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

This study has suspended participant recruitment.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: March 13, 2012
Last updated: March 10, 2015
Last verified: March 2015

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

Condition Intervention Phase
Adolescent Type 2 Diabetes
Drug: Exenatide Once Weekly
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in HbA1c from Baseline [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    14 week placebo-controlled assessment

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EQW
Exenatide once weekly
Drug: Exenatide Once Weekly
2 mg exenatide once weekly
Other Name: BYDUREON
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01554618

Research Site
Guadalajara, Jalisco, Mexico
Research Site
Morelia, Michoacan, Mexico
Research Site
Culiacan, Sinaloa, Mexico
Reserach Site
Mexico City, Mexico
Research Site
Chernivtsi, Ukraine
Research Site
Donetsk, Ukraine
Research Site
Kiev, Ukraine
Research Site
Poltava, Ukraine
Sponsors and Collaborators
Study Director: Senior Vice President Research and Development, M.D. Amylin Pharmaceuticals, LLC.
  More Information

No publications provided

Responsible Party: AstraZeneca Identifier: NCT01554618     History of Changes
Other Study ID Numbers: BCB114, D5551C00002
Study First Received: March 13, 2012
Last Updated: March 10, 2015
Health Authority: United States: Food and Drug Administration
Ukraine: Ministry of Health
Mexico: Ministry of Health

Keywords provided by AstraZeneca:
GLP-1 receptor agonist

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on September 02, 2015