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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01554618 |
Recruitment Status
:
Recruiting
First Posted
: March 15, 2012
Last Update Posted
: April 19, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Children and Adolescent With Type 2 Diabetes | Drug: Exenatide Once Weekly Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 77 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 : | May 12, 2016 |
Estimated Primary Completion Date : | June 22, 2020 |
Estimated Study Completion Date : | June 29, 2023 |

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
Placebo
|
- 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
- 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

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.
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.
- Is a child or an adolescent of 10 to <18 years old, at Visit 1 (Screening)
- Has been diagnosed with type 2 diabetes mellitus per American Diabetes Association diagnostic criteria
- 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)
- Has a C-peptide of >0.6 ng/L at Visit 1 (Screening)
- 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)
- 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.
-
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:
- Hepatic disease (defined by aspartate or alanine transaminase >3.0 times the upper limit of normal (ULN)
- Renal disease or serum creatinine >1.5 mg/dL (132.6 µmol/L) (males) or 1.4 mg/dL (123.8 µmol/L) (females)
- Gastrointestinal disease deemed significant by the Investigator
- Organ transplantation
- Chronic infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus)
- Clinically significant malignant disease (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of Visit 1 (Screening)
- Has positive antibody titers to glutamic acid decarboxylase (GAD65) or islet cell antigen (ICA512) at Visit 1 (Screening)
- Has a personal or family history of elevated calcitonin, calcitonin >100 ng/L, medullary thyroid carcinoma, or multiple endocrine neoplasia-2
- 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®])
- Is pregnant

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 ClinicalTrials.gov identifier (NCT number): NCT01554618
Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |

Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01554618 History of Changes |
Other Study ID Numbers: |
D5551C00002 |
First Posted: | March 15, 2012 Key Record Dates |
Last Update Posted: | April 19, 2018 |
Last Verified: | April 2018 |
Keywords provided by AstraZeneca:
exenatide type 2 diabetes GLP-1 receptor agonist |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide |
Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |