Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 50
Healthy volunteers: no

Brief summary:
Study NS-0100-01E is an extension of Study NS-01-0100 designed to assess safety and longer term effect (i.e., additional 8 weeks) of various fixed-dose leucine and metformin combinations (NS-0100) versus standard metformin monotherapy on glycemic control in subjects with type 2 diabetes using HbA1c as the primary endpoint.

Detailed description:
This is a randomized, 8-week, extension of Study NS-0100-01, to evaluate the effect of various fixed-dose (FDC) combinations of leucine and metformin compared to standard metformin monotherapy on glycemic control.

Subjects meeting all inclusion criteria and no exclusion criteria for the extension study, including completion of the 4-week treatment period of Study NS-0100-01 \[Day 28/Visit 7\]), will be eligible to enroll into the extension. During participation in the extension, subjects will continue to receive their assigned treatment based upon the randomization that occurred on Day 1 (Visit 4) of Study NS-0100-0. The study will include a total of 3 visits: Visit 1E (Day 28/Visit 7 of Study NS-0100-01), Visit 2E (Day 56/Week 8), and Visit 3E (Day 84/Week 12). Key assessments at Visit 2E and Visit 3E include HbA1c, fasting plasma glucose, and plasma insulin. In addition, 3-hour standardized meal tests will be performed on Day 28 (as part of the Study Termination \[Visit 7\] procedures of Study NS-0100-01 prior to enrolling into the extension) and at Study Termination for the extension (Visit 3E \[Day 84/Week 12\]).

Arms:
arm 1: 3 capsules BID with each capsule containing 366.7 mg L-Leucine and 41.7 mg of metformin arm 2: 3 capsules BID with each capsule containing 366.7 mg L-Leucine and 83.3 mg of metformin arm 3: 3 capsules BID with each capsule containing 366.7 mg L-Leucine and 166.7 mg of metformin arm 4: 3 Capsules BID each containing 283.3 mg of metformin BID (1,700 mg/Day) at Day 14.

Interventions: intervention 1: Low Metformin intervention 2: Mid Metformin intervention 3: High Metformin intervention 4: Metformin
Intervention descriptions: intervention 1: 1100 mg L Leucine in combination with 125 mg of Metformin BID intervention 2: 1100 mg L Leucine in combination with 250mg Metformin BID intervention 3: 1100 mg of L Leucine in combination with 500 mg Metformin BID intervention 4: 500 mg Metformin BID until day 14 with dose escalation at day 14 to 850 mg Metformin BID

Protocol document: