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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435277
Recruitment Status : Completed
First Posted : May 6, 2015
Results First Posted : December 18, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
NuSirt Biopharma

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Low Metformin Drug: Mid Metformin Drug: High Metformin Drug: Metformin Phase 2

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]).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Metformin
3 capsules BID with each capsule containing 366.7 mg L-Leucine and 41.7 mg of metformin
Drug: Low Metformin
1100 mg L Leucine in combination with 125 mg of Metformin BID
Other Name: Metformin, L-Leucince, Leucine

Experimental: Mid Metformin
3 capsules BID with each capsule containing 366.7 mg L-Leucine and 83.3 mg of metformin
Drug: Mid Metformin
1100 mg L Leucine in combination with 250mg Metformin BID
Other Name: Metformin, Leucine, L-Leucine

Experimental: High Metformin
3 capsules BID with each capsule containing 366.7 mg L-Leucine and 166.7 mg of metformin
Drug: High Metformin
1100 mg of L Leucine in combination with 500 mg Metformin BID
Other Name: Metformin, Leucine, L-Leucine

Active Comparator: Metformin Monotherapy
3 Capsules BID each containing 283.3 mg of metformin BID (1,700 mg/Day) at Day 14.
Drug: Metformin
500 mg Metformin BID until day 14 with dose escalation at day 14 to 850 mg Metformin BID
Other Name: Metformin, Leucine, L-Leucine




Primary Outcome Measures :
  1. Change in HbA1c Levels in Patient Receiving the Various Doses of Leucine and Metformin Combinations [ Time Frame: Baseline and 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in Fasting Plasma Glucose [ Time Frame: Baseline and 12 weeks ]
    Change in fasting plasma glucose from Baseline (Day 1/Visit 1) of Study NS-0100-01 to Week 12 (Day 84/Visit 3E). Based on the pre-specified mixed model inferential statistical analysis, there was an apparent dose-dependent relationship for the mean decrease from baseline in fasting plasma glucose for the fixed dose leucine amd metformin combination treatments A, B and C.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435277


Locations
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United States, California
Catalina Research Institute
Chino, California, United States, 91710
United States, Florida
Palm Beach Research
Palm Beach, Florida, United States, 33409
Meridien Research
Tampa, Florida, United States, 33606
United States, Georgia
River Birch Research Alliance
Blue Ridge, Georgia, United States, 3051313
Meridian Research
Savannah, Georgia, United States, 31406
United States, Ohio
Streling Research Group
Cincinnati, Ohio, United States, 45219
United States, South Carolina
Medical Research South
Charleston, South Carolina, United States, 29407
United States, Tennessee
Meharry Medical College
Nashville, Tennessee, United States, 37208
Vanderbilt University Medical Center, Diabetes, Endocrinology, and Metabolism
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
NuSirt Biopharma
Investigators
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Study Chair: Orville Kolterman, MD Pharmapace
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Responsible Party: NuSirt Biopharma
ClinicalTrials.gov Identifier: NCT02435277    
Other Study ID Numbers: NS-0100-01E
First Posted: May 6, 2015    Key Record Dates
Results First Posted: December 18, 2017
Last Update Posted: January 17, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by NuSirt Biopharma:
Diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs