Study Assessing the PK of EFB0027 (Metformin Delayed-release) and Effect on Circulating Glucose and GI Hormone Concentrations in Subjects With T2DM

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elcelyx Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01677299
First received: August 23, 2012
Last updated: May 15, 2014
Last verified: May 2014

August 23, 2012
May 15, 2014
May 2012
September 2012   (final data collection date for primary outcome measure)
  • Area Under the Curve (0-t) of Plasma Metformin [ Time Frame: pre-dose to 11 hours post-dose ] [ Designated as safety issue: No ]
    Area Under the Curve (0-t) of Plasma Metformin
  • Change in Fasting Plasma Glucose [ Time Frame: Change from Baseline (Day 1) to Day 5 ] [ Designated as safety issue: No ]
    LS mean difference from Baseline (Day 1) to Day 5
  • Within Treatment Comparison Based on Ratios of AUCs of GLP-1 [ Time Frame: Ratio of Day 5 to Baseline ] [ Designated as safety issue: No ]
  • Within Treatment Comparison Based on Ratios of AUCs of PYY [ Time Frame: Ratio of Day 5 to Baseline ] [ Designated as safety issue: No ]
Concentration of EFB0026 and EFB0027, measured in ng/mL [ Time Frame: -5, 15, 30, 60, 90, 120, 150, 180, 240, 360, 480,600, and 660 min relative to the start time of the standardized breakfast at Visits 3, 5, 7, and 9 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01677299 on ClinicalTrials.gov Archive Site
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Study Assessing the PK of EFB0027 (Metformin Delayed-release) and Effect on Circulating Glucose and GI Hormone Concentrations in Subjects With T2DM
A RANDOMIZED, CROSSOVER STUDY ASSESSING THE EFFECTS OF PH 6.5 ENTERIC COATING OF METFORMIN HCL TABLETS ON PHARMACOKINETICS AND CHANGES IN CIRCULATING GLUCOSE AND GASTROINTESTINAL HORMONE CONCENTRATIONS IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS

This study will evaluate how EFB0027 and EFB0026 behave in subjects with type 2 diabetes mellitus.

In addition, this study will compare the effects of EFB0027 and EFB0026 on circulating concentrations of glucose and gastrointestinal hormones in subjects with type 2 diabetes mellitus.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • Drug: EFB0027 (metformin delayed release)
    Comparison of enteric-coating to assess effect on PK
    Other Name: Met DR
  • Drug: EFB0026 (metformin immediate-release)
    Active comparator
    Other Names:
    • Met IR
    • metformin
    • Glucophage
  • Active Comparator: 1000 mg EFB0026 (metformin immediate-release)
    BID
    Intervention: Drug: EFB0026 (metformin immediate-release)
  • Experimental: 1000 mg EFB0027 (metformin delayed-release)
    BID
    Intervention: Drug: EFB0027 (metformin delayed release)
  • Experimental: 500 mg EFB0027 (metformin delayed-release)
    BID
    Intervention: Drug: EFB0027 (metformin delayed release)
  • Experimental: 500 mg EFB0026 + 1000 mg EFB0027
    BID
    Interventions:
    • Drug: EFB0027 (metformin delayed release)
    • Drug: EFB0026 (metformin immediate-release)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Is 19 to 70 (inclusive) years old at Visit 1 (Screening).
  2. Is diagnosed with Type 2 Diabetes Mellitus with

    • HbA1c between 6.0 to 9.5% (inclusive) for subjects managing their diabetes with:

      i. Diet and exercise alone, or ii. A stable regimen (minimum of 2 months at Visit 1) of metformin alone, or iii. A stable regimen (minimum of 2 months at Visit 1) of DPP-4 inhibitor alone, OR

    • HbA1c between 6.0 to 8.5% (inclusive) for subjects managing their diabetes with a stable (minimum of 2 months at Visit 1) combination regimen of metformin and DPP-4 inhibitors.
  3. Has serum creatinine below the upper limit of normal at Visit 1 and an estimated creatinine clearance above 80 using the Crockroft and Gault equation (CrCl = [(140 - age) x body weight in kg] / (serum creatinine x 72) x (0.85 for females) [ref. 3].
  4. Has a body mass index (BMI) of 25.0 to 40.0 kg/m2 (inclusive) at Screening.
  5. Is male, or is female and meets all of the following criteria:

    • Not breastfeeding
    • Negative pregnancy test result (human chorionic gonadotropin, beta subunit) at Visit 1 (Screening) (not applicable to hysterectomized females)
    • Surgically sterile, postmenopausal, or if of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study
  6. Has a physical examination with no clinically significant abnormalities as judged by the investigator.
  7. Ability to understand and willingness to adhere to protocol requirements.
  8. If on chronic thyroid pharmacologic therapy, the dose must be stable for at least 3 months prior to Visit 1 (Screening), and must have thyroid-stimulating hormone (TSH) test result in normal range at Visit 1 (Screening).

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:

    • Hepatic disease
    • Renal disease
    • Gastrointestinal disease
    • Endocrine disorder except diabetes
    • Cardiovascular disease
    • Seizure disorder
    • Organ transplantation
    • Chronic infection
  2. Has any chronic disease requiring medication that has been adjusted in the past 90 days (subjects may take acute intermittent over-the-counter medications such as Tylenol, if needed).
  3. Has any drug treatment that affects gastric pH (prescription or over-the-counter), including any antacids or medications such as Rolaids or Pepcid within 2 days of Visit 1 (Screening).
  4. Has had major surgery of any kind within 6 months of Visit 1 (Screening).
  5. Has received a blood transfusion within 6 months of Visit 1 (Screening).
  6. Has a history of >5 kg weight change within 3 months of Visit 1 (Screening).
  7. Has clinical laboratory test (clinical chemistry, hematology, or urinalysis) abnormalities other than those expected in subjects with diabetes and judged by the investigator to be clinically significant at Visit 1 (Screening).
  8. Has physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study.
  9. 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.
  10. Has donated blood within 2 months of Visit 1 (Screening) or is planning to donate blood during the study.
  11. Has used insulin within 3 months of Visit 1 (Screening).
  12. Has received GLP-1 receptor agonists and/or thiazolidinedione treatment within 6 months of Visit 1 (Screening).
  13. Has known intolerance to metformin.
  14. Has received any investigational drug within 1 month (or five half-lives of the investigational drug, whichever is greater) of Visit 1 (Screening).
  15. Has known allergies or hypersensitivity to any component of study treatment.
  16. Is employed by Elcelyx Therapeutics, Inc (that is an employee, temporary contract worker, or designee of the company).
  17. Smokes more than 10 cigarettes per day, 2 cigars per day, or uses more than 1 can of smokeless tobacco per week.
Both
19 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01677299
LCPOC10
No
Elcelyx Therapeutics, Inc.
Elcelyx Therapeutics, Inc.
Not Provided
Not Provided
Elcelyx Therapeutics, Inc.
May 2014

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