Dose Comparisons of Leucine-Metformin Combinations on Blood Glucose Levels In Type 2 Diabetic Patients

NCT02151461 | Completed Phase 2 Results

• 1 other identifier: NS-0100-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 9

Brief Summary

The goal of this study is to demonstrate that leucine in combination with a low does of metformin can serve as an adjunct to diet and exercise to improve blood glucose levels in type 2 diabetic subjects. This study will compare three doses of a leucine-metformin combination to the standard metformin dose in controlling blood glucose levels in type 2 diabetic patients.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Day 28 in Absolute Plasma Glucose Area Under the Curve (AUC) 0-3hr

  The primary endpoint for NS 0100 01 was the absolute plasma glucose AUC (0-3 hr) change from Day 1 to Day 28.

  0, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 2.5hrs and 3 hrs

Secondary Outcomes (7)

• Change From Baseline to Day 28 in Incremental Plasma Glucose Area Under the Curve (AUC)

  Baseline, Day 28

• Change in Fasting Plasma Glucose

  Baseline, Day 28

• Change in Hemoglobin A1c (HbA1c)

  Baseline, Day 28

• Change in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)

  Baseline, Day 28

• Change In 7-Point Glucose Profiles

  Baseline, Day 7, Day 21, Day 28

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

EXPERIMENTAL

3 Capsules BID each containing 166.7 mg of metformin with dose escalation to 283.3 mg capsules 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, Leucine, L-Leucine

Low Metformin

Metformin DRUG

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

Metformin Monotherapy

Mid Metformin DRUG

1100 mg of Leucine in combination with 250 mg Metformin BID

Also known as: Metformin, Leucine, L-Leucine

Mid Metformin

High Metformin DRUG

1100 mg of Leucine in combination with 500 mg Metformin BID

Also known as: Metformin, Leucine, L-Leucine

High Metformin

Eligibility Criteria

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

You may qualify if:

• Over age 18 at study entry.
• Male, or female, 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 and sexually active, must practice and be willing to continue to practice appropriate birth control
• Is diagnosed with type 2 diabetes mellitus and either not adequately controlled by: diet and exercise alone or diet and exercise plus a single, first line treatment for type 2 diabetes.
• If treated with an oral anti-diabetes agent, be willing and able to withdraw from therapy for 4 weeks after the screening visit and prior to initiating study mediation at Baseline (Day 1/Visit 4).
• Be willing to avoid acetaminophen use for intervals up to 10 days as required for study procedures (see Section 4.6)
• Has a fasting plasma glucose ≥126 mg/dL to ≤220 mg/dL at Screening
• Has an HbA1c ≥7% to ≤8.5% at Screening
• Has a BMI ≤40 kg/m2
• Clinical laboratory tests (hematology, clinical chemistry, and urinalysis) either normal or abnormal but consistent with type 2 diabetes mellitus.
• 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:

• Clinically significant renal dysfunction
• If using any of the following medications, has not been on a stable treatment regimen for a minimum of 4 weeks prior to screening:
• Lipid-lowering agents Anti-hypertensive medications Thyroid replacement therapy Non-steroidal anti-inflammatory agents
• Unable to perform self-blood glucose monitoring employing a glucose meter.
• History of active cardio- or cerebro-vascular disease with an event within the previous 6 months
• Gastrointestinal disorders
• Endocrine disorders other than type 2 diabetes
• Chronic infection
• Hepatic disease
• Neurological or psychiatric diseases
• History of other psychiatric disorders
• Participation in a weight loss program within the past 3 months.
• Weight change by more than 10 pounds during the past month.
• History of alcohol or substance abuse in the past 3 months or a positive screen for alcohol or drugs of abuse at screening.
• Has received any investigational drug within 3 months of Screening.

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, 30513, 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

6156567898

Study Officials

• Orville G Kolterman, MD

  NuSirt Biopharma

  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: May 28, 2014
• First Posted: May 30, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 27, 2018
• Results First Posted: February 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)