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Sponsors and Collaborators: |
Amylin Pharmaceuticals, Inc. Eli Lilly and Company |
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Information provided by: | Amylin Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00635492 |
Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimes are being modified in a timely manner and in response to which factors, what treatment changes are made, and clinical outcomes.
Condition | Intervention |
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Type 2 Diabetes Mellitus |
Drug: exenatide Drug: any human insulin or analog insulin |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A European Observational Study of Patients With Type 2 Diabetes Initiating Injectable Therapy to Determine Time to Treatment Change, Factors Associated With Treatment Changes and Outcomes Over 24 Months. |
Estimated Enrollment: | 5600 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1 |
Drug: exenatide
subcutaneous injection, 5mcg or 10mcg, twice a day
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2 |
Drug: any human insulin or analog insulin
subcutaneous injection
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
The study population will consist of patients aged 18 or above, with type 2 diabetes who, together with their physician, have decided to initiate either insulin, or exenatide for the first time for the treatment of type 2 diabetes.
Inclusion Criteria:
Contact: Clinical Trials Support Center | 1-877-CTLILLY (1-877-285-4559) |
Study Director: | James Malone, MD | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company ( James Malone, MD, Study Director ) |
Study ID Numbers: | H8O-EW-B005 |
Study First Received: | February 20, 2008 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00635492 History of Changes |
Health Authority: | France: Ministry of Health; Germany: Ministry of Health; Sweden: Medical Products Agency |
diabetes insulin exenatide |
Byetta Amylin Lilly |
Hypoglycemic Agents Metabolic Diseases Exenatide Amylin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Metabolic Diseases Exenatide Physiological Effects of Drugs Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |