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Sponsored by: |
Amylin Pharmaceuticals, Inc. |
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Information provided by: | Amylin Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00467649 |
This will be a randomized, open label, parallel group, multicenter study. There will be two phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients with type 2 diabetes who have either been on a prior regimen of insulin for less than 6 months and were taking less than 50 U total of insulin per day OR are candidates for the initiation of insulin therapy. The purpose of Phase 2 (Week 24 to Week 36) is to explore further intensification of diabetes regimens in patients failing to achieve HbA1c <=6.5% at Week 24.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: pramlintide acetate Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]) Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir]) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 4, Randomized, Open Label, Parallel Group, Multicenter Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes |
Estimated Enrollment: | 110 |
Study Start Date: | April 2007 |
Study Completion Date: | May 2008 |
Arms | Assigned Interventions |
---|---|
Group A: Experimental |
Drug: pramlintide acetate
subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
subcutaneous injection, dosing based on titration guidelines
|
Group B: Active Comparator |
Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])
subcutaneous injection, dosing based on titration guidelines
Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
subcutaneous injection, dosing based on titration guidelines
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Lisa Porter, MD | Amylin Pharmaceuticals, Inc. |
Responsible Party: | Amylin Pharmaceuticals ( Lisa Porter, MD, Study Director ) |
Study ID Numbers: | ACA401 |
Study First Received: | April 27, 2007 |
Last Updated: | May 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00467649 |
Health Authority: | United States: Institutional Review Board |
Symlin Amylin insulin |
Humalog Novolog Apidra |
Metabolic Diseases Insulin glulisine Diabetes Mellitus Endocrine System Diseases Insulin LISPRO Insulin Diabetes Mellitus, Type 2 |
Glargine Insulin, Asp(B28)- Pramlintide Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |