Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Efficacy of Exenatide Compared With Insulin Glargine in Patients With Type 2 Diabetes Using Metformin or Sulfonylurea for Whom Insulin is the Next Appropriate Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099619
• Other study ID #: H8O-MC-GWAO
• Status: Completed
• Phase: Phase 3
• First received: December 17, 2004
• Last updated: February 20, 2015
• Start date: September 2004
• Est. completion date: August 2005

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationGreece: National Organization of MedicinesHungary: National Institute of PharmacyItaly: Ministry of HealthMexico: National Institute of Public Health, Health SecretariatPoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Main Inclusion Criteria:

• Treated with a stable dose of metformin or sulfonylurea for at least 3 months prior to screening.

• HbA1c between 7.1% and 11.0%, inclusive.

• Insulin therapy should be the next appropriate step of diabetes treatment.

• Body Mass Index (BMI) >25 kg/m2 and <40 kg/m2.

Main Exclusion Criteria:

• Patient previously in a study involving exenatide or glucagon-like peptide-1 analogs.

• Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 months prior to screening.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• exenatide/insulin glargine
Subcutaneously injected exenaide 10 mcg twice daily for 16 weeks; then insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels
• insulin glargine/exenatide
Subcutaneously injected insulin glargine subcutaneously injected once daily for 16 weeks given in a dose that varies for individuals to achieve target glucose levels; then exenaide 10 mcg twice daily for 16 weeks

Locations

Country	Name	City	State
Australia	Research Site	Box Hill	Victoria
Australia	Research Site	Daw Park	South Australia
Australia	Research Site	East Ringwood	Victoria
Australia	Research Site	Fullarton	South Australia
Australia	Research Site	Westmead	New South Wales
Greece	Research Site	Athens
Greece	Research Site	Piraeus
Greece	Research Site	Thessaloniki
Hungary	Research Site	Budapest
Hungary	Research Site	Gyula
Hungary	Research Site	Pecs
Hungary	Research Site	Veszprem
Hungary	Research Site	Zalaegerszeg
Italy	Research Site	Bari
Italy	Research Site	Bergamo
Italy	Research Site	Catania
Italy	Research Site	Milan
Italy	Research Site	Perugia
Italy	Research Site	Rome
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Mexico City
Mexico	Research Site	Monterrey	N.l.
Mexico	Research Site	Zapopan	Jalisco
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdansk
Poland	Research Site	Lublin

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Countries where clinical trial is conducted

Australia,  Greece,  Hungary,  Italy,  Mexico,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (glycosylated hemoglobin) from the baseline of the first period (16-weeks of exenatide or insulin) to the end of each 16-week period.	Change in HbA1c from Baseline to the end of each 16-week period. There is one 16-week period of exenatide treatment and one 16-week period of insulin glargine.	Baseline, Week 16, Week 32	No
Secondary	Change in patient-reported outcomes from Baseline to the end of each 16-week period	Change in patient-based outcomes (Hypoglycemic Fear Survey, patient-preference questionnaires [Treatment Evaluation and Treatment Preference questionnaires), Diabetes Symptom Checklist-Revised, Diabetes Treatment Flexibility Scale, Psychological General Well-Being Index, and the EuroQol (EQ-5D) instrument] from Baseline to the end of each 16-week exenatide or insulin glargine period	Baseline, Week 16, Week 32	No