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

This study has been completed.
Information provided by (Responsible Party):
Elcelyx Therapeutics, Inc. Identifier:
First received: March 19, 2013
Last updated: February 6, 2017
Last verified: February 2017
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).

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Met DR
Drug: Met XR
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Delayed-Release Metformin in Subjects With Type 2 Diabetes Mellitus

Further study details as provided by Elcelyx Therapeutics, Inc.:

Primary Outcome Measures:
  • Change in Fasting Plasma Glucose (mg/dL) at 4 Weeks [ Time Frame: Baseline and 4 weeks after the first dose of study medication ]

Secondary Outcome Measures:
  • AUC4-12wk of Change in Fasting Plasma Glucose (mg/dL*Week) Concentrations From Baseline to 12 Weeks [ Time Frame: Baseline and 4 to 12 weeks after the first dose of study medication ]
  • Change in HbA1c (%) at 12 Weeks [ Time Frame: Baseline and 12 weeks after the first dose of study medication ]

Enrollment: 240
Study Start Date: April 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 600 mg DR
600 mg delayed-release metformin once daily in the morning
Drug: Met DR
metformin delayed-release tablets
Experimental: 800 mg DR
800 mg delayed-release metformin once daily in the morning
Drug: Met DR
metformin delayed-release tablets
Experimental: 1000 mg DR
1000 mg delayed-release metformin once daily in the morning
Drug: Met DR
metformin delayed-release tablets
Active Comparator: 1000 mg XR
1000 mg extended-release metformin once daily in the evening
Drug: Met XR
metformin extended-release tablets
Active Comparator: 2000 mg XR
2000 mg extended-release metformin once daily in the evening
Drug: Met XR
metformin extended-release tablets
Placebo Comparator: Placebo
Placebo once daily in the morning
Drug: Placebo
placebo delayed-release tablets


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female with T2DM who was ≥18 and ≤65 years of age at Visit 1
  2. Had a body mass index (BMI) of 25.0 kg/m² to 45.0 kg/m², inclusive, at Visit 1
  3. 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
  4. 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
  5. Had a fasting glucose concentration of <280 mg/dL at Visit 1
  6. 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
  7. Was male, or if female and met all of the following criteria:

    1. Not breastfeeding
    2. Negative pregnancy test result (human chorionic gonadotropin, beta subunit [βhCG]) at Visit 1 (not applicable to hysterectomized females)
    3. 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
  8. Had a physical examination and ECG with no clinically significant abnormalities as judged by the investigator at Visit 1
  9. 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
  10. 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:

    1. Hormone replacement therapy (female subjects)
    2. Oral contraceptives (female subjects)
    3. Antihypertensive agents
    4. Lipid-lowering agents
    5. Thyroid replacement therapy
    6. Antidepressant agents
    7. Testosterone therapy (male subjects)
  11. If on chronic thyroid pharmacologic therapy, had a serum thyroid-stimulating hormone test result within the normal range at Visit 1
  12. Was willing and able to follow study procedures
  13. Was able to read, understand, and sign the Informed Consent Form and an Authorization to Use and Disclose Protected Health Information form, answer the study questions, communicate with the investigator, and understand and comply with protocol requirements

Exclusion Criteria:

  1. 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:

    1. Hepatic disease
    2. Renal disease
    3. Gastrointestinal disease
    4. Endocrine disorder except T2DM
    5. Cardiovascular disease
    6. Central nervous system diseases
    7. Psychiatric or neurological disorders
    8. Organ transplantation
    9. Chronic or acute infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus)
    10. Orthostatic hypotension, fainting spells or blackouts
    11. Allergy or hypersensitivity
  2. Clinically significant malignant disease (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of Visit 1
  3. Had known hypersensitivity, intolerability, or allergies to metformin HCl or any component of study treatment
  4. Had a physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study
  5. Current drugs or alcohol abuse or had a history of abuse that in the investigator's opinion would cause the individual to be noncompliant with study procedures
  6. Had major surgery or a blood transfusion within 2 months of Visit 1 or was planning to donate blood during the study, or had a significant blood loss within 2 months prior to Visit 1
  7. Had been treated, was being treated, or was expected to require or undergo treatment with any of the following excluded medications:

    1. Insulin or sulphonylurea treatment within 3 months of Visit 1
    2. GLP-1 receptor agonists and/or thiazolidinedione treatment within 6 months of Visit 1
    3. Nifedipine within 3 months of Visit 1
    4. Systemic corticosteroids by oral, intravenous, intra-articular, or intra-muscular route within 30 days of screening or for more than 1 week within 3 months of Visit 1
    5. Prescription weight loss medications within 3 months of Visit 1
    6. Chronic or frequent use, in the judgment of the investigator, of any drug treatment that affects gastric pH (prescription or over-the-counter), including proton pump inhibitors or any antacids or medications such as Rolaids or Pepcid within 1 month of Visit 1
    7. Had received or planned to receive any iodinated contrast dye within 1 week prior to Visit 1 (Screening)
  8. Had a surgical gastrointestinal procedure that may impact the gut hormonal response to study medication
  9. History or presence of inflammatory bowel disease or other severe gastrointestinal disease, particularly those which may impact gastric emptying, such as gastroparesis, pyloric stenosis, gastric bypass surgery or gastric banding surgery
  10. Had received any investigational drug within 30 days (or five half-lives of the investigational drug, whichever was greater) of Visit 1
  11. Was an immediate family member (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the clinical study site, or was directly affiliated with the study at the clinical study site
  12. Was employed by Elcelyx Therapeutics, Inc. (that is an employee, temporary contract worker, or designee responsible for the conduct of the study)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01819272

Sponsors and Collaborators
Elcelyx Therapeutics, Inc.
Principal Investigator: 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, Inc
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 Clinical Research Center
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
  More Information

Responsible Party: Elcelyx Therapeutics, Inc. Identifier: NCT01819272     History of Changes
Other Study ID Numbers: LCRM105
Study First Received: March 19, 2013
Results First Received: August 21, 2015
Last Updated: February 6, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 25, 2017