Type 2 Diabetes Mellitus Clinical Trial
Official title:
An Extension of Protocol NS-0100-01 to Evaluate the Safety and Effect of Various Fixed-Dose Leucine and Metformin Combinations (NS-0100) Versus Standard Metformin Mono-therapy on Glycemic Control in Subjects With Type 2 Diabetes
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.
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]).
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