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

NCT ID: NCT02435277

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-01-31

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]).

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Low Metformin

3 capsules BID with each capsule containing 366.7 mg L-Leucine and 41.7 mg of metformin

Group Type: EXPERIMENTAL

Low Metformin

Intervention Type: DRUG

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

Mid Metformin

3 capsules BID with each capsule containing 366.7 mg L-Leucine and 83.3 mg of metformin

Group Type: EXPERIMENTAL

Mid Metformin

Intervention Type: DRUG

1100 mg L Leucine in combination with 250mg Metformin BID

High Metformin

3 capsules BID with each capsule containing 366.7 mg L-Leucine and 166.7 mg of metformin

Group Type: EXPERIMENTAL

High Metformin

Intervention Type: DRUG

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

Metformin Monotherapy

3 Capsules BID each containing 283.3 mg of metformin BID (1,700 mg/Day) at Day 14.

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

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

Interventions

Low Metformin

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

Intervention Type: DRUG

Mid Metformin

1100 mg L Leucine in combination with 250mg Metformin BID

Intervention Type: DRUG

High Metformin

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

Intervention Type: DRUG

Metformin

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

Intervention Type: DRUG

Other Intervention Names

Metformin, L-Leucince, Leucine; Metformin, Leucine, L-Leucine; Metformin, Leucine, L-Leucine; Metformin, Leucine, L-Leucine

Eligibility Criteria

Inclusion Criteria

1. Has completed Study NS-0100-01, including all procedures required at Study Termination (Day 28/Visit 7) without major protocol deviations

2. Is male, or female and, if female, meets all of the following criteria:

• Not breastfeeding
• Post-menopausal or negative pregnancy test result (human chorionic gonadotropin, beta subunit [β-hCG]) at Screening (Visit 1) (not required for hysterectomized females)
• If of childbearing potential (including perimenopausal women who have had a menstrual period within one year) and sexually active, must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods [male condom with spermicide, with or without cervical cap or diaphragm], implants, injectables, oral contraceptives [must have been using for at least the last 3 months], some intrauterine contraceptive devices, tubal ligation, or a vasectomized partner) during the entire duration of the study.

3. Is able to read, understand, and sign the informed consent forms (ICF) and if applicable, an authorization to use and disclose protected health information form (consistent with health insurance portability and accountability act of 1996 [HIPAA] legislation), communicate with the investigator, and understand and comply with protocol requirements.

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from the study.

1. Is undesirable as a study participant as judged by the investigator (e.g., exhibited poor compliance during Study NS-0100-01)

2. Is expected to require treatment, or if currently on a stable dose, changes to their regimen of the following medications:

• Lipid-lowering agents
• Anti-hypertensive medications
• Thyroid replacement therapy
• Non-steroidal anti-inflammatory agents

3. Is expected to require or undergo treatment with any of the following medications:

• Antidiabetes medications (with the exception of study medication [i.e., metformin])
• Oral or parenteral steroids.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NuSirt Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Orville Kolterman, MD

Role: STUDY_CHAIR

Pharmapace

Locations

Catalina Research Institute

Chino, California, United States

Palm Beach Research

Palm Beach, Florida, United States

Meridien Research

Tampa, Florida, United States

River Birch Research Alliance

Blue Ridge, Georgia, United States

Meridian Research

Savannah, Georgia, United States

Streling Research Group

Cincinnati, Ohio, United States

Medical Research South

Charleston, South Carolina, United States

Meharry Medical College

Nashville, Tennessee, United States

Vanderbilt University Medical Center, Diabetes, Endocrinology, and Metabolism

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

NS-0100-01E

Identifier Type: -

Identifier Source: org_study_id