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

NCT03279263 | Unknown Phase 2 FDA Drug

• 1 other identifier: BK-MD-202
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Changes in HbA1c between active treatment groups and placebo at Week 12

  Change in HbA1c from Baseline to Week 12

  12 Weeks

Secondary Outcomes (6)

• HbA1c of < 7.0% at Week 12

  12 Weeks

• HbA1c of < 6.5% at Week 12

  12 Weeks

• Changes in Fasting Plasma Glucose (FPG) from Baseline to Week 12 between active treatment groups and placebo

  12 Weeks

• Changes in fasting insulin, insulin sensitivities (HOMA IR)

  12 Weeks

• Changes in lipid profile (low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides)

  12 Weeks

Study Arms (4)

MLR-1023 25mg QD

EXPERIMENTAL

MLR-1023 25mg QD Tablet

Drug: MLR-1023

MLR-1023 50mg QD

EXPERIMENTAL

MLR-1023 50mg QD Tablet

Drug: MLR-1023

MLR-1023 100mg QD

EXPERIMENTAL

MLR-1023 100mg QD Tablet

Drug: MLR-1023

Placebo

PLACEBO COMPARATOR

Placebo QDTablet

Other: Placebo

Interventions

MLR-1023 DRUG

MLR-1023 Tablets

MLR-1023 100mg QD; MLR-1023 25mg QD; MLR-1023 50mg QD

Placebo OTHER

Matching Placebo Tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Melior Pharmaceuticals: lead
• Bukwang Pharmaceutical, Co., Ltd.: collaborator

Study Sites (1)

National Research Institute

Los Angeles, California, 90057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

5-(3-methylphenoxy)-2(1H)-pyrimidinone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ramana Kuchibhatla, PhD

  Melior Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: September 12, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

US (1)