Adult Subjects With Uncontrolled Type 2 Diabetes

Melior Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: MLR-1023

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02317796

BK-MD-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 149 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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149 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: MLR-1023

100 mg q.d.

Active Comparator group

Treatment:

Drug: MLR-1023

100 mg b.i.d.

Active Comparator group

Treatment:

Drug: MLR-1023

200 mg q.d.

Active Comparator group

Treatment:

Drug: MLR-1023

200 mg b.i.d.

Active Comparator group

Treatment:

Drug: MLR-1023