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

NCT02151461 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2018-02-27

Study results available
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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.

Conditions

Interventions

DRUG

Low Metformin

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

DRUG

Metformin

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

DRUG

Mid Metformin

1100 mg of Leucine in combination with 250 mg Metformin BID

DRUG

High Metformin

1100 mg of Leucine in combination with 500 mg Metformin BID

Sponsors & Collaborators

  • NuSirt Biopharma

    lead INDUSTRY

Principal Investigators

  • Orville G Kolterman, MD · NuSirt Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-08-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT02151461 on ClinicalTrials.gov