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

NCT00658021 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2020-12-01

Study results available
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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

Conditions

Interventions

DRUG

Placebo

Subcutaneous injection, twice a day

DRUG

Exenatide

Subcutaneous injection, 5 µg, twice a day

DRUG

Exenatide

Subcutaneous injection,10 µg, twice a day

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-30
Primary Completion
2019-04-18
Completion
2020-04-01

Countries

  • United States
  • Brazil
  • India
  • Mexico
  • Philippines
  • Russia
  • South Africa
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00658021 on ClinicalTrials.gov