Trial | NCT02317796  Report issue

Title

Adult Subjects With Uncontrolled Type 2 Diabetes
A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    149
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

To assess the safety, tolerability and initial anti-diabetic activity of MLR-1023 in subjects with uncontrolled mild to moderate type 2 diabetes mellitus
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 Started
Dec 31
2014
Primary Completion
Dec 31
2015
Study Completion
Feb 29
2016
Last Update
Sep 26
2016
Estimate

Drug 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.

Placebo Placebo Comparator

100 mg q.d. Active Comparator

100 mg b.i.d. Active Comparator

200 mg q.d. Active Comparator

200 mg b.i.d. Active Comparator

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted