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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01554618
First received: March 13, 2012
Last updated: August 14, 2014
Last verified: August 2014

March 13, 2012
August 14, 2014
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
Complete list of historical versions of study NCT01554618 on ClinicalTrials.gov Archive Site
  • 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.
 
Suspended
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
Contact information is only displayed when the study is recruiting subjects
Mexico,   Ukraine
 
NCT01554618
BCB114
Yes
AstraZeneca
AstraZeneca
Not Provided
Study Director: Senior Vice President Research and Development, M.D. Amylin Pharmaceuticals, LLC.
AstraZeneca
August 2014

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