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: December 5, 2014

Last verified: December 2014

History of Changes

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:

MedlinePlus related topics: Diabetes Type 2

Drug Information available for: Exenatide

U.S. FDA Resources

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:	December 5, 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 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Exenatide	Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Hypoglycemic Agents Incretins Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 01, 2015

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