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

Type 2 Diabetes Mellitus research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Type 2 Diabetes Mellitus

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Low Metformin1100 mg L Leucine in combination with 125 mg of Metformin BID

Drug:Metformin500 mg metformin BID until day 14 with dose escalation at day 14 to 850 mg metformin BID

Drug:Mid Metformin1100 mg of Leucine in combination with 250 mg Metformin BID

Drug:High Metformin1100 mg of Leucine in combination with 500 mg Metformin BID

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Low Metformin3 capsules BID with each capsule containing 366.7 mg L-Leucine and 41.7 mg of metformin

Mid Metformin3 capsules BID with each capsule containing 366.7 mg L-Leucine and 83.3 mg of metformin

High Metformin3 capsules BID with each capsule containing 366.7 mg L-Leucine and 166.7 mg of metformin

Metformin Monotherapy3 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.

Study Status

Completed

Start Date: July 2014

Completed Date: January 2016

Phase: Phase 2

Type: Interventional

Design:

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

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

Study sponsors, principal investigator, and references

Principal Investigator: Orville G Kolterman, MD

Lead Sponsor: NuSirt Biopharma

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02151461

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