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
  Purpose

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
Placebo

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01554618

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01554618     History of Changes
Other Study ID Numbers: BCB114
Study First Received: March 13, 2012
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration
Ukraine: Ministry of Health
Mexico: Ministry of Health

Keywords provided by AstraZeneca:
exenatide
diabetes
GLP-1 receptor agonist

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

ClinicalTrials.gov processed this record on September 29, 2014