An Add-on Study of MLR-1023 in Adults With Uncontrolled Type 2 Diabetes on Metformin Therapy

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT03279263

Run by

Melior Pharmaceuticals

People needed

400

Starts

2017-09-01

Expected to finish

2019-09-01

Last updated by the study team

2019-01-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age 18 to 75 years, inclusive.
• Diagnosis of T2DM.
• Body mass index (BMI) between 20 and 40 kg/m2.
• HbA1C between 7.0% and 10.0%.
• Treated with metformin as the only anti-diabetic therapy.
• Metformin dosage must have been stable and unchanged for at least 3 months prior to Screening and at a dose of at least 1,500 mg/day or the maximum tolerated dose if less than 1,500 mg/day.
• Able and willing to comply with the study protocol for the duration of the study including scheduled clinic appointments.
• Able and willing to provide written informed consent for study participation prior to performance of any study-related assessments.

You may not qualify if…

• Subject has signs of or is diagnosed with Type 1 diabetes mellitus or latent autoimmune diabetes in adults.
• History of hospitalizations or emergency room visits that would impact subject safety or data interpretation, including:
• Poor glucose control in the 6 months prior to Screening (per investigator discretion) or
• Any bariatric surgical procedures for weight loss.
• History of significant change of body weight (> 10%) in the 3 months prior to Screening.
• History of or active proliferative retinopathy or maculopathy within the 6 months before Screening or requiring acute treatment, or severe neuropathy.
• History of previous gastrointestinal bleeding or ulceration within 3 months prior to Screening.
• History of acute or chronic pancreatitis.
• History of significant cardiovascular events defined as:
• Myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within 6 months prior to Screening.
• Congestive heart failure defined as New York Heart Association (NYHA) Stages III and IV.
• Uncontrolled hypertension defined as a systolic blood pressure > 160 mmHg and/or a diastolic blood pressure > 100 mmHg.
• Symptomatic postural hypotension - The difference between supine blood pressure and standing blood pressure is 20 mmHg in systolic or 10 mmHg in diastolic with any symptom.
• Evidence of uncorrected hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid stimulating hormone result as determined at Screening; subjects receiving dose-stable thyroid replacement therapy for at least 3 months prior to Screening will be allowed to participate in the study.
• History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder that would impact subject safety or data interpretation.
• History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening ( subjects with a history of treated cervical intraepithelial neoplasia will be allowed to participate in the study).
• Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN) and/or alanine aminotransferase (ALT) > 2.5 × ULN and/or total bilirubin > 2.0 mg/dL.
• Positive blood screen for anti-hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), and human immunodeficiency (HIV) antibody.
• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, ECG, or clinical laboratory assessments.
• Long QT syndrome or prolongation of QTc interval (defined as QTc interval > 460 ms for males and > 480 ms for females).
• The following medication exclusions apply:
• Use of weight control treatment 3 months prior to Screening, including any medication with a labeled reference to weight loss or gain, herbal preparations, and over the counter medications.
• Use of other anti-diabetic agents (except metformin) within 3 months prior to Screening (if the subject was previously treated with thiazolidinedione, he/she must have stopped this treatment at least 6 months before Screening).
• Use of insulin within 12 months prior to Screening (the following cases can be included in this study: Insulin treatment during hospitalization, insulin treatment for a medical condition that did not require hospitalization [< 2 weeks treatment period], or insulin treatment for gestational diabetes).
• Treatment with an investigational agent within the longest time frame of either 5 half lives or 30 days of initiating study drug.

Where it is running

• National Research Institute — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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