Adult Subjects With Uncontrolled Type 2 Diabetes
- Registration Number
- NCT02317796
- Lead Sponsor
- Melior Pharmaceuticals
- Brief Summary
A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
- Diagnosed with uncontrolled T2DM who have received diet and exercise therapy for at least 3 months prior to screening, aged ≥ 18 - ≤ 75 years
- Females must be post-menopausal, unable to conceive, or test negative for pregnancy via blood test and use barrier contraception
- BMI ranging from ≥ 20 to ≤ 40 kg/m2
- Fasting plasma glucose values of up to 240 mg/dL at screening, after wash-out (visit 2) and after placebo run-in (visit 3)
- (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
-
History of Type 1 diabetes
-
History of more than 1 episode of severe hypoglycemia within 6 months prior to screening, or a current diagnosis of hypoglycemia unawareness.
-
Hospitalizations or Emergency room visits that would impact patient safety or data interpretation:
- Due to poor glucose control in the 6 months prior to screening or
- Any bariatric surgical procedures for weight loss.
-
Significant change of body weight (>10%) in the 3 months before screening
-
Proliferative retinopathy or maculopathy within the 6 months before screening or requiring acute treatment, or severe neuropathy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 100 mg b.i.d. MLR-1023 - Placebo MLR-1023 - 100 mg q.d. MLR-1023 - 200 mg b.i.d. MLR-1023 - 200 mg q.d. MLR-1023 -
- Primary Outcome Measures
Name Time Method Change in PPG AUC0-3h in a MMTT between Days 1 and 29. 29 Days
- Secondary Outcome Measures
Name Time Method Change in fasting plasma glucose in dose groups from Day 1 to Day 29, Day 36 36 Days Change in fructosamine level from Day 1 to Day 29 29 Days Change in fasting insulin from Day 1 to Day 29 29 Days Change in glycated albumin from Day 1 to Day 29 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) 29 Days Differences between placebo and MLR-1023 dose groups in PPG AUC0-3h Days 1 and 29. 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]) 29 Days Change in HbA1C between Days 1 and Day 29 29 Days Changes in LDL-C, HDL-C, TG between Days 1 and Day 29 29 Days Change in weight between Days 1 and Day 29 29 Days
Trial Locations
- Locations (1)
Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd.
🇺🇸USA and South Korea, Pennsylvania, United States
Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd.🇺🇸USA and South Korea, Pennsylvania, United States