CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Low Metformin +3 moredrug
Likely dose
Low Metformin 1100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02435277
NCT02435277Phase 2Completed
CompareCT.gov

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

NuSirt Biopharma·interventional·Posted May 6, 2015·Updated Jan 17, 2018

In Brief

A Phase 2 clinical trial evaluating Low Metformin, Mid Metformin, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 50 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 6, 2015
Enrollment StartOct 1, 2014
Primary CompletionSep 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.2 years ago

Interventions

Low Metformindrug

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

Mid Metformindrug

1100 mg L Leucine in combination with 250mg Metformin BID

High Metformindrug

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

Metformindrug

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