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

April 8, 2008
October 22, 2014
May 2008
May 2017   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00658021 on ClinicalTrials.gov Archive Site
  • 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.
Compare exenatide 5-μg BID and exenatide 10-μg BID versus each other and versus placebo with regards to: • the proportion of patients achieving an HbA1c at endpoint of ≤6.5% and ≤7% • body weight • fasting serum glucose • self-monitored blood glucose [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes
Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Placebo
    Subcutaneous injection, twice a day
  • Drug: Exenatide
    Subcutaneous injection, 5 µg, twice a day
  • Drug: Exenatide
    Subcutaneous injection,10 µg, twice a day
  • Placebo Comparator: Placebo
    Subcutaneous injection, twice a day
    Intervention: Drug: Placebo
  • Experimental: Exenatide 5 µg
    Subcutaneous injection, twice a day
    Intervention: Drug: Exenatide
  • Experimental: Exenatide 10 µg
    Subcutaneous injection, twice a day
    Intervention: Drug: Exenatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
195
May 2020
May 2017   (final data collection date for primary outcome measure)

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).
Both
10 Years to 17 Years
No
Contact: Peter Öhman ClinicalTrialTransparency@astrazeneca.com
United States,   Mexico,   India,   Korea, Republic of
 
NCT00658021
D5550C00002
Yes
AstraZeneca
AstraZeneca
inVentiv Health Clinical
Not Provided
AstraZeneca
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP