A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
149
Each subject will receive an oral dose of placebo or MLR-1023 once before breakfast and either placebo (placebo and q.d. dose groups) or a second dose of MLR-1023 (b.i.d. dose groups) before dinner for 4 weeks.
Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd.
USA and South Korea, Pennsylvania, United States
Change in PPG AUC0-3h in a MMTT between Days 1 and 29.
Time frame: 29 Days
Change in fasting plasma glucose in dose groups from Day 1 to Day 29, Day 36
Time frame: 36 Days
Change in fructosamine level from Day 1 to Day 29
Time frame: 29 Days
Change in fasting insulin from Day 1 to Day 29
Time frame: 29 Days
Change in glycated albumin from Day 1 to Day 29
Time frame: 29 Days
Change from Day 1 to Day 29 in insulin sensitivity using HOMA-R (HOMA-R = fasting plasma insulin (mU/l) * fasting plasma glucose (mmol/l) / 22.5)
Time frame: 29 Days
Changes from Day 1 to Day 29 in beta-cell function using HOMA-B (HOMA-B = 20 * fast- ing plasma insulin (mU/l) / [fasting plasma glucose (mmol/l) - 3.5])
Time frame: 29 Days
Change in HbA1C between Days 1 and Day 29
Time frame: 29 Days
Changes in LDL-C, HDL-C, TG between Days 1 and Day 29
Time frame: 29 Days
Change in weight between Days 1 and Day 29
Time frame: 29 Days
Differences between placebo and MLR-1023 dose groups in PPG AUC0-3h Days 1 and 29.
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Time frame: 29 Days