Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes

This study is currently recruiting participants.
Verified March 2012 by Amylin Pharmaceuticals, LLC.
Sponsor:
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01554618
First received: March 13, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted

March 13, 2012
March 13, 2012
November 2011
January 2017   (final data collection date for primary outcome measure)
Change in HbA1c from Baseline [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
14 week placebo-controlled assessment
Same as current
No Changes Posted
  • Changes in fasting plasma glucose [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    14 week placebo-controlled assessment
  • Changes in body weight [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    14 week placebo-controlled assessment
  • Changes in lipids [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    14 week placebo-controlled assessment
  • Changes in blood pressure [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
    14 week placebo-controlled assessment
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes
A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Assess the Safety and Efficacy of Exenatide Once Weekly in Adolescents With Type 2 Diabetes

The study examines the Safety and efficacy study of exenatide once weekly in adolescents with type 2 diabetes.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Adolescent Type 2 Diabetes
  • Drug: Exenatide Once Weekly
    2 mg exenatide once weekly
    Other Name: BYDUREON
  • Drug: Placebo
    Placebo
  • Experimental: EQW
    Exenatide once weekly
    Intervention: Drug: Exenatide Once Weekly
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2017
January 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HbA1c 6.5-11%
  • 10-17 years old
  • diagnosed type 2 diabetes treated with diet/exercise +/- metformin

Exclusion Criteria:

  • Type 1 diabetes
  • chronic insulin use
  • has ever used a GLP-1 receptor agonist (e.g. BYETTA, BYDUREON, or VICTOZA).
Both
10 Years to 17 Years
No
Not Provided
Mexico,   Ukraine
 
NCT01554618
BCB114
Yes
Amylin Pharmaceuticals, LLC.
Amylin Pharmaceuticals, LLC.
Not Provided
Study Director: Senior Vice President Research and Development, M.D. Amylin Pharmaceuticals, LLC.
Amylin Pharmaceuticals, LLC.
March 2012

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