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Safety and Efficacy Study of Exenatide Once Weekly 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: NCT01554618
Recruitment Status : Active, not recruiting
First Posted : March 15, 2012
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE March 13, 2012
First Posted Date  ICMJE March 15, 2012
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE December 2, 2011
Estimated Primary Completion Date June 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2015)
  • Assess effect of EQW on glycemic control [ Time Frame: 24 Weeks ]
    measured by HbA1c from Baseline to 24 weeks
  • Safety and tolerability of EQW vs placebo [ Time Frame: 24 weeks ]
    in all patients
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2012)
Change in HbA1c from Baseline [ Time Frame: 14 Weeks ]
14 week placebo-controlled assessment
Change History Complete list of historical versions of study NCT01554618 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2015)
  • Compare effects of EQW vs Placebo [ Time Frame: 24 Weeks ]
    compare effects on: fasting plasma glucose concentration, proportion of patients achieving HbA1c goals, body weight and tanner stage, blood pressure and lipids
  • Assess effects of long term EQW therapy [ Time Frame: 52 weeks ]
    Assess effects on: Long-term safety and tolerability, parameters related to glycemic control, body weight and tanner stage, blood pressure and lipids
  • examine effect of EQW on beta-cell function and insulin sensativity [ Time Frame: 52 weeks ]
    measured by HOMA in children and adolescents not taking insulin
  • Assess pk of EQW [ Time Frame: 52 weeks ]
    in all patients
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2012)
  • Changes in fasting plasma glucose [ Time Frame: 14 Weeks ]
    14 week placebo-controlled assessment
  • Changes in body weight [ Time Frame: 14 weeks ]
    14 week placebo-controlled assessment
  • Changes in lipids [ Time Frame: 14 weeks ]
    14 week placebo-controlled assessment
  • Changes in blood pressure [ Time Frame: 14 weeks ]
    14 week placebo-controlled assessment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes
Official Title  ICMJE A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Assess the Safety and Efficacy of Exenatide Once Weekly in Adolescents With Type 2 Diabetes
Brief Summary The study examines the Safety and efficacy study of exenatide once weekly in children and adolescents with type 2 diabetes
Detailed Description This Phase 3, double-blind (controlled assessment period), randomized, multicenter, placebo-controlled parallel study is designed to examine the efficacy and safety of EQW compared to placebo (PBO) in adolescents with type 2 diabetes for 24 weeks. This study will assess safety and efficacy of EQW (as monotherapy and adjunctive therapy to oral antidiabetic agents and/or insulin). At least 40% and not more than 60% of the randomized patients must be females. At least 40% of patients should be recruited from areas with similar ethnicity and lifestyle to those of the European Union member states. Long term safety and efficacy of EQW will subsequently be monitored for 28 weeks in the open-label, uncontrolled extension period (through Week 52). The study will be terminated at Visit 11 (Week 62/Study Termination) which will be a follow-up visit occurring 10 weeks after the last dose administration at Visit 10 (Week 52). This study will be conducted in 77 patients with type 2 diabetes treated with diet and exercise alone or in combination with a stable dose of oral antidiabetic agents and/or insulin for at least 2 months prior to screening. During the controlled assessment period, approximately 77 patients will be randomly assigned in a 5:2 ratio to either EQW 2 mg (Group A) or PBO (Group B), to yield at least 70 evaluable patients: at least 50 patients in the exenatide and at least 20 patients in the PBO group. Following the 24-week controlled assessment period, patients assigned to the EQW 2 mg treatment (Group A) will continue to be treated with EQW 2 mg during the extension period (through Week 52). Patients randomized to PBO (Group B) will receive EQW 2 mg beginning at the start of the extension period, Week 25 through Week 52. In addition to receiving study medications, all patients will participate in a lifestyle intervention program encompassing diet and physical activity modifications following the signing of the informed consent and assent forms (Visit 1 [Week -2]) through the end of the extension period (Week 52). Following Visit 11 (Week 62/Study Termination), patients whose height increase is at least 5 mm between Visit 8 (Week 28) and Visit 11 (Week 62/Study Termination) will participate in a long-term safety follow-up period. Patients who discontinue study medication prior to Visit 11 (Week 62/Study Termination) will also participate in the Extended Safety Follow-up Period, unless they have a height increase of less than 5 mm over a 6-month interval at study site visits prior to discontinuation of study medication. Patients who do not have height assessments at study-site visits over a 6-month interval prior to discontinuation of study medication will enter the Extended Safety Follow-up Period. The Extended Safety Follow Up Period will continue for up to 3 years or until the difference between two 6-month interval visits is less than a 5 mm increase (whichever comes first). No study medication will be administered during the Extended Safety Follow-up Period. Blood samples will be collected for calcitonin and carcinoembryonic antigen (CEA) laboratory measurements.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Children and Adolescent With Type 2 Diabetes
Intervention  ICMJE
  • Drug: Exenatide Once Weekly
    2 mg exenatide once weekly
    Other Name: BYDUREON
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: EQW
    Exenatide once weekly
    Intervention: Drug: Exenatide Once Weekly
  • Placebo Comparator: Placebo
    Placebo once weekly
    Intervention: Drug: Placebo
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 21, 2019)
84
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2012)
100
Estimated Study Completion Date  ICMJE June 29, 2023
Estimated Primary Completion Date June 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Each patient must meet the following criteria to be enrolled in this study.

  1. Is a child or an adolescent of 10 to <18 years old, at Visit 1 (Screening)
  2. Has been diagnosed with type 2 diabetes mellitus per American Diabetes Association diagnostic criteria
  3. HbA1c of 6.5% to 11.0%, inclusive, in patients not taking insulin/SU, and of 6.5% to 12.0%, inclusive, in patients taking insulin/SU, at Visit 1 (Screening)
  4. Has a C-peptide of >0.6 ng/L at Visit 1 (Screening)
  5. Has been treated with diet and exercise alone or in combination with a stable dose of an oral antidiabetic agent (e.g., metformin and/or SU) and/or insulin for their type 2 diabetes for at least 2 months prior to Visit 1 (Screening)
  6. Has a fasting plasma glucose concentration <280 mg/dL (15.5 mmol/L) at Visit 1 (Screening)

Patients who meet any of the following criteria will be excluded from the study.

  1. Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the Investigator, including but not limited to the following conditions:

    1. Hepatic disease (defined by aspartate or alanine transaminase >3.0 times the upper limit of normal (ULN)
    2. Renal disease or serum creatinine >1.5 mg/dL (132.6 µmol/L) (males) or 1.4 mg/dL (123.8 µmol/L) (females)
    3. Gastrointestinal disease deemed significant by the Investigator
    4. Organ transplantation
    5. Chronic infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus)
    6. Clinically significant malignant disease (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of Visit 1 (Screening)
  2. Has positive antibody titers to glutamic acid decarboxylase (GAD65) or islet cell antigen (ICA512) at Visit 1 (Screening)
  3. Has a personal or family history of elevated calcitonin, calcitonin >100 ng/L, medullary thyroid carcinoma, or multiple endocrine neoplasia-2
  4. Has ever used exenatide (exenatide once weekly [exenatide LAR], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., liraglutide [Victoza®])
  5. Is pregnant
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 Bulgaria,   Hungary,   Israel,   Kuwait,   Mexico,   United States
Removed Location Countries Ukraine
 
Administrative Information
NCT Number  ICMJE NCT01554618
Other Study ID Numbers  ICMJE D5551C00002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date January 2020

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