Extension Study for 2993-112

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01789957
First received: February 11, 2013
Last updated: October 9, 2013
Last verified: October 2013

February 11, 2013
October 9, 2013
September 2002
June 2004   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01789957 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Extension Study for 2993-112
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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: 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
Experimental: Open-label AC2993
Intervention: Drug: AC2993
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
June 2004
June 2004   (final data collection date for primary outcome measure)

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.
Both
16 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01789957
2993-112E
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
October 2013

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