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Trial record 2 of 2 for:    Exenatide | Interventional Studies | Philippines

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00658021
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE April 8, 2008
First Posted Date  ICMJE April 14, 2008
Last Update Posted Date April 24, 2020
Actual Study Start Date  ICMJE May 30, 2008
Actual Primary Completion Date April 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2014)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes
Official Title  ICMJE Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes.
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2020)
122
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2008)
195
Actual Study Completion Date  ICMJE April 1, 2020
Actual Primary Completion Date April 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines,   Brazil,   India,   Korea, Republic of,   Mexico,   Russian Federation,   South Africa,   United States
Removed Location Countries China,   Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT00658021
Other Study ID Numbers  ICMJE D5550C00002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment.

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Quintiles, Inc.
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date April 2020

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