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Assessing the Behavior of Met DR in Subjects With Kidney Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01658514
Recruitment Status : Completed
First Posted : August 7, 2012
Results First Posted : December 30, 2015
Last Update Posted : December 30, 2015
Information provided by (Responsible Party):
Elcelyx Therapeutics, Inc.

Brief Summary:
This study evaluated how a single dose of delayed-release metformin (Met DR) behaves in subjects with normal kidney function, mild kidney dysfunction, moderate kidney dysfunction, or severe kidney dysfunction. The safety and tolerability of Met DR was also examined. In addition, this study compared the behavior of a single dose of Met DR with that of extended-release metformin (Met XR) and placebo in subjects with the varying levels of kidney function described above.

Condition or disease Intervention/treatment Phase
Renal Insufficiency Drug: Met DR Drug: Met XR Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Crossover Study Assessing the Single Dose Pharmacokinetics of Delayed-Release Metformin in Subjects With Renal Dysfunction
Study Start Date : January 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin

Arm Intervention/treatment
Experimental: Met DR
One dose of 1000 mg metformin delayed-release
Drug: Met DR
metformin delayed-release tablets

Active Comparator: Met XR
One dose of 1000 mg metformin extended-release
Drug: Met XR
metformin extended-release tablets

Placebo Comparator: Placebo
One dose of Placebo
Drug: Placebo

Primary Outcome Measures :
  1. AUC (0-t) of Plasma Metformin [ Time Frame: from the time of dosing (0 h) to 72 hours postdose ]
    AUC (0-t) = Area under the curve from the time of dosing (0 h) to the time of the last quantifiable concentration following dose administration

  2. Cmax of Plasma Metformin [ Time Frame: from the time of dosing (0 h) to 72 hours postdose ]
    Cmax = Maximum concentration from the time of dosing (0 h) to the time of the last quantifiable metformin concentration following dose administration

  3. Correlation of Placebo-adjusted Change From Pre-dose Value in Lactate Versus Metformin Concentration [ Time Frame: from the time of dosing (0 h) to 24 hours postdose ]
    To determine the exposure-response relationship of metformin and plasma lactate concentrations

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. 18 to 80 (inclusive) years old at Visit 1 (Screening)
  2. Male, or female and met all of the following criteria:

    • Not breastfeeding
    • Negative pregnancy test result at Visit 1 (Screening) (not applicable to postmenopausal or surgically sterile females)
    • Surgically sterile, postmenopausal, or if of childbearing potential, practiced and was willing to continue to practice appropriate birth control during the entire duration of the study
    • Body weight of ≥45 kg
  3. Body mass index (BMI) of 18.0 to 40.0 kg/m² (inclusive) at Visit 1 (Screening)
  4. Had type 2 diabetes mellitus and an HbA1c ≤10.0%
  5. Had a physical examination with no clinically significant abnormalities as judged by the investigator
  6. Estimated glomerular filtration rate (eGFR) ≥15 mL/min/1.73 m² based on the Modification of Diet in Renal Disease (MDRD) equation
  7. Ability to understand and willingness to adhere to protocol requirements

Exclusion Criteria:

  1. Had End Stage Renal Disease requiring dialysis or severe renal dysfunction with eGFR <15 mL/min/1.73 m²
  2. Was on dialysis or had been on dialysis within 12 months of Visit 1 (Screening)
  3. Had received or planned to receive any iodinated contrast dye within 1 week prior to Visit 1 (Screening) or after study medication administration
  4. Was taking or had taken within 1 week of Visit 1 cationic drugs that are eliminated by renal tubular secretion (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin)
  5. 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
    • Gastrointestinal disease
    • Endocrine disorder (type 2 diabetes mellitus was 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
  6. Had any chronic disease requiring medication that had been adjusted in the past 14 days (subjects could take acute intermittent over-the-counter medications such as Tylenol, if needed)
  7. Had major surgery of any kind within 6 months of Visit 1 (Screening)
  8. Had a clinically significant finding of an electrocardiogram (ECG) as assessed by the investigator at Visit 1 (Screening)
  9. Had clinical laboratory test (clinical chemistry, hematology, or urinalysis) abnormalities, other than those related to diabetes or renal disease and other stable diseases, judged by the investigator to be clinically significant at Visit 1 (Screening)
  10. Had a hemoglobin result <8 g/dL or a level indicating severe anemia of renal origin
  11. Had a physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study
  12. Had received Byetta® or short-acting insulin within 3 days of Visit 1 (Screening)
  13. Had received metformin within 4 weeks of Visit 1 (Screening)
  14. Had any drug treatment that affects gastrointestinal motility or gastric pH (prescription or over-the-counter), including any antacids or medications such as Rolaids or Pepcid, within 2 days of Visit 2
  15. Abused drugs or alcohol or had a history of abuse that in the investigator's opinion would cause the individual to be noncompliant with study procedures
  16. Smoked more than 10 cigarettes, 3 cigars, or 3 pipes per day
  17. Had donated blood within 2 months of Visit 1 (Screening) or was planning to donate blood during the study
  18. Had received any investigational drug within one month (or seven half-lives of the investigational drug, whichever was greater) of Visit 1 (Screening)
  19. Had known allergies or hypersensitivity to any component of study treatment
  20. Was employed by Elcelyx Therapeutics, Inc (that is an employee, temporary contract worker, or designee of the company)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01658514

Sponsors and Collaborators
Elcelyx Therapeutics, Inc.
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Principal Investigator: George Canas, MD Prism Research
Principal Investigator: Kenneth Lasseter, MD Clinical Pharmacology of Miami, Inc
Principal Investigator: Alexander White, MD Progressive Medical Research
Principal Investigator: Harold Bays, MD Louisville Metabolic and Atherosclerosis Research Center
Principal Investigator: Craig Curtis, MD Compass Research
Principal Investigator: Prabir Roy-Chaudhury Cincinnati Veterans Affairs Medical Center Department of Internal Medicine
Principal Investigator: Sunder Mudaliar San Diego Veterans Healthcare System
Principal Investigator: Nelson Kopyt Northeast Clinical Research Center

Publications of Results:
Bakris GL, Mudaliar, S, Kim T, Burns C, Skare S, Baron A, Fineman M. Effects of New Metformin Formulation in Stage 3 and 4 CKD: A Pilot Study. J Am Soc Nephrol. 2014; 25:549A.

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Responsible Party: Elcelyx Therapeutics, Inc. Identifier: NCT01658514    
Other Study ID Numbers: LCRM101
First Posted: August 7, 2012    Key Record Dates
Results First Posted: December 30, 2015
Last Update Posted: December 30, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs