NCT02151461View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

August 31, 2015

Study Completion Date

January 31, 2016

Conditions
Type 2 Diabetes Mellitus
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

Trial Locations (9)

29407

Medical Research South, Charleston

30513

River Birch Research Alliance, Blue Ridge

31406

Meridian Research, Savannah

33409

Palm Beach Research, Palm Beach

33606

Meridien Research, Tampa

37208

Meharry Medical College, Nashville

37232

Vanderbilt University Medical Center, Diabetes, Endocrinology, and Metabolism, Nashville

45219

Streling Research Group, Cincinnati

91710

Catalina Research Institute, Chino

Sponsors

Lead Sponsor

NuSirt Biopharma
All Listed Sponsors
lead

NuSirt Biopharma

INDUSTRY