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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00099619
First received: December 17, 2004
Last updated: June 6, 2014
Last verified: June 2014

December 17, 2004
June 6, 2014
September 2004
August 2005   (final data collection date for primary outcome measure)
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. [ Time Frame: Baseline, Week 16, Week 32 ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00099619 on ClinicalTrials.gov Archive Site
Change in patient-reported outcomes from Baseline to the end of each 16-week period [ Time Frame: Baseline, Week 16, Week 32 ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
Not Provided
 
Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
    Other Names:
    • Byetta
    • AC2003
    • syntheitc exenden-4
  • Drug: 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
    Other Names:
    • Byetta
    • AC2993
    • synthetic exenden-4
  • Experimental: exenatide/insulin glargine
    Arm that first receives exenatide, then crosses over to insulin glargine
    Intervention: Drug: exenatide/insulin glargine
  • Experimental: Insulin glargine/exenatide
    Arm that first receives insulin glargine, then crosses over to exenatide
    Intervention: Drug: insulin glargine/exenatide
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
August 2005
August 2005   (final data collection date for primary outcome measure)

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.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Greece,   Hungary,   Italy,   Mexico,   Poland
 
NCT00099619
H8O-MC-GWAO
No
AstraZeneca
AstraZeneca
Eli Lilly and Company
Study Director: James Malone, MD Eli Lilly and Company
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP