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. (see Contacts and Locations)
Verified October 2014 by AstraZeneca
Sponsor:
Collaborator:
inVentiv Health Clinical
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00658021
First received: April 8, 2008
Last updated: October 22, 2014
Last verified: October 2014
  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 antidiabetes agents, or patients who are being treated with metformin, an SU, or a combination of metformin and an SU.


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 AstraZeneca:

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 ]
  • The primary endpoint is change in A1c from baseline compared to placebo. [ Time Frame: 28 weeks ]

Secondary Outcome Measures:
  • The secondary objectives of the study are to evaluate the difference between exenatide and placebo with respect to glycemic, weight, and safety assessments. [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Proportion of patient achieving an HbA1c at endpoint of <7%, ≤6.5%, and <6.5 %. [ Time Frame: 28 weeks ]
    The efficacy measures (both actual and change values) will be summarized at baseline, endpoint, and, if measured, at each visit.

  • Body weight [ Time Frame: 28 weeks ]
    The efficacy measures (both actual and change values) will be summarized at baseline, endpoint, and, if measured, at each visit.

  • Fasting serum glucose [ Time Frame: 28 weeks ]
    The efficacy measures (both actual and change values) will be summarized at baseline, endpoint, and, if measured, at each visit.

  • Self-monitored blood glucose [ Time Frame: 28 weeks ]
    The efficacy measures (both actual and change values) will be summarized at baseline, endpoint, and, if measured, at each visit.

  • Fasting serum insulin concentrations [ Time Frame: 28 weeks ]
    The efficacy measures (both actual and change values) will be summarized at baseline, endpoint, and, if measured, at each visit.

  • Beta-cell function and insulin sensitivity as measured by homeostasis model assessment (HOMA-B, HOMA-S) [ Time Frame: 28 weeks ]
    The efficacy measures (both actual and change values) will be summarized at baseline, endpoint, and, if measured, at each visit.

  • Proportion of patients who discontinue the study due to failure to maintain glycemic control. [ Time Frame: 28 weeks ]
    The efficacy measures (both actual and change values) will be summarized at baseline, endpoint, and, if measured, at each visit.


Estimated Enrollment: 195
Study Start Date: May 2008
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subcutaneous injection, twice a day
Drug: Placebo
Subcutaneous injection, twice a day
Experimental: Exenatide 5 µg
Subcutaneous injection, twice a day
Drug: Exenatide
Subcutaneous injection, 5 µg, twice a day
Experimental: Exenatide 10 µg
Subcutaneous injection, twice a day
Drug: Exenatide
Subcutaneous injection,10 µg, twice a day

  Eligibility

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

Inclusion Criteria-patients are eligible to be included in the study only if they meet all of the following criteria:

  • are a male or a female between ages 10 to 17 years, inclusive. The number of patients ≥17 years of age will be limited to no more than 10% of patients in each treatment arm
  • have a history of type 2 diabetes with the original diagnosis based on at least one American Diabetes Association (ADA) diagnostic criteria
  • have been treated with metformin, an SU, or both metformin and an SU (with or without diet and exercise), for at least 3 months or are naïve to anti-diabetes agents and being treated with diet and exercise alone. The dose of oral agent(s) should be stable for the 30 days prior to the screening visit
  • have fasting C-peptide >0.6 ng/mL
  • have HbA1c between 6.5% and 10.5%, inclusive.

Disease Diagnostic Criteria-for the purposes of this study, patients with type 2 diabetes are defined by:

  • diagnosis of type 2 diabetes, as determined by ADA diagnostic criteria and antibody testing, documented and confirmed in the patient's medical record, which includes laboratory determinations consistent with one or more of the following in the patient's medical history
  • fasting blood glucose 126 mg/dL (7.0 mmol/L)
  • random blood glucose 200 mg/dL (11.1 mmol/L)
  • two-hour OGTT (Oral Glucose Tolerance Test) ≥ 200 mg/dL (11.1 mmol/L) AND one or more of the following: no antibodies to GAD65 OR no antibodies to islet cell antigen (ICA512).

Exclusion Criteria-patients will be excluded from the study if they meet any of the following criteria:

  • have previously been exposed to exenatide or, completed or withdrawn from this study or any other study investigating exenatide
  • are unwilling or unable to inject the study medication
  • currently use inhaled steroids at a dose equal to or above 1000g 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 any weight loss medication(s) within 30 days of screening
  • have used insulin for more than 10 weeks during the 3 months prior to screening
  • have history of renal disease, or serum creatinine >1.6 mg/dL (141.4 µmol/L) (males) or >1.4 mg/dL (123.8 µmol/L) (females)
  • have hepatic dysfunction, defined by aspartate (AST) or alanine (ALT) transaminase >3.0 times the upper limit of normal (ULN).
  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: NCT00658021

Contacts
Contact: Peter Öhman ClinicalTrialTransparency@astrazeneca.com

  Hide Study Locations
Locations
United States, Alabama
Research Site Recruiting
Birmingham, Alabama, United States
United States, Arizona
Research Site Completed
Tucson, Arizona, United States
United States, California
Research Site Completed
Los Angeles, California, United States
Research Site Completed
Sacramento, California, United States
Research Site Recruiting
San Diego, California, United States
Research Site Completed
Santa Ana, California, United States
United States, Colorado
Research Site Completed
Aurora, Colorado, United States
United States, Florida
Research Site Completed
Melbourne, Florida, United States
Research Site Completed
Orlando, Florida, United States
Research Site Completed
Pensacola, Florida, United States
Research Site Completed
Tallahassee, Florida, United States
United States, Georgia
Research Site Completed
Dalton, Georgia, United States
United States, Hawaii
Research Site Withdrawn
Honolulu, Hawaii, United States
United States, Illinois
Research Site Completed
Chicago, Illinois, United States
United States, Indiana
Research Site Completed
Indianapolis, Indiana, United States
United States, Kansas
Research Site Completed
Wichita, Kansas, United States
United States, Michigan
Research Site Completed
Dearborn, Michigan, United States
United States, Minnesota
Research Site Recruiting
St. Paul, Minnesota, United States
United States, Missouri
Research Site Completed
St. Louis, Missouri, United States
United States, Nevada
Research Site Completed
Reno, Nevada, United States
United States, New York
Research Site Recruiting
Mineola, New York, United States
United States, North Carolina
Research Site Completed
Greenville, North Carolina, United States
Research Site Completed
Raleigh, North Carolina, United States
United States, Oklahoma
Research Site Completed
Oklahoma City, Oklahoma, United States
United States, Tennessee
Research Site Recruiting
Memphis, Tennessee, United States
United States, Texas
Research Site Completed
Dallas, Texas, United States
Research Site Withdrawn
San Antonio, Texas, United States
Research Site Completed
San Antonio, Texas, United States
United States, Washington
Research Site Completed
Spokane, Washington, United States
India
Research Site Completed
Ahmedabad, India
Research Site Completed
Bangalore, India
Research Site Completed
Pune, India
Korea, Republic of
Research Site Completed
Seoul, Korea, Republic of
Mexico
Research Site Recruiting
Monterrey, Mexico
Research Site Recruiting
Puebla, Mexico
Research Site Completed
Tamaupilas, Mexico
Research Site Completed
Tampico, Mexico
Sponsors and Collaborators
AstraZeneca
inVentiv Health Clinical
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00658021     History of Changes
Other Study ID Numbers: D5550C00002
Study First Received: April 8, 2008
Last Updated: October 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
diabetes
adolescents
exenatide
Astra Zeneca

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

ClinicalTrials.gov processed this record on October 30, 2014