Back to resultsComparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
exenatide/insulin glargine
insulin glargine/exenatide
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring exenatide, exendin-4, diabetes, Amylin, Lilly
Eligibility Criteria
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
exenatide/insulin glargine
Insulin glargine/exenatide
Arm Description
Arm that first receives exenatide, then crosses over to insulin glargine
Arm that first receives insulin glargine, then crosses over to exenatide
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00099619
First Posted
December 17, 2004
Last Updated
February 20, 2015
Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00099619
Brief Title
Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
exenatide, exendin-4, diabetes, Amylin, Lilly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exenatide/insulin glargine
Arm Type
Experimental
Arm Description
Arm that first receives exenatide, then crosses over to insulin glargine
Arm Title
Insulin glargine/exenatide
Arm Type
Experimental
Arm Description
Arm that first receives insulin glargine, then crosses over to exenatide
Intervention Type
Drug
Intervention Name(s)
exenatide/insulin glargine
Other Intervention Name(s)
Byetta, AC2003, syntheitc exenden-4
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
insulin glargine/exenatide
Other Intervention Name(s)
Byetta, AC2993, synthetic exenden-4
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Baseline, Week 16, Week 32
Secondary Outcome Measure Information:
Title
Change in patient-reported outcomes from Baseline to the end of each 16-week period
Description
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
Time Frame
Baseline, Week 16, Week 32
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Malone, MD
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Daw Park
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Fullarton
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
East Ringwood
State/Province
Victoria
Country
Australia
Facility Name
Research Site
City
Athens
Country
Greece
Facility Name
Research Site
City
Piraeus
Country
Greece
Facility Name
Research Site
City
Thessaloniki
Country
Greece
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Gyula
Country
Hungary
Facility Name
Research Site
City
Pecs
Country
Hungary
Facility Name
Research Site
City
Veszprem
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg
Country
Hungary
Facility Name
Research Site
City
Bari
Country
Italy
Facility Name
Research Site
City
Bergamo
Country
Italy
Facility Name
Research Site
City
Catania
Country
Italy
Facility Name
Research Site
City
Milan
Country
Italy
Facility Name
Research Site
City
Perugia
Country
Italy
Facility Name
Research Site
City
Rome
Country
Italy
Facility Name
Research Site
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Research Site
City
Zapopan
State/Province
Jalisco
Country
Mexico
Facility Name
Research Site
City
Monterrey
State/Province
N.l.
Country
Mexico
Facility Name
Research Site
City
Mexico City
Country
Mexico
Facility Name
Research Site
City
Bydgoszcz
Country
Poland
Facility Name
Research Site
City
Gdansk
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22236356
Citation
Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
Results Reference
derived
Learn more about this trial
Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy
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