Extension Study for 2993-112
This study has been completed.
Information provided by (Responsible Party):
First received: February 11, 2013
Last updated: February 23, 2015
Last verified: January 2015
This multicenter, open-label extension study of Protocol 2993-112 is designed to assess long-term glucose control as measured by HbA1c (glycosylated hemoglobin) and to evaluate long-term safety and tolerability in subjects treated with metformin who receive subcutaneously injected AC2993 (10 mcg) administered twice daily. Subjects completing Protocol 2993-112 are eligible to enroll.
Type 2 Diabetes Mellitus
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open-Label Extension Study of Protocol 2993-112 to Examine the Long-Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of AC2993 Given Two Times a Day to Subjects Treated With Metformin Alone
Primary Outcome Measures:
- Change in HbA1c from Day 1 of Protocol 2993-112 to Week 52 (or termination) [ Time Frame: Day 1 of study 2993-112 through extension study termination (up to Week 52) ] [ Designated as safety issue: No ]
Change in HbA1c from Visit 3 (Day 1) of Protocol 2993-112 to Visit 6E (Week 52) of the extension study and to each intermediate visit in the extension study will be calculated and summarized descriptively.
- Change in body weight from Day 1 of Protocol 2993-112 to Week 52 (or termination) [ Time Frame: Day 1 of study 2993-112 through extension study termination (up to Week 52) ] [ Designated as safety issue: No ]
Change in body weight (KG) from Visit 3 (Day 1) of Protocol 2993-112 to Visit 6E (Week 52) of the extension study and to each intermediate visit in the extension study will be calculated and summarized descriptively.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2004 (Final data collection date for primary outcome measure)
Experimental: Open-label AC2993
4-Week transition of AC2993 5 mcg subcutaneously injected twice daily followed by an open-ended period through study termination (up to 52 weeks) of AC2993 10 mcg subcutaneously injected twice daily
Other Name: Exenatide
|Ages Eligible for Study:
||16 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
All of the following criteria are to be fulfilled for inclusion of an individual in the study unless the sponsor grants an exception:
- Has completed the 30-week triple-blind treatment initiation/active treatment periods in Protocol 2993-112, including all procedures required at the study termination visit (Week 30).
- Male or female. Female individuals must be either 1) postmenopausal as documented by serum FSH measurement unless using estrogen for hormone replacement therapy; or 2) of childbearing potential and used appropriate contraceptive methods (surgical sterility or oral, injected, barrier, intrauterine, or implanted contraceptives) for the duration of Protocol 2993-112. This individual must have a current, negative pregnancy test (human chorionic gonadotropin [HCG], beta subunit) regardless of birth control method used. The individual agrees to continue using birth control throughout the study to prevent pregnancy.
- Able to understand and sign a Protocol 2993-112E-specific informed consent form, communicate with the investigator, and understand and comply with the protocol requirements.
Individuals meeting any of the following criteria are to be excluded from the study unless the sponsor grants an exception:
- Has not completed Protocol 2993-112.
- Female individuals who are pregnant, lactating, or planning to become pregnant.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01789957
No publications provided
ClinicalTrials.gov processed this record on March 25, 2015
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 11, 2013
||February 23, 2015
||United States: Food and Drug Administration