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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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 Amylin Pharmaceuticals, LLC.:

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 Not yet recruiting
Guadalajara, Jalisco, Mexico
Contact: Amylin Call Center    866-208-1661      
Research Site Not yet recruiting
Morelia, Michoacan, Mexico
Contact: Amylin Call Center    866-208-1661      
Research Site Not yet recruiting
Culiacan, Sinaloa, Mexico
Contact: Amylin Call Center    866-208-1661      
Reserach Site Not yet recruiting
Mexico City, Mexico
Contact: Amylin Call Center    866-208-1661      
Ukraine
Research Site Recruiting
Chernivtsi, Ukraine
Contact: Amylin Call Center    866-208-1661      
Research Site Recruiting
Donetsk, Ukraine
Contact: Amylin Call Center    866-208-1661      
Research Site Recruiting
Kiev, Ukraine
Contact: Amylin Call Center    866-208-1661      
Research Site Recruiting
Poltava, Ukraine
Contact: Amylin Call Center    866-208-1661      
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Investigators
Study Director: Senior Vice President Research and Development, M.D. Amylin Pharmaceuticals, LLC.
  More Information

No publications provided

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

Keywords provided by Amylin Pharmaceuticals, LLC.:
exenatide
diabetes
GLP-1 receptor agonist

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 July 29, 2014