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

NCT02435277 | Completed Phase 2 Results

• 1 other identifier: NS-0100-01E
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 9

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c Levels in Patient Receiving the Various Doses of Leucine and Metformin Combinations

  Change in HbA1c from Baseline (Day 1/Visit 1) of Study NS-0100-01 to Week 12 (Day 84/Visit 3E) in subjects receiving various fixed-dose combinations of leucine and metformin compared to standard metformin monotherapy.

  Baseline and 12 weeks

Secondary Outcomes (1)

• Change in Fasting Plasma Glucose

  Baseline and 12 weeks

Study Arms (4)

Low Metformin

EXPERIMENTAL

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

Drug: Low Metformin

Mid Metformin

EXPERIMENTAL

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

Drug: Mid Metformin

High Metformin

EXPERIMENTAL

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

Drug: High Metformin

Metformin Monotherapy

ACTIVE COMPARATOR

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

Drug: Metformin

Interventions

Low Metformin DRUG

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

Also known as: Metformin, L-Leucince, Leucine

Low Metformin

Mid Metformin DRUG

1100 mg L Leucine in combination with 250mg Metformin BID

Also known as: Metformin, Leucine, L-Leucine

Mid Metformin

High Metformin DRUG

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

Also known as: Metformin, Leucine, L-Leucine

High Metformin

Metformin DRUG

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

Also known as: Metformin, Leucine, L-Leucine

Metformin Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from the study.
• Is undesirable as a study participant as judged by the investigator (e.g., exhibited poor compliance during Study NS-0100-01)
• 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
• 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.

Sponsors & Collaborators

• NuSirt Biopharma: lead

Study Sites (9)

Catalina Research Institute

Chino, California, 91710, United States

Location

Palm Beach Research

Palm Beach, Florida, 33409, United States

Location

Meridien Research

Tampa, Florida, 33606, United States

Location

River Birch Research Alliance

Blue Ridge, Georgia, 3051313, United States

Location

Meridian Research

Savannah, Georgia, 31406, United States

Location

Streling Research Group

Cincinnati, Ohio, 45219, United States

Location

Medical Research South

Charleston, South Carolina, 29407, United States

Location

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

Vanderbilt University Medical Center, Diabetes, Endocrinology, and Metabolism

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Metformin; Leucine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Results Point of Contact

• Title: Barbara Cannon
• Organization: NuSirt Biopharma

BCannon@nusirt.com

615-656-7898

Study Officials

• Orville Kolterman, MD

  Pharmapace

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: May 6, 2015
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 17, 2018
• Results First Posted: December 18, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)