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Extension Study for 2993-112

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01789957
First received: February 11, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: AC2993
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Exenatide
U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, LLC.:

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.


Enrollment: 225
Study Start Date: September 2002
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-label AC2993 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

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789957

  Show 226 Study Locations
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
  More Information

No publications provided

Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT01789957     History of Changes
Other Study ID Numbers: 2993-112E
Study First Received: February 11, 2013
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013