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Assessing the Effect of Met DR on Plasma Glucose and PK in Subjects With T2DM

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ClinicalTrials.gov Identifier: NCT01804842
Recruitment Status : Completed
First Posted : March 5, 2013
Results First Posted : April 7, 2016
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Elcelyx Therapeutics, Inc.

Brief Summary:
This study compared the effects of delayed-release metformin (Met DR, EFB0027) administered once daily in the morning (qAM), administered once daily in the evening (qPM), and administered twice daily (BID) on circulating glucose concentrations and metformin pharmacokinetics (PK) in subjects with type 2 diabetes mellitus (T2DM).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Met DR Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized, Crossover Study Assessing the Effect of EFB0027 on Plasma Glucose and Pharmacokinetics in Subjects With Type 2 Diabetes Mellitus
Study Start Date : December 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 500 mg Met DR BID
Two doses of 500 mg metformin delayed-release
Drug: Met DR
metformin delayed-release tablets
Other Name: EFB0027

Experimental: 1000 mg Met DR qAM
One dose of 1000 mg metformin delayed-release in the morning
Drug: Met DR
metformin delayed-release tablets
Other Name: EFB0027

Experimental: 1000 mg Met DR qPM
One dose of 1000 mg metformin delayed-release in the evening
Drug: Met DR
metformin delayed-release tablets
Other Name: EFB0027




Primary Outcome Measures :
  1. AUC (0-24) of Plasma Metformin [ Time Frame: Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner. ]
    AUC (0-24) = Area under the curve from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.

  2. Cmax of Plasma Metformin [ Time Frame: Times points to determine Cmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner. ]
    Cmax = maximum response from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.

  3. AUC (0-24) of Plasma Glucose [ Time Frame: Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the time of the standardized dinner. ]
    AUC (0-24) = Area under the curve from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.

  4. Rmax (0-24) of Plasma Glucose [ Time Frame: Times points to determine Rmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner. ]
    Rmax (0-24) = maximum response from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 to 70 (inclusive) years old at Visit 1 (Screening)
  2. Was 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. Had normal renal function with an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73 m^2 based on the Modification of Diet in Renal Disease (MDRD) equation
  4. Body mass index (BMI) of 25.0 to 40.0 kg/m^2 (inclusive) at Screening
  5. Male, or if female and met 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, practiced and was willing to continue to practice appropriate birth control during the entire duration of the study
  6. Had 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 have been 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. 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
    • Renal disease
    • Gastrointestinal disease
    • Endocrine disorder except diabetes
    • 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
  2. Had any chronic disease requiring medication that was adjusted in the past 90 days (subjects could take acute intermittent over-the-counter medications such as Tylenol, if needed)
  3. Had 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. Had major surgery of any kind within 6 months of Visit 1 (Screening)
  5. Had received a blood transfusion within 6 months of Visit 1 (Screening)
  6. Had a history of >5 kg weight change within 3 months of Visit 1 (Screening)
  7. Had clinical laboratory test (clinical chemistry, hematology, or urinalysis) abnormalities other than those expected in subjects with type 2 diabetes and judged by the investigator to be clinically significant at Visit 1 (Screening)
  8. Had a physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study
  9. 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
  10. Had donated blood within 3 months of the date of the first dose of randomized study medication, or was planning to donate blood during the study
  11. Used insulin within 3 months of Visit 1 (Screening)
  12. Had received GLP-1 receptor agonists and/or thiazolidinedione treatment within 6 months of Visit 1 (Screening)
  13. Had known intolerance to metformin
  14. Had received any investigational drug within 2 months (or five half-lives of the investigational drug, whichever was greater) of Visit 1 (Screening)
  15. Had known allergies or hypersensitivity to any component of study treatment
  16. Was employed by Elcelyx Therapeutics, Inc. (that is an employee, temporary contract worker, or designee of the company)
  17. Smoked more than 10 cigarettes per day, 3 cigars per day, 3 pipes per day, used more than 1 can of smokeless tobacco per week, or used a combination of tobacco products that approximate nicotine doses equivalent to 10 cigarettes per day

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 ClinicalTrials.gov identifier (NCT number): NCT01804842


Sponsors and Collaborators
Elcelyx Therapeutics, Inc.
Investigators
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Principal Investigator: Danielle Armas, MD Celerion

Publications:
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Responsible Party: Elcelyx Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01804842     History of Changes
Other Study ID Numbers: LCRM104
First Posted: March 5, 2013    Key Record Dates
Results First Posted: April 7, 2016
Last Update Posted: October 21, 2016
Last Verified: October 2016

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