NCT02317796

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

September 26, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

December 11, 2014

Last Update Submit

September 23, 2016

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in PPG AUC0-3h in a MMTT between Days 1 and 29.

    29 Days

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (5)

Placebo

PLACEBO COMPARATOR
Drug: MLR-1023

100 mg q.d.

ACTIVE COMPARATOR
Drug: MLR-1023

100 mg b.i.d.

ACTIVE COMPARATOR
Drug: MLR-1023

200 mg q.d.

ACTIVE COMPARATOR
Drug: MLR-1023

200 mg b.i.d.

ACTIVE COMPARATOR
Drug: MLR-1023

Interventions

MLR-1023DRUG

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.100 mg q.d.200 mg b.i.d.200 mg q.d.Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

USA and South Korea, Pennsylvania, United States

Location

Related Publications (1)

  • 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.

    PMID: 32019723DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

5-(3-methylphenoxy)-2(1H)-pyrimidinone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd.

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 16, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

September 26, 2016

Record last verified: 2016-09

Locations

US(1)