An Extension Protocol to Evaluate Dose Comparisons of Leucine-Metformin Combinations in Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Low Metformin; Mid Metformin; High Metformin; Metformin
Intervention description: 1100 mg L Leucine in combination with 125 mg of Metformin BID; 1100 mg L Leucine in combination with 250mg Metformin BID; 1100 mg of L Leucine in combination with 500 mg Metformin BID; 500 mg Metformin BID until day 14 with dose escalation at day 14 to 850 mg Metformin BID
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes

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.
    

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.