Adult Subjects With Uncontrolled Type 2 Diabetes

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Melior Pharmaceuticals
• Collaborator: Bukwang Pharmaceutical, Co., Ltd.

Criteria

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