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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

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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: EFB0027 (metformin delayed release)
Drug: EFB0026 (metformin immediate-release)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: May 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1000 mg EFB0026 (metformin immediate-release)
BID
Drug: EFB0026 (metformin immediate-release)
Active comparator
Other Names:
  • Met IR
  • metformin
  • Glucophage
Experimental: 1000 mg EFB0027 (metformin delayed-release)
BID
Drug: EFB0027 (metformin delayed release)
Comparison of enteric-coating to assess effect on PK
Other Name: Met DR
Experimental: 500 mg EFB0027 (metformin delayed-release)
BID
Drug: EFB0027 (metformin delayed release)
Comparison of enteric-coating to assess effect on PK
Other Name: Met DR
Experimental: 500 mg EFB0026 + 1000 mg EFB0027
BID
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

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01677299

Locations
United States, Arizona
Celerion, Inc.
Tempe, Arizona, United States, 85283
United States, Nebraska
Celerion, Inc.
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Elcelyx Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Elcelyx Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01677299     History of Changes
Other Study ID Numbers: LCPOC10
Study First Received: August 23, 2012
Results First Received: February 12, 2014
Last Updated: May 15, 2014
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 25, 2014