Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes

This study has suspended participant recruitment.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: March 13, 2012
Last updated: September 17, 2015
Last verified: July 2015
The study examines the Safety and efficacy study of exenatide once weekly in children and adolescents with type 2 diabetes.

Condition Intervention Phase
Children and Adolescent With Type 2 Diabetes
Drug: Exenatide Once Weekly
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Assess effect of EQW on glycemic control [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    measured by HbA1c from Baseline to 24 weeks

  • Safety and tolerability of EQW vs placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    in all patients

Secondary Outcome Measures:
  • Compare effects of EQW vs Placebo [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    measured by HOMA in children and adolescents not taking insulin

  • Assess pk of EQW [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    in all patients

Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EQW
Exenatide once weekly
Drug: Exenatide Once Weekly
2 mg exenatide once weekly
Other Name: BYDUREON
Placebo Comparator: Placebo
Placebo once weekly
Drug: Placebo

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.

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

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
  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 identifier: NCT01554618

Research Site
Guadalajara, Jalisco, Mexico
Research Site
Morelia, Michoacan, Mexico
Research Site
Culiacan, Sinaloa, Mexico
Reserach Site
Mexico City, Mexico
Research Site
Chernivtsi, Ukraine
Research Site
Donetsk, Ukraine
Research Site
Kiev, Ukraine
Research Site
Poltava, Ukraine
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: AstraZeneca Identifier: NCT01554618     History of Changes
Other Study ID Numbers: D5551C00002
Study First Received: March 13, 2012
Last Updated: September 17, 2015
Health Authority: United States: Food and Drug Administration
Ukraine: Ministry of Health
Mexico: Ministry of Health

Keywords provided by AstraZeneca:
type 2 diabetes
GLP-1 receptor agonist

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 27, 2015