NCT01819272

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_2 type-2-diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

September 21, 2015

Completed
Last Updated

March 15, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

March 19, 2013

Results QC Date

August 21, 2015

Last Update Submit

February 6, 2017

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change in Fasting Plasma Glucose (mg/dL) at 4 Weeks

    Baseline and 4 weeks after the first dose of study medication

Secondary Outcomes (2)

  • AUC4-12wk of Change in Fasting Plasma Glucose (mg/dL*Week) Concentrations From Baseline to 12 Weeks

    Baseline and 4 to 12 weeks after the first dose of study medication

  • Change in HbA1c (%) at 12 Weeks

    Baseline and 12 weeks after the first dose of study medication

Study Arms (6)

600 mg DR

EXPERIMENTAL

600 mg delayed-release metformin once daily in the morning

Drug: Met DR

800 mg DR

EXPERIMENTAL

800 mg delayed-release metformin once daily in the morning

Drug: Met DR

1000 mg DR

EXPERIMENTAL

1000 mg delayed-release metformin once daily in the morning

Drug: Met DR

1000 mg XR

ACTIVE COMPARATOR

1000 mg extended-release metformin once daily in the evening

Drug: Met XR

2000 mg XR

ACTIVE COMPARATOR

2000 mg extended-release metformin once daily in the evening

Drug: Met XR

Placebo

PLACEBO COMPARATOR

Placebo once daily in the morning

Drug: Placebo

Interventions

Met DRDRUG

metformin delayed-release tablets

1000 mg DR600 mg DR800 mg DR
Met XRDRUG

metformin extended-release tablets

1000 mg XR2000 mg XR
PlaceboDRUG

placebo delayed-release tablets

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female with T2DM who was ≥18 and ≤65 years of age at Visit 1
  • Had a body mass index (BMI) of 25.0 kg/m² to 45.0 kg/m², inclusive, at Visit 1
  • Screening HbA1c 7.0 to 9.5% (inclusive) at Visit 1 if treated with diet and exercise alone, or 6.0 to 9.5% (inclusive) if on a stable dose of either metformin or DPP-4 inhibitor monotherapy for a minimum of 2 months at Visit 1, or a combination of these 2 agents only on a stable regimen for a minimum of 2 months at Visit 1
  • Had serum creatinine concentration of \<1.5 mg/dL (male) or \<1.4 mg/dL (female) and an estimated glomerular filtration rate (eGFR) of ≥60 mL/min/1.73 m² based on the Modification of Diet in Renal Disease (MDRD) equation
  • Had a fasting glucose concentration of \<280 mg/dL at Visit 1
  • Had a stable body weight, i.e., not varying by \>5% for at least 6 months prior to Visit 1 as documented by the investigator
  • Was male, or if female and met all of the following criteria:
  • Not breastfeeding
  • Negative pregnancy test result (human chorionic gonadotropin, beta subunit \[βhCG\]) at Visit 1 (not applicable to hysterectomized females)
  • If of child bearing potential (including perimenopausal women who have had a menstrual period within 1 year), must have practiced and be willing to continue to practice appropriate birth control during the entire duration of the study
  • Had a physical examination and ECG with no clinically significant abnormalities as judged by the investigator at Visit 1
  • Had no clinically significant laboratory test values (clinical chemistry, hematology, urinalysis) other than those expected in subjects with diabetes as judged by the investigator at Visit 1
  • Either was not treated with or had been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to Visit 1:
  • Hormone replacement therapy (female subjects)
  • Oral contraceptives (female subjects)
  • +8 more criteria

You may not qualify if:

  • Had a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
  • Hepatic disease
  • Renal disease
  • Gastrointestinal disease
  • Endocrine disorder except T2DM
  • Cardiovascular disease
  • Central nervous system diseases
  • Psychiatric or neurological disorders
  • Organ transplantation
  • Chronic or acute infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus)
  • Orthostatic hypotension, fainting spells or blackouts
  • Allergy or hypersensitivity
  • Clinically significant malignant disease (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of Visit 1
  • Had known hypersensitivity, intolerability, or allergies to metformin HCl or any component of study treatment
  • Had a physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Buse JB, DeFronzo RA, Rosenstock J, Kim T, Burns C, Skare S, Baron A, Fineman M. The Primary Glucose-Lowering Effect of Metformin Resides in the Gut, Not the Circulation: Results From Short-term Pharmacokinetic and 12-Week Dose-Ranging Studies. Diabetes Care. 2016 Feb;39(2):198-205. doi: 10.2337/dc15-0488. Epub 2015 Aug 18.

    PMID: 26285584BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Senior Director, Development
Organization
Elcelyx Therapeutics, Inc
info@elcelyx.com
858-876-1814

Study Officials

  • Andrew Lewin

    National Research Institute - Wilshire

    PRINCIPAL INVESTIGATOR

  • Rubin Saavedra

    Alliance Against Diabetes / AAD Clinical Research

    PRINCIPAL INVESTIGATOR

  • Lydie Hazan

    Axis Clinical Trials

    PRINCIPAL INVESTIGATOR

  • Robert Lipetz

    Encompass Clinical Research

    PRINCIPAL INVESTIGATOR

  • Audrey Lacour

    Juno Research, LLC - Houston

    PRINCIPAL INVESTIGATOR

  • Donald Hurley

    Medical Research South, LLC

    PRINCIPAL INVESTIGATOR

  • Eli M Roth

    Sterling Research Group, Ltd. - Auburn

    PRINCIPAL INVESTIGATOR

  • Robert Strzinek

    Protenium Clinical Research, LLC

    PRINCIPAL INVESTIGATOR

  • Richard Marple

    Castlerock Clinical Research Consultants, LLC

    PRINCIPAL INVESTIGATOR

  • Farah Sultan

    Achieve Clinical Research, LLC

    PRINCIPAL INVESTIGATOR

  • Thomas Moretto

    American Health Network - Indianapolis

    PRINCIPAL INVESTIGATOR

  • Azazuddin A Ahmed

    Apex Medical Research - Illinois

    PRINCIPAL INVESTIGATOR

  • Cynthia Strout

    Coastal Carolina Research Center

    PRINCIPAL INVESTIGATOR

  • John Pullman

    Big Sky Clinical Research

    PRINCIPAL INVESTIGATOR

  • Gregory Collins

    Charlotte Clinical Research

    PRINCIPAL INVESTIGATOR

  • David Hassman

    Comprehensive Clinical Research

    PRINCIPAL INVESTIGATOR

  • Leonard Zemel

    Creekside Endocrine Associates

    PRINCIPAL INVESTIGATOR

  • Diane Smith

    CSRA Partners in Health, Inc.

    PRINCIPAL INVESTIGATOR

  • Julio Rosenstock

    Dallas Diabetes and Endocrine Center

    PRINCIPAL INVESTIGATOR

  • David Johnson

    Searcy Medical Center

    PRINCIPAL INVESTIGATOR

  • Stephen Ong

    MD Medical Research

    PRINCIPAL INVESTIGATOR

  • Cynthia Huffman

    Meridien Research - Tampa

    PRINCIPAL INVESTIGATOR

  • Ramon Vargas

    New Orleans Center for Clinical Research

    PRINCIPAL INVESTIGATOR

  • Almena Free

    Pinnacle Research Group

    PRINCIPAL INVESTIGATOR

  • Douglas Short

    PMG Research of Raleigh, LLC

    PRINCIPAL INVESTIGATOR

  • Jonathan Wilson

    PMG Research of Winston-Salem, LLC

    PRINCIPAL INVESTIGATOR

  • Alexander White

    Progressive Medical Research

    PRINCIPAL INVESTIGATOR

  • Ronald Brazg

    Rainier Clinical Research Center

    PRINCIPAL INVESTIGATOR

  • Matthew Davis

    Rochester Clinical Research

    PRINCIPAL INVESTIGATOR

  • Charles Fogarty

    Spartanburg Medical Research

    PRINCIPAL INVESTIGATOR

  • Ralph DeFronzo

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

  • Craig S Thompson

    Craig S Thompson MD LLC

    PRINCIPAL INVESTIGATOR

  • Subodh Bhuchar

    Pioneer Research Solutions Inc.

    PRINCIPAL INVESTIGATOR

  • Susan Greco

    Jacksonville Center For Clinical Research

    PRINCIPAL INVESTIGATOR

  • Harold Bays

    Louisville Metabolic and Atherosclerosis Research Center

    PRINCIPAL INVESTIGATOR

  • Barry Lubin

    National Clinical Research - Norfolk, Inc.

    PRINCIPAL INVESTIGATOR

  • Mark Christiansen

    Diablo Clinical Research, Inc.

    PRINCIPAL INVESTIGATOR

  • Andrea Lawless

    Biofortis, Inc.

    PRINCIPAL INVESTIGATOR

  • Kathryn J Lucas

    Diabetes and Endocrinology Consultants, P.C.

    PRINCIPAL INVESTIGATOR

  • Hugo Toro

    Juno Research, LLC - Katy

    PRINCIPAL INVESTIGATOR

  • Eva M Heurich

    Compass Research, LLC

    PRINCIPAL INVESTIGATOR

  • Chander Arora

    RAS Health Ltd

    PRINCIPAL INVESTIGATOR

  • Patricia Buchanan

    Willamette Valley Clinical Studies

    PRINCIPAL INVESTIGATOR

  • Thomas Blevins

    Texas Diabetes & Endocrinology, P.A. - Austin

    PRINCIPAL INVESTIGATOR

  • Anna Chang

    John Muir Physician Network Clinical Research Center

    PRINCIPAL INVESTIGATOR

  • John Hoekstra

    National Clinical Research - Richmond, Inc.

    PRINCIPAL INVESTIGATOR

  • Lyle Myers

    Kentucky Diabetes Endocrinology Center

    PRINCIPAL INVESTIGATOR

  • Stephanie Shaw

    Texas Diabetes and Endocrinology, P.A. - Round Rock

    PRINCIPAL INVESTIGATOR

  • Purvi Mehra

    eStudySite

    PRINCIPAL INVESTIGATOR

  • Traci Turner

    Metabolic and Atherosclerosis Research Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2013

First Posted

March 27, 2013

Study Start

April 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 15, 2017

Results First Posted

September 21, 2015

Record last verified: 2017-02