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12-Week, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Metformin DR in Subjects With Type 2 Diabetes Mellitus

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Elcelyx Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01819272
First received: March 19, 2013
Last updated: May 17, 2013
Last verified: April 2013
  Purpose

To compare the effect of delayed-release metformin to placebo on glycemic control (fasting plasma glucose and HbA1c) and body weight when administered in subjects with type 2 diabetes mellitus.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: delayed-release metformin
Drug: extended-release metformin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • Number of participants with adverse events as a measure of safety and tolerability at 4 weeks [ Time Frame: Baseline through 4 weeks after the first dose of study medication ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in fasting plasma glucose (mg/dL) at 12 weeks [ Time Frame: Baseline and 12 weeks after the first dose of study medication ] [ Designated as safety issue: No ]
  • Number of participants with adverse events as a measure of safety and tolerability at 12 weeks [ Time Frame: Baseline through 12 weeks after the first dose of study medication ] [ Designated as safety issue: Yes ]
  • Change in HbA1c (%) at 12 weeks [ Time Frame: Baseline and 12 weeks after the first dose of study medication ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female with type 2 diabetes who are ≥18 and ≤65 years of age at Visit 1.
  2. Has a 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. Has serum creatinine below the upper limit of normal at Visit 1 and an estimated glomerular filtration rate (eGFR) of ≥90 mL/min/1.73 m2 based on the Modification of Diet in Renal Disease (MDRD) equation: eGFR (mL/min/1.73 m2) = 175 x (Scr, std)-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if African American).
  5. Has a fasting glucose concentration of <280 mg/dL at Visit 1.
  6. Has 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. Is male, or is female and meets 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 practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as implants, injectables, hormonal contraceptives, intrauterine contraceptive devices (IUD), sexual abstinence, tubal ligation or occlusion, condom with spermicide or a vasectomized partner) during the entire duration of the study.
  8. Has a physical examination and ECG with no clinically significant abnormalities as judged by the investigator at Visit 1.
  9. Has 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 is not treated with or has 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, has a serum thyroid-stimulating hormone (TSH) test result within the normal range at Visit 1.
  12. Is willing and able to follow study procedures.
  13. Is able to read, understand, and sign the Informed Consent Form (ICF) and an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), answer the study questions, communicate with the investigator, and understand and comply with protocol requirements.

Exclusion Criteria:

  1. Has 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 type 2 diabetes mellitus
    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. Has known hypersensitivity, intolerability, or allergies to metformin HCl or any component of study treatment.
  4. Has physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study.
  5. Currently abuses drugs or alcohol or has 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 is planning to donate blood during the study, or had a significant blood loss within 2 months prior to Visit 1.
  7. Has been treated, is currently being treated, or is 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. Has received or plans to receive any iodinated contrast dye within 1 week prior to Visit 1 (Screening).
  8. Has 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. Has received any investigational drug within 30 days (or five half-lives of the investigational drug, whichever is greater) of Visit 1.
  11. Is 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 is directly affiliated with the study at the clinical study site.
  12. Is 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 ClinicalTrials.gov identifier: NCT01819272

  Show 48 Study Locations
Sponsors and Collaborators
Elcelyx Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Elcelyx Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01819272     History of Changes
Other Study ID Numbers: LCRM105
Study First Received: March 19, 2013
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014