MedTrace Logo

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

NCT02435277 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-01-17

Study results available
· View outcomes & findings →

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.

Conditions

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

Sponsors & Collaborators

  • NuSirt Biopharma

    lead INDUSTRY

Principal Investigators

  • Orville Kolterman, MD · Pharmapace

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-09-30
Completion
2016-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02435277 on ClinicalTrials.gov