Assessing the Efficacy, Safety, and Tolerability of Met DR in Subjects With T2DM Over 12 Weeks

Summary

This study compared the effect of delayed-release metformin (Met DR) to placebo and extended release metformin (Met XR) on glycemic control (fasting plasma glucose and HbA1c) and body weight, and assessed the safety and tolerability of a range of doses of Met DR when administered in subjects with type 2 diabetes mellitus (T2DM).

Conditions

• Type 2 Diabetes Mellitus

Interventions

DRUG

Met DR

metformin delayed-release tablets

DRUG

Met XR

metformin extended-release tablets

DRUG

Placebo

placebo delayed-release tablets

Sponsors & Collaborators

• Elcelyx Therapeutics, Inc.

  lead INDUSTRY

Principal Investigators

• Andrew Lewin · National Research Institute - Wilshire

• Rubin Saavedra · Alliance Against Diabetes / AAD Clinical Research

• Lydie Hazan · Axis Clinical Trials

• Robert Lipetz · Encompass Clinical Research

• Audrey Lacour · Juno Research, LLC - Houston

• Donald Hurley · Medical Research South, LLC

• Eli M Roth · Sterling Research Group, Ltd. - Auburn

• Robert Strzinek · Protenium Clinical Research, LLC

• Richard Marple · Castlerock Clinical Research Consultants, LLC

• Farah Sultan · Achieve Clinical Research, LLC

• Thomas Moretto · American Health Network - Indianapolis

• Azazuddin A Ahmed · Apex Medical Research - Illinois

• Cynthia Strout · Coastal Carolina Research Center

• John Pullman · Big Sky Clinical Research

• Gregory Collins · Charlotte Clinical Research

• David Hassman · Comprehensive Clinical Research

• Leonard Zemel · Creekside Endocrine Associates

• Diane Smith · CSRA Partners in Health, Inc.

• Julio Rosenstock · Dallas Diabetes and Endocrine Center

• David Johnson · Searcy Medical Center

• Stephen Ong · MD Medical Research

• Cynthia Huffman · Meridien Research - Tampa

• Ramon Vargas · New Orleans Center for Clinical Research

• Almena Free · Pinnacle Research Group

• Douglas Short · PMG Research of Raleigh, LLC

• Jonathan Wilson · PMG Research of Winston-Salem, LLC

• Alexander White · Progressive Medical Research

• Ronald Brazg · Rainier Clinical Research Center

• Matthew Davis · Rochester Clinical Research

• Charles Fogarty · Spartanburg Medical Research

• Ralph DeFronzo · The University of Texas Health Science Center at San Antonio

• Craig S Thompson · Craig S Thompson MD LLC

• Subodh Bhuchar · Pioneer Research Solutions Inc.

• Susan Greco · Jacksonville Center For Clinical Research

• Harold Bays · Louisville Metabolic and Atherosclerosis Research Center

• Barry Lubin · National Clinical Research - Norfolk, Inc.

• Mark Christiansen · Diablo Clinical Research, Inc.

• Andrea Lawless · Biofortis, Inc.

• Kathryn J Lucas · Diabetes and Endocrinology Consultants, P.C.

• Hugo Toro · Juno Research, LLC - Katy

• Eva M Heurich · Compass Research, LLC

• Chander Arora · RAS Health Ltd

• Patricia Buchanan · Willamette Valley Clinical Studies

• Thomas Blevins · Texas Diabetes & Endocrinology, P.A. - Austin

• Anna Chang · John Muir Physician Network Clinical Research Center

• John Hoekstra · National Clinical Research - Richmond, Inc.

• Lyle Myers · Kentucky Diabetes Endocrinology Center

• Stephanie Shaw · Texas Diabetes and Endocrinology, P.A. - Round Rock

• Purvi Mehra · eStudySite

• Traci Turner · Metabolic and Atherosclerosis Research Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2013-09-30

Completion

2013-09-30