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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. Identifier: NCT01554618
Recruitment Status : Active, not recruiting
First Posted : March 15, 2012
Last Update Posted : January 13, 2020
Information provided by (Responsible Party):

Brief Summary:
The study examines the Safety and efficacy study of exenatide once weekly in children and adolescents with type 2 diabetes

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : December 2, 2011
Estimated Primary Completion Date : June 22, 2020
Estimated Study Completion Date : June 29, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Assess effect of EQW on glycemic control [ Time Frame: 24 Weeks ]
    measured by HbA1c from Baseline to 24 weeks

  2. Safety and tolerability of EQW vs placebo [ Time Frame: 24 weeks ]
    in all patients

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Assess pk of EQW [ Time Frame: 52 weeks ]
    in all patients

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.

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT01554618

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United States, California
Research Site
Los Angeles, California, United States, 90027
United States, Connecticut
Research Site
New Haven, Connecticut, United States, 06511
United States, Iowa
Research Site
Iowa City, Iowa, United States, 52242
United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02115
United States, Mississippi
Research Site
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Research Site
Kansas City, Missouri, United States, 64111
United States, New York
Research Site
Buffalo, New York, United States, 14222
United States, North Carolina
Research Site
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Research Site
Cleveland, Ohio, United States, 44106-6010
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73104
United States, South Dakota
Research Site
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37232
United States, Texas
Research Site
Dallas, Texas, United States, 75390
Research Site
Houston, Texas, United States, 77030
Research Site
Pleven, Bulgaria, 5800
Research Site
Sevlievo, Bulgaria, 5400
Research Site
Baja, Hungary, 6500
Research Site
Budapest, Hungary, 1023
Research Site
Budapest, Hungary, 1083
Research Site
Budapest, Hungary, 1094
Research Site
Beer Sheva, Israel, 84101
Research Site
Haifa, Israel, 31096
Research Site
Ramat Gan, Israel, 5265601
Research Site
Kuwait City, Kuwait, 1180
Research Site
Aguascalientes, Mexico, 20016
Research Site
Durango, Mexico, 34000
Research Site
Guadalajara, Mexico, 44130
Research Site
Veracruz, Mexico, 91910
Sponsors and Collaborators

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Responsible Party: AstraZeneca Identifier: NCT01554618    
Other Study ID Numbers: D5551C00002
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Keywords provided by AstraZeneca:
type 2 diabetes
GLP-1 receptor agonist
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Hormones, Hormone Substitutes, and Hormone Antagonists