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

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

Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled, Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release In Subjects With Type 2 Diabetes Mellitus

NCT02526524•Elcelyx Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

25 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Is at least 25 years old at Visit 1 (Screening).
•2. Is male, or is female and meets all of the following criteria:
•1. Not breastfeeding
•2. Negative pregnancy test result at Visit 1 (not applicable to post-menopausal or surgically sterile females)
•3. 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.
•3. Body mass index (BMI) 20.0 to 45.0 kg/m² (inclusive) at Visit 1 (Screening).
•4. Has a physical examination with no clinically significant abnormalities as judged by the investigator.
•5. Has T2DM and an HbA1c of 7.5% to 10.5%, inclusive, at Visit 1.
•6. 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.
•7. 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:
+8 more criteria

Exclusion Criteria

•1. 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:
•1. Hepatic disease
•2. Gastrointestinal disease
•3. Endocrine disorder (T2DM is allowed)
•4. Cardiovascular disease
•5. Central nervous system diseases
•6. Psychiatric or neurological disorders
•7. Organ transplantation
•8. Chronic or acute infection
•9. Orthostatic hypotension, fainting spells or blackouts
+23 more criteria

Locations (137)

Pinnacle Research Group, LLC

Anniston, Alabama, United States

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

Key Dates

Start Date

September 1, 2015

Primary Completion Date

September 1, 2016

Completion Date

September 1, 2016

Last Updated

April 27, 2018

Enrollment

571

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

Met DR

DRUG

Met IR

DRUG

Placebo

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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