Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes

This study is currently recruiting participants.
Verified July 2012 by Amylin Pharmaceuticals, LLC.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00658021
First received: April 8, 2008
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

The primary objective of this study is to test the hypothesis that glycemic control, as measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2 diabetes who are naïve to antidiabetic agents(with diet and exercise) or who are being treated with Met, SU, or a combination of Met and SU (with or without diet and exercise).


Condition Intervention Phase
Type 2 Diabetes
Drug: placebo
Drug: exenatide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Amylin Pharmaceuticals, LLC.:

Primary Outcome Measures:
  • The primary objective of this study is to test the hypothesis that glycemic control with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exenatide 5 µg BID vs. Exenatide 10 µg BID vs. placebo to compare: • the proportion of patients achieving an HbA1c at endpoint of ≤7%, <7%, ≤6.5% and <6.5% • body weight • fasting serum glucose • self-monitored blood glucose [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Safety Follow-up: Observation of ongoing development and growth [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Long-term follow-up of patients will allow observation of ongoing development and growth on an individual patient basis and a description of the occurrence of selected adverse events (AEs) in pediatric patients in the absence of study drug treatment following up to 28 weeks of study drug administration.


Estimated Enrollment: 195
Study Start Date: May 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo
subcutaneous injection, twice a day
Active Comparator: 2 Drug: exenatide
subcutaneous injection, twice a day, 10 mcg
Active Comparator: 3 Drug: exenatide
subcutaneous injection, twice a day, 5 mcg

  Eligibility

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

Inclusion Criteria:

  • Are between ages 10 to 17 years, inclusive.
  • Have a history of type 2 diabetes.
  • Have no antibodies to glutamic decarboxylase (GAD65) or islet cell (ICA512).
  • Have been treated with Met, an SU, or both Met and SU (with or without diet and exercise), for at least 3 months or are naïve to antidiabetic agents (with diet and exercise). The dose of oral agent(s) should be stable for the 30 days prior to the screening visit.
  • Have HbA1c between 6.5% and 10.5%, inclusive.
  • Present an appropriately signed assent form.
  • A parent or adult guardian agrees in writing to participate in the patient's treatment by signing a consent form.
  • Both the patient and parent or responsible adult guardian are able to understand and comply with a lifestyle modification program.

Exclusion Criteria:

  • Received any investigational drug or has participated in any type of clinical trial within 60 days prior to screening.
  • Have previously been exposed to exenatide or, completed or withdrawn from any study investigating exenatide.
  • Are unwilling or unable to inject the study medication.
  • Have a genetic syndrome or disorder other than diabetes known to affect glucose tolerance.
  • Have used an alpha-glucosidase inhibitor, a meglitinide, or pramlintide for more than 1 week during the 3 months prior to screening.
  • Currently use inhaled steroids at a dose equal to or above 1000 μg Flovent® (fluticasone propionate) daily.
  • Have used oral steroids within the last 60 days or more than 20 days use within the past year.
  • Have used a TZD within 120 days prior to screening.
  • Have used any weight loss medication(s) within 30 days of screening.
  • Are sexually active female of childbearing potential who is unwilling to appropriately use TWO methods of birth control (for example, use of oral contraceptives; condoms with contraceptive foam; or abstinence) for the duration of the study.
  • Are female who is pregnant or planning to become pregnant within 6 months of study screening.
  • Are female who is lactating.
  • Have had at least one episode of diabetic ketoacidosis (DKA) after receiving antidiabetes medication. A history of DKA at the time of diagnosis will not be an exclusion criterion.
  • Have physical limitations that prevent participation in lifestyle intervention.
  • Have admitted use of anabolic steroids within the past 60 days.
  • Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than in situ carcinomas of the cervix) for less than 5 years.
  • Have used insulin for more than 10 weeks during the 3 months prior to screening.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658021

Contacts
Contact: Lilly Clinical Trials Support Center 1-877-CTLILLY (1-877-285-4559)

  Hide Study Locations
Locations
United States, Alabama
Research Site Recruiting
Birmingham, Alabama, United States
Contact: Lilly Clinical Trials Support Center    877-285-4559      
United States, Arizona
Research Site Withdrawn
Phoenix, Arizona, United States
Research Site Recruiting
Tucson, Arizona, United States
Contact: Lilly Clinical Trials Support Center    877-285-4559      
United States, California
Research Site Withdrawn
Los Angeles, California, United States
Research Site Terminated
Sacramento, California, United States
Research Site Recruiting
San Diego, California, United States
Contact: Lilly Clinical Trials Support Center    877-285-4559      
Research Site Withdrawn
Santa Ana, California, United States
United States, Colorado
Research Site Recruiting
Aurora, Colorado, United States
Contact: Lilly Clinical Trials Support Center    877-285-4559      
United States, Florida
Research Site Terminated
Melbourne, Florida, United States
Research Site Terminated
Orlando, Florida, United States
Research Site Withdrawn
Palm Bay, Florida, United States
Research Site Terminated
Pensacola, Florida, United States
Research Site Terminated
Tallahassee, Florida, United States
United States, Georgia
Research Site Withdrawn
Atlanta, Georgia, United States
Research Site Terminated
Dalton, Georgia, United States
United States, Hawaii
Research Site Withdrawn
Honolulu, Hawaii, United States
United States, Illinois
Research Site Terminated
Chicago, Illinois, United States
United States, Indiana
Research Site Recruiting
Indianapolis, Indiana, United States
Contact: Lilly Clinical Trials Support Center    877-285-4559      
United States, Kansas
Research Site Withdrawn
Topeka, Kansas, United States
Research Site Recruiting
Wichita, Kansas, United States
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United States, Michigan
Research Site Withdrawn
Ann Arbor, Michigan, United States
Research Site Recruiting
Dearborn, Michigan, United States
Contact: Lilly Clinical Trials Support Center    877-285-4559      
United States, Minnesota
Research Site Active, not recruiting
St. Paul, Minnesota, United States, 55102
United States, Missouri
Research Site Withdrawn
St. Louis, Missouri, United States
United States, Nevada
Research Site Terminated
Reno, Nevada, United States
United States, New York
Research Site Recruiting
Mineola, New York, United States, 11501
Contact: Lilly Clinical Trials Support Center    877-285-4559      
Research Site Withdrawn
New York, New York, United States
United States, North Carolina
Research Site Withdrawn
Chapel Hill, North Carolina, United States
Research Site Terminated
Greenville, North Carolina, United States
Research Site Withdrawn
Raleigh, North Carolina, United States
United States, Ohio
Research Site Withdrawn
Toledo, Ohio, United States
United States, Oklahoma
Research Site Withdrawn
Oklahoma City, Oklahoma, United States
United States, Oregon
Research Site Withdrawn
Portland, Oregon, United States
United States, Pennsylvania
Research Site Withdrawn
Philadelphia, Pennsylvania, United States
Research Site Withdrawn
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Research Site Withdrawn
Columbia, South Carolina, United States
United States, Tennessee
Research Site Withdrawn
Chattanooga, Tennessee, United States
Research Site Recruiting
Memphis, Tennessee, United States
Contact: Lilly Clinical Trials Support Center    877-285-4559      
Research Site Withdrawn
Nashville, Tennessee, United States
United States, Texas
Research Site Withdrawn
Austin, Texas, United States
Research Site Recruiting
Dallas, Texas, United States
Contact: Lilly Clinical Trials Support Center    877-285-4559      
Research Site Terminated
San Antonio, Texas, United States
United States, Washington
Research Site Terminated
Spokane, Washington, United States
India
Research Site Recruiting
Gujarat, India
Contact: Lilly Clinical Trials Support Center    877-285-4559      
Research Site Recruiting
Karnataka, India
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Research Site Recruiting
Maharashtra, India
Contact: Lilly Clinical Trials Support Center    877-285-4559      
Research Site Withdrawn
West Bengal, India
Korea, Republic of
Research Site Withdrawn
Gyeonggi-do, Korea, Republic of
Research Site Terminated
Seoul, Korea, Republic of
Mexico
Research Site Recruiting
Puebla, Mexico
Contact: Lilly Clinical Trials Support Center    877-285-4559      
Research Site Recruiting
Tamaulipas, Mexico
Contact: Lilly Clinical Trials Support Center    877-285-4559      
Puerto Rico
Research Site Withdrawn
Rio Piedras, Puerto Rico
Research Site Withdrawn
San German, Puerto Rico
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
Study Director: Chief Medical Officer, MD Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT00658021     History of Changes
Other Study ID Numbers: H8O-MC-GWBQ
Study First Received: April 8, 2008
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, LLC.:
diabetes
adolescents
exenatide
Amylin
Lilly

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 April 16, 2014