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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 October 2017 by AstraZeneca
Sponsor:
ClinicalTrials.gov Identifier:
NCT00658021
First Posted: April 14, 2008
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
AstraZeneca
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
  • 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 ]
  • 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
Actual Study Start Date: May 30, 2008
Estimated Study Completion Date: May 15, 2020
Estimated Primary Completion Date: August 17, 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658021


Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

  Hide Study Locations
Locations
United States, Alabama
Research Site Recruiting
Birmingham, Alabama, United States, 35233
United States, Arizona
Research Site Completed
Tucson, Arizona, United States, 85724
United States, California
Research Site Completed
Los Angeles, California, United States, 90048
Research Site Recruiting
Montclair, California, United States, 91763
Research Site Completed
Sacramento, California, United States, 95819
Research Site Completed
San Diego, California, United States, 92123
Research Site Completed
Santa Ana, California, United States, 92707
United States, Colorado
Research Site Completed
Aurora, Colorado, United States, 80045
United States, Florida
Research Site Completed
Melbourne, Florida, United States, 32901
Research Site Recruiting
Miami Lakes, Florida, United States, 33014
Research Site Not yet recruiting
Miami, Florida, United States, 33142
Research Site Not yet recruiting
Miami, Florida, United States, 33144
Research Site Recruiting
Miami, Florida, United States, 33144
Research Site Not yet recruiting
Miami, Florida, United States, 33184
Research Site Not yet recruiting
Oakland Park, Florida, United States, 33309
Research Site Completed
Orlando, Florida, United States, 32806
Research Site Completed
Pensacola, Florida, United States, 32504
Research Site Completed
Tallahassee, Florida, United States, 32308
United States, Georgia
Research Site Completed
Dalton, Georgia, United States, 30721
United States, Hawaii
Research Site Withdrawn
Honolulu, Hawaii, United States, 96822
United States, Illinois
Research Site Completed
Chicago, Illinois, United States, 60612
Research Site Completed
Chicago, Illinois, United States, 60637
United States, Indiana
Research Site Completed
Indianapolis, Indiana, United States, 46202
United States, Kansas
Research Site Completed
Wichita, Kansas, United States, 67226
United States, Michigan
Research Site Completed
Dearborn, Michigan, United States, 48124
United States, Minnesota
Research Site Withdrawn
Saint Paul, Minnesota, United States, 55102
United States, Missouri
Research Site Recruiting
Kansas City, Missouri, United States, 64108
Research Site Completed
Saint Louis, Missouri, United States, 63104
United States, Nebraska
Research Site Not yet recruiting
Omaha, Nebraska, United States, 68131
United States, Nevada
Research Site Completed
Reno, Nevada, United States, 89502
United States, New York
Research Site Recruiting
Jamaica, New York, United States, 11432
Research Site Recruiting
Mineola, New York, United States, 11501
Research Site Not yet recruiting
New York, New York, United States, 10029
United States, North Carolina
Research Site Completed
Greenville, North Carolina, United States, 27834
Research Site Completed
Raleigh, North Carolina, United States, 27610
United States, Oklahoma
Research Site Completed
Oklahoma City, Oklahoma, United States, 73104-5008
United States, Tennessee
Research Site Completed
Memphis, Tennessee, United States, 38401
United States, Texas
Research Site Not yet recruiting
Arlington, Texas, United States, 76014
Research Site Recruiting
Dallas, Texas, United States, 75225
Research Site Completed
Dallas, Texas, United States, 75235
Research Site Completed
San Antonio, Texas, United States, 78207
Research Site Withdrawn
San Antonio, Texas, United States, 78229
United States, Utah
Research Site Recruiting
Salt Lake City, Utah, United States, 84107
United States, Washington
Research Site Completed
Spokane, Washington, United States, 99202
Brazil
Research Site Not yet recruiting
Belo Horizonte, Brazil, 30150-221
Research Site Recruiting
Brasília, Brazil, 71625-009
Research Site Not yet recruiting
Campinas, Brazil, 13087-567
Research Site Recruiting
Caxias do Sul, Brazil, 95070-560
Research Site Not yet recruiting
Fortaleza, Brazil, 60430-370
Research Site Recruiting
Goiânia, Brazil, 74110-010
Research Site Recruiting
Juiz de Fora, Brazil, 36025-330
Research Site Not yet recruiting
Porto Alegre, Brazil, 90035-170
Research Site Not yet recruiting
Porto Alegre, Brazil, 91350-250
Research Site Recruiting
Santo André, Brazil, 09030-010
India
Research Site Completed
Ahmedabad, India, 380006
Research Site Not yet recruiting
Bangalore, India, 560060
Research Site Not yet recruiting
Bangalore, India, 560099
Research Site Completed
Bangalore, India
Research Site Not yet recruiting
Chandigarh, India, 160011
Research Site Not yet recruiting
Coimbatore, India, 641009
Research Site Not yet recruiting
Gurgaon, India, 122001
Research Site Not yet recruiting
Kolkata, India, 700094
Research Site Not yet recruiting
Mumbai, India, 400 078
Research Site Not yet recruiting
Mumbai, India, 400016
Research Site Not yet recruiting
New Delhi, India, 110029
Research Site Not yet recruiting
Pune, India, 411004
Research Site Completed
Pune, India
Research Site Not yet recruiting
Vishakhapatnam, India, 530002
Korea, Republic of
Research Site Completed
Seoul, Korea, Republic of
Mexico
Research Site Not yet recruiting
Aguascalientes, Mexico, 20127
Research Site Not yet recruiting
Culiacán, Mexico, 80020
Research Site Not yet recruiting
Culiacán, Mexico, 80200
Research Site Recruiting
Guadalajara, Mexico, 44650
Research Site Not yet recruiting
Mexico, Mexico, 11560
Research Site Recruiting
Monterrey, Mexico, 64710
Research Site Not yet recruiting
Morelia, Mexico, 58260
Research Site Recruiting
Puebla, Mexico, 72190
Research Site Recruiting
San Juan del Rio, Mexico, 76800
Research Site Completed
Tamaupilas, Mexico, 87070
Research Site Completed
Tampico, Mexico, 89170
Research Site Not yet recruiting
Tlalnepantla, Mexico
Philippines
Research Site Not yet recruiting
Makati, Philippines, 1229
Research Site Not yet recruiting
Manila, Philippines, 1000
Research Site Not yet recruiting
Quezon City, Philippines, 1100
Research Site Not yet recruiting
San Juan, Philippines, 1502
Russian Federation
Research Site Not yet recruiting
Barnaul, Russian Federation, 656024
Research Site Not yet recruiting
Moscow, Russian Federation, 125373
Research Site Not yet recruiting
Samara, Russian Federation, 443079
Research Site Not yet recruiting
Tomsk, Russian Federation, 634050
Research Site Not yet recruiting
Ufa, Russian Federation, 450077
Research Site Not yet recruiting
Yaroslavl, Russian Federation, 150062
South Africa
Research Site Not yet recruiting
Johannesburg, South Africa, 2013
Research Site Not yet recruiting
Moloto, South Africa, 1022
Research Site Recruiting
Paarl, South Africa, 7626
Research Site Not yet recruiting
Pretoria, South Africa, 0087
Research Site Not yet recruiting
Pretoria, South Africa, 0101
Research Site Recruiting
Verulam, South Africa, 4345
Sponsors and Collaborators
AstraZeneca
Quintiles, Inc.
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00658021     History of Changes
Other Study ID Numbers: D5550C00002
First Submitted: April 8, 2008
First Posted: April 14, 2008
Last Update Posted: October 17, 2017
Last Verified: October 2017

Keywords provided by AstraZeneca:
diabetes
adolescents
exenatide
Astra Zeneca

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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists