Adult Subjects With Uncontrolled Type 2 Diabetes
Completed · Phase 2 · Has a placebo group
Conditions studied: Type 2 Diabetes
In brief
A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes
Key facts
- Study ID
- NCT02317796
- Run by
- Melior Pharmaceuticals
- People needed
- 149
- Starts
- 2014-12-01
- Expected to finish
- 2016-02-01
- Last updated by the study team
- 2016-09-26
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Melior Pharmaceuticals I & Bukwang Pharm. Co., Ltd. — USA and South Korea, Pennsylvania, United States
Full record on ClinicalTrials.gov
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