An Extension Protocol to Evaluate Dose Comparisons of Leucine-Metformin Combinations in Type 2 Diabetic Patients
Public ClinicalTrials.gov record NCT02435277. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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 identification
- NCT ID
- NCT02435277
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- NuSirt Biopharma
- Industry
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Interventions
- High Metformin Drug
- Low Metformin Drug
- Metformin Drug
- Mid Metformin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2014
- Primary completion
- Aug 31, 2015
- Completion
- Dec 31, 2015
- Last update posted
- Jan 16, 2018
2014 – 2016
United States locations
- U.S. sites
- 9
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Catalina Research Institute | Chino | California | 91710 | — |
| Palm Beach Research | Palm Beach | Florida | 33409 | — |
| Meridien Research | Tampa | Florida | 33606 | — |
| River Birch Research Alliance | Blue Ridge | Georgia | 3051313 | — |
| Meridian Research | Savannah | Georgia | 31406 | — |
| Streling Research Group | Cincinnati | Ohio | 45219 | — |
| Medical Research South | Charleston | South Carolina | 29407 | — |
| Meharry Medical College | Nashville | Tennessee | 37208 | — |
| Vanderbilt University Medical Center, Diabetes, Endocrinology, and Metabolism | Nashville | Tennessee | 37232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02435277, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 16, 2018 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02435277 live on ClinicalTrials.gov.