Clinical trial NCT02435277: An Extension Protocol to Evaluate Dose Comparisons of Leucine-Metformin Combinations in Type 2 Diabetic Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Lead sponsor: NuSirt Biopharma
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[Day 84/Week 12\]).

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.

Primary outcomes:
measure: Change in HbA1c Levels in Patient Receiving the Various Doses of Leucine and Metformin Combinations
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in Fasting Plasma Glucose
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Chino
country: United States
facility: Catalina Research Institute
state: California
city: Palm Beach
country: United States
facility: Palm Beach Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Blue Ridge
country: United States
facility: River Birch Research Alliance
state: Georgia
city: Savannah
country: United States
facility: Meridian Research
state: Georgia
city: Cincinnati
country: United States
facility: Streling Research Group
state: Ohio
city: Charleston
country: United States
facility: Medical Research South
state: South Carolina
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center, Diabetes, Endocrinology, and Metabolism
state: Tennessee
Study officials:
affiliation: Pharmapace
name: Orville Kolterman, MD
role: STUDY_CHAIR
References: