Trial / NCT02151461

Dose Comparisons of Leucine-Metformin Combinations on Blood Glucose Levels In Type 2 Diabetic Patients

NCT02151461

Phase 2 Completed 96 enrolled NuSirt Biopharma
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2014-07
Primary completion
2015-08
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 125 mg
Subject Metformin Small molecule 250 mg
Subject Metformin Small molecule 500 mg
Subject Metformin Small molecule 850 mg
Subject amino acids Unknown 1100 mg