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

• ClinicalTrials.gov Identifier: NCT00658021
• Recruitment Status: Suspended
• First Posted: April 14, 2008
• Last Update Posted: August 22, 2019
• Sponsor: AstraZeneca
• Collaborator: Quintiles, Inc.
• Information provided by (Responsible Party): AstraZeneca

Study Description

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

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes	Drug: Placebo; Drug: Exenatide	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 195 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes.
• Actual Study Start Date: May 30, 2008
• Estimated Primary Completion Date: March 10, 2020
• Estimated Study Completion Date: March 6, 2023

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Subcutaneous injection, twice a day	Drug: Placebo; Subcutaneous injection, twice a day
Experimental: Exenatide 5 µg; Subcutaneous injection, twice a day	Drug: Exenatide; Subcutaneous injection, 5 µg, twice a day
Experimental: Exenatide 10 µg; Subcutaneous injection, twice a day	Drug: Exenatide; Subcutaneous injection,10 µg, twice a day

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. The primary endpoint is change in A1c from baseline compared to placebo. [ Time Frame: 28 weeks ]

Secondary Outcome Measures :

1. 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 ]
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

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Sponsors and Collaborators

AstraZeneca

Quintiles, Inc.

More Information

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00658021 History of Changes
• Other Study ID Numbers: D5550C00002
• First Posted: April 14, 2008
• Last Update Posted: August 22, 2019
• Last Verified: August 2019

Keywords provided by AstraZeneca:

diabetes; adolescents; exenatide; Astra Zeneca

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; Anti-Obesity Agents; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists