Dose Comparisons of Leucine-Metformin Combinations on Blood Glucose Levels In Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Low Metformin; Metformin; Mid Metformin; High Metformin
Intervention description: 1100 mg L Leucine in combination with 125 mg of Metformin BID; 500 mg metformin BID until day 14 with dose escalation at day 14 to 850 mg metformin BID; 1100 mg of Leucine in combination with 250 mg Metformin BID; 1100 mg of Leucine in combination with 500 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: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes; Type 2 Diabetes

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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

          -  Has been treated (within the last month), is currently treated, or is expected to
             require or undergo treatment with; any anti-diabetes medications (other than as
             allowed by the inclusion criteria), oral or parenteral steroids.

          -  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.

          -  Has donated blood within 3 months before Screening or is planning to donate blood
             during the study.

          -  Has known allergies or hypersensitivity to metformin or leucine

          -  Is employed, contracted or has an immediate family member directly affiliated with
             NuSirt Biopharma.