Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

The purpose of the study is to compare the glycemic effects of delayed-release metformin (Met DR) to placebo in subjects with type 2 diabetes mellitus (T2DM) over 16 weeks. The study is designed to evaluate several doses of Met DR (600 to 1500 mg once daily in the morning \[qAM\]) compared to placebo. A single-blind reference treatment of 2000 mg metformin immediate-release (Met IR) per day administered as equal divided doses (1000 mg Met IR BID) will also be included.

Key facts

Study ID

NCT02526524

Run by

Elcelyx Therapeutics, Inc.

People needed

571

Starts

2015-09-01

Expected to finish

2016-09-01

Last updated by the study team

2018-04-27

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is at least 25 years old at Visit 1 (Screening).
• Is male, or is female and meets all of the following criteria:
• Not breastfeeding
• Negative pregnancy test result at Visit 1 (not applicable to post-menopausal or surgically sterile females)
• Surgically sterile, postmenopausal, or if of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study.
• Body mass index (BMI) 20.0 to 45.0 kg/m² (inclusive) at Visit 1 (Screening).
• Has a physical examination with no clinically significant abnormalities as judged by the investigator.
• Has T2DM and an HbA1c of 7.5% to 10.5%, inclusive, at Visit 1.
• Has an estimated glomerular filtration rate (eGFR) value of ≥60 mL/min/1.73 m² based on the Modification of Diet in Renal Disease (MDRD) equation.
• Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 3 months prior to Visit 1:
• Thiazolidinedione, sulfonylurea, dipeptidyl peptidase-4 inhibitors, and alpha-glucosidase inhibitors
• Hormone replacement therapy (female subjects) and testosterone (male subjects)
• Oral contraceptives (female subjects)
• Antihypertensive agents
• Lipid-lowering agents
• Thyroid replacement therapy
• Antidepressant agents
• Ability to understand and willingness to adhere to protocol requirements.

You may not qualify if…

• Has a clinically significant medical condition as judged by the investigator that could potentially affect study participation and/or personal well-being, including but not limited to the following conditions:
• Hepatic disease
• Gastrointestinal disease
• Endocrine disorder (T2DM is allowed)
• Cardiovascular disease
• Central nervous system diseases
• Psychiatric or neurological disorders
• Organ transplantation
• Chronic or acute infection
• Orthostatic hypotension, fainting spells or blackouts
• Allergy or hypersensitivity.
• A history of diabetic ketoacidosis or hyperosmolar non-ketotic hyperglycemia within the past year.
• Prior major surgery of any kind within 6 months of Visit 1.
• A history of >3% weight change within 3 months of Visit 1.
• A clinical laboratory test (clinical chemistry, hematology, or urinalysis) abnormality, other than that related to T2DM, judged by the investigator to be clinically significant at Visit 1.
• An alanine aminotransferase or aspartate aminotransferase result >2.5 × upper limit of normal (ULN) or a bilirubin result >1.5 × ULN.
• A physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study.
• Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following excluded medications:
• Metformin within 2 months of Visit 1 (Screening)
• Insulin within 2 weeks of Visit 1 (Screening) or for more than 1 week within 3 months of Visit 1 (Screening)
• Glucagon-like peptide-1 receptor agonists or sodium-glucose co-transporter 2 inhibitors within 3 months of Visit 1
• Drugs known to affect body weight, including prescription medications and over-the-counter anti obesity agents within 3 months of Visit 1.
• Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption within 3 months of Visit 1
• Planned use of any drug treatment that affects gastric pH (prescription or over-the-counter), such as H2-receptor antagonists and proton pump inhibitors, after Visit 2 (Week -2), or planned chronic use of any antacids (i.e., more than twice per week) after Visit 2 (Week -2)
• Cationic drugs that are eliminated by renal tubular secretion within 1 week of Visit 1.

Where it is running

• Central Alabama Research — Birmingham, Alabama, United States
• Achieve Clinical Research, LLC — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Terence T. Hart, MD — Tuscumbia, Alabama, United States
• Radiant Research - Phoenix — Chandler, Arizona, United States
• Arrowhead Health Centers — Glendale, Arizona, United States
• Holland Center for Family Health, LTD — Peoria, Arizona, United States
• Elite Clinical Studies — Phoenix, Arizona, United States
• Thunderbird Internal Medicine - Indian School Rd. — Phoenix, Arizona, United States
• Clinical Research Institute of Arizona, LLC — Surprise, Arizona, United States
• Summit Clinical Trials Center — Fayetteville, Arkansas, United States
• Searcy Medical Center — Searcy, Arkansas, United States
• Advanced Metabolic Care & Research Institute (AMCR) — Escondido, California, United States
• MD Studies, Inc. — Fountain Valley, California, United States
• National Research Institute — Huntington Park, California, United States
• Scripps Whittier Diabetes Institute — La Jolla, California, United States
• Clinical Trials Research — Lincoln, California, United States
• Collaborative Neuroscience Network, LLC — Long Beach, California, United States
• National Research Institute — Los Angeles, California, United States
• Catalina Research Institute — Montclair, California, United States
• SRSD, Inc. dba Synergy San Diego — National City, California, United States
• Providence Clinical Research — North Hollywood, California, United States
• Pacific Research Partners, LLC — Oakland, California, United States
• SDS Clinical Trials, Inc. — Orange, California, United States
• Pinnacle Research Group, LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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