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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

March 19, 2013
May 17, 2013
March 2013
November 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01819272 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
12-Week, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Metformin DR in Subjects With Type 2 Diabetes Mellitus
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: delayed-release metformin
  • Drug: extended-release metformin
  • Experimental: Met DR 600 mg once daily in the morning
    Delayed-release metformin 600 mg QD in the morning
    Intervention: Drug: delayed-release metformin
  • Experimental: Met DR 800 mg QD once daily in the morning
    Delayed-release metformin 800 mg QD in the morning
    Intervention: Drug: delayed-release metformin
  • Experimental: Met DR 1000 mg once daily in the morning
    Delayed-release metformin 1000 mg QD in the morning
    Intervention: Drug: delayed-release metformin
  • Active Comparator: Met XR 1000 mg once daily in the evening
    Extended-release metformin 1000 mg QD in the evening
    Intervention: Drug: extended-release metformin
  • Active Comparator: Met XR 2000 mg once daily in the evening
    Extended-release metformin 2000 mg QD in the evening
    Intervention: Drug: extended-release metformin
  • Placebo Comparator: Placebo once daily in the morning
    Placebo QD in the morning
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
December 2013
November 2013   (final data collection date for primary outcome measure)

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).
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01819272
LCRM105
No
Elcelyx Therapeutics, Inc.
Elcelyx Therapeutics, Inc.
Not Provided
Not Provided
Elcelyx Therapeutics, Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP