Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Add-on Study of MLR 1023 in Adults With Uncontrolled Type 2 Diabetes on Metformin Therapy
This Phase 2, multi-center, double-blind, randomized, placebo-controlled, parallel group, add-on study of MLR 1023 in adults with uncontrolled T2DM on metformin anti diabetic monotherapy is designed to evaluate the efficacy and safety of MLR 1023 in combination with metformin in subjects with uncontrolled T2DM.
Medical management of T2DM involves diet, exercise, weight management, and pharmacotherapy.
Pharmacological agents, such as metformin, α-glucosidase inhibitors, orlistat, and
thiazolidinediones, have been shown to decrease incident diabetes. Metformin has the
strongest evidence base and demonstrated long-term safety as pharmacological therapy for
diabetes treatment. The American Diabetes association position statement on diabetes care
recommends that if Hemoglobin A1C (HbA1C) targets are not achieved after approximately 3
months of metformin anti-diabetic monotherapy, a combination of metformin and one of several
oral treatment options should be considered.
In this study, subjects with a diagnosis of T2DM who are not adequately controlled (HbA1C
between 7.0% and 10.0%, inclusive) and started metformin therapy at least 3 months prior to
Screening will be recruited into the study. Subjects will continue taking metformin for the
duration of the study and once daily oral MLR 1023 or placebo will be added to metformin.
The efficacious dose-level range of MLR 1023 in diabetic subjects is anticipated to be
between 25 and 100 mg. Therefore, the efficacy, safety, and tolerability of 25 mg and 50 mg
doses in addition to the 100 mg dose that was shown to be effective in the Phase 2a proof of
concept study will be assessed.
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