Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
149 participants
INTERVENTIONAL
2014-12-31
2016-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
MLR-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.
100 mg q.d.
MLR-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.
100 mg b.i.d.
MLR-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.
200 mg q.d.
MLR-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.
200 mg b.i.d.
MLR-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.
Interventions
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MLR-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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Bukwang Pharmaceutical, Co., Ltd.
INDUSTRY
Melior Pharmaceuticals
OTHER
Responsible Party
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Principal Investigators
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Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd.
Role: STUDY_DIRECTOR
Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd.
Locations
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Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd.
USA and South Korea, Pennsylvania, United States
Countries
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References
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Lee MK, Kim SG, Watkins E, Moon MK, Rhee SY, Frias JP, Chung CH, Lee SH, Block B, Cha BS, Park HK, Kim BJ, Greenway F. A novel non-PPARgamma insulin sensitizer: MLR-1023 clinicalproof-of-concept in type 2 diabetes mellitus. J Diabetes Complications. 2020 May;34(5):107555. doi: 10.1016/j.jdiacomp.2020.107555. Epub 2020 Feb 2.
Other Identifiers
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BK-MD-201
Identifier Type: -
Identifier Source: org_study_id
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