Expired Study
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USA and South Korea, Pennsylvania


Purpose:

A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes


Study summary:

Objectives 1. To assess the safety, tolerability and initial anti-diabetic activity of MLR-1023 in subjects with uncontrolled mild to moderate type 2 diabetes mellitus 2. To evaluate the pharmacokinetics of MLR-1023 and the major metabolite, MLR-1023-M1 following 28 days of repeat dosing Design and Outcomes The study is a randomized, double blind, placebo-controlled, parallel group study of MLR-1023 in adult subjects with uncontrolled type 2 diabetes mellitus who are on diet and exercise therapy. A subset of subjects per dose group will have additional samples analyzed to measure signs of MLR-1023.


Criteria:

Inclusion Criteria: 1. Diagnosed with uncontrolled T2DM who have received diet and exercise therapy for at least 3 months prior to screening, aged ≥ 18 - ≤ 75 years 2. Females must be post-menopausal, unable to conceive, or test negative for pregnancy via blood test and use barrier contraception 3. BMI ranging from ≥ 20 to ≤ 40 kg/m2 4. Fasting plasma glucose values of up to 240 mg/dL at screening, after wash-out (visit 2) and after placebo run-in (visit 3) 5. (i) naïve or (ii) currently using and discontinued metformin or (iii) no prior exposure to anti-diabetic agents other than metformin ≥ 6 months prior to screening Exclusion Criteria: 1. History of Type 1 diabetes 2. History of more than 1 episode of severe hypoglycemia within 6 months prior to screening, or a current diagnosis of hypoglycemia unawareness. 3. Hospitalizations or Emergency room visits that would impact patient safety or data interpretation: 1. Due to poor glucose control in the 6 months prior to screening or 2. Any bariatric surgical procedures for weight loss. 4. Significant change of body weight (>10%) in the 3 months before screening 5. Proliferative retinopathy or maculopathy within the 6 months before screening or requiring acute treatment, or severe neuropathy


NCT ID:

NCT02317796


Primary Contact:

Study Director
Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd.
Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd.


Backup Contact:

N/A


Location Contact:

USA and South Korea, Pennsylvania
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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