Status:
COMPLETED
Assessing the Effect of Met DR on Plasma Glucose and PK in Subjects With T2DM
Lead Sponsor:
Elcelyx Therapeutics, Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 18 to 70 (inclusive) years old at Visit 1 (Screening)
- 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
- 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
- Body mass index (BMI) of 25.0 to 40.0 kg/m\^2 (inclusive) at Screening
- 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
- Had a physical examination with no clinically significant abnormalities as judged by the investigator
- Ability to understand and willingness to adhere to protocol requirements
- 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
- 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
- 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)
- 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)
- Had major surgery of any kind within 6 months of Visit 1 (Screening)
- Had received a blood transfusion within 6 months of Visit 1 (Screening)
- Had a history of \>5 kg weight change within 3 months of Visit 1 (Screening)
- 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)
- Had a physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study
- 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
- 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
- Used insulin within 3 months of Visit 1 (Screening)
- Had received GLP-1 receptor agonists and/or thiazolidinedione treatment within 6 months of Visit 1 (Screening)
- Had known intolerance to metformin
- Had received any investigational drug within 2 months (or five half-lives of the investigational drug, whichever was greater) of Visit 1 (Screening)
- Had known allergies or hypersensitivity to any component of study treatment
- Was employed by Elcelyx Therapeutics, Inc. (that is an employee, temporary contract worker, or designee of the company)
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01804842
Start Date
December 1 2012
End Date
April 1 2013
Last Update
October 21 2016
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.