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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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: exenatide/insulin glargine
Drug: insulin glargine/exenatide
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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. [ 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.


Secondary Outcome Measures:
  • 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


Enrollment: 138
Study Start Date: September 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exenatide/insulin glargine
Arm that first receives exenatide, then crosses over to insulin glargine
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
Experimental: Insulin glargine/exenatide
Arm that first receives insulin glargine, then crosses over to exenatide
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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099619

Locations
Australia, New South Wales
Research Site
Westmead, New South Wales, Australia
Australia, South Australia
Research Site
Daw Park, South Australia, Australia
Research Site
Fullarton, South Australia, Australia
Australia, Victoria
Research Site
Box Hill, Victoria, Australia
Research Site
East Ringwood, Victoria, Australia
Greece
Research Site
Athens, Greece
Research Site
Piraeus, Greece
Research Site
Thessaloniki, Greece
Hungary
Research Site
Budapest, Hungary
Research Site
Gyula, Hungary
Research Site
Pecs, Hungary
Research Site
Veszprem, Hungary
Research Site
Zalaegerszeg, Hungary
Italy
Research Site
Bari, Italy
Research Site
Bergamo, Italy
Research Site
Catania, Italy
Research Site
Milan, Italy
Research Site
Perugia, Italy
Research Site
Rome, Italy
Mexico
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Zapopan, Jalisco, Mexico
Research Site
Monterrey, N.l., Mexico
Research Site
Mexico City, Mexico
Poland
Research Site
Bydgoszcz, Poland
Research Site
Gdansk, Poland
Research Site
Lublin, Poland
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: James Malone, MD Eli Lilly and Company
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00099619     History of Changes
Other Study ID Numbers: H8O-MC-GWAO
Study First Received: December 17, 2004
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Mexico: National Institute of Public Health, Health Secretariat
Poland: Ministry of Health

Keywords provided by AstraZeneca:
exenatide
exendin-4
diabetes
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Exenatide
Glargine
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014