Type 2 Diabetes
Conditions
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.
Interventions
DRUGMLR-1023
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.
Sponsors
Bukwang Pharmaceutical, Co., Ltd.
Melior Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in PPG AUC0-3h in a MMTT between Days 1 and 29. | 29 Days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change in fasting plasma glucose in dose groups from Day 1 to Day 29, Day 36 | 36 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 |
| 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 |
Countries
United States
Outcome results
None listed