Safety and Efficacy of Exenatide as Monotherapy

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381342
• Other study ID #: H8O-MC-GWBJ
• Status: Completed
• Phase: Phase 3
• First received: September 25, 2006
• Last updated: February 20, 2015
• Start date: September 2006
• Est. completion date: September 2007

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRomania: National Medicines AgencyRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with type 2 diabetes

• Treating diabetes with diet and exercise

• HbA1c between 6.5% and 10.0%, inclusive

• Body Mass Index (BMI) between 25 kg/m^2 and 45 kg/m^2, inclusive

Exclusion Criteria:

• Have previously completed or withdrawn from this study

• Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry

• Have been treated with any antidiabetic agent

• Have used drugs for weight loss (for example, Xenical, Meridia, Acutrim, or similar over-the counter medications) within 3 months of screening

• Are currently treated with any of the following excluded medications: * drugs that directly affect gastrointestinal motility; * systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• exenatide
Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day
• exenatide
Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day, then exenatide subcutaneous injection, 10 mcg twice a day
• placebo
subcutaneous injection, volume equivalent to appropriate dose of exenatide, twice a day

Locations

Country	Name	City	State
India	Research Site	Aligarh
India	Research Site	Bangalore
India	Research Site	Chennai
India	Research Site	Indore
India	Research Site	Karnal
India	Research Site	New Delhi
India	Research Site	Vellore
Puerto Rico	Research Site	Manati
Puerto Rico	Research Site	San Juan
Romania	Research Site	Alba Iulia
Romania	Research Site	Baia Mare
Romania	Research Site	Bucuresti
Romania	Research Site	Galati
Romania	Research Site	Oradea
Romania	Research Site	Targu Mures
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	St. Petersburg
United States	Research Site	Idaho Falls	Idaho
United States	Research Site	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Countries where clinical trial is conducted

United States,  India,  Puerto Rico,  Romania,  Russian Federation, 

References & Publications (1)

Moretto TJ, Milton DR, Ridge TD, Macconell LA, Okerson T, Wolka AM, Brodows RG. Efficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, para — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 24	Change in HbA1c from Baseline to Week 24	Baseline, Week 24	No
Secondary	Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less	Percentage of subjects achieving HbA1c of 7% or less and of 6.5% or less	Baseline, Weeks 4, 8, 12, 16, 24	No
Secondary	Change in fasting serum glucose (FSG) from Baseline to Week 24	Change in fasting serum glucose (FSG) from Baseline to Week 24 and, if measured, at all visits in between	Baseline, Weeks 4, 8, 12, 16, and 24	No
Secondary	Change in body weight from Baseline to Week 24	Change in body weight (kg) from Baseline to Week 24 and, if measured, at all visits in between	Baseline, Weeks 4, 8, 12, 16, and 24	No
Secondary	Change in glucose measurements from Baseline to Week 24	Change in fasting SMBG profiles (glucose measurements before and 2 hours after meals) from Baseline to Week 24 and, if measured, at all visits in between	Baseline, Weeks 4, 8, 12, 16, 24	No
Secondary	Changes in beta-cell function and insulin sensitivity from Baseline to Week 24	Changes in beta-cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses from Baseline to Week 24 and, if measured, at all visits in between	Baseline, Weeks 4, 8, 12, 16, and 24	No
Secondary	Changes in fasting and 30, 60, 120 and 180-minute glucose measurements	Changes in fasting and 30, 60, 120, 180-minute post glucose load blood concentrations of glucose and insulin	Immediately before glucose load, then 30, 60, 120, and 180 minutes post	No