NCT02435277 - An Extension Protocol to Evaluate Dose Comparisons of Leucine-Metformin Combinations in Type 2 Diabetic Patients | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

September 30, 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

Mid Metformin

1100 mg L Leucine in combination with 250mg Metformin BID

DRUG

High Metformin

1100 mg of L Leucine in combination with 500 mg Metformin BID

DRUG

Metformin

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

Trial Locations (9)

Medical Research South, Charleston

Meridian Research, Savannah

Palm Beach Research, Palm Beach

Meridien Research, Tampa

Meharry Medical College, Nashville

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

Streling Research Group, Cincinnati

Catalina Research Institute, Chino

River Birch Research Alliance, Blue Ridge