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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: pramlintide acetate
  • subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Group A
• Active Comparator: Group B

Primary Measures

• To compare the efficacy and safety of regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients with type 2 diabetes.
  • Time Frame: 24 weeks
    Safety Issue?: No

Secondary Measures

• To explore the effects of intensifying basal insulin regimens with either Symlin or rapid acting insulin in patients with type 2 diabetes.
  • Time Frame: 24 weeks
    Safety Issue?: No
• To explore the effects of further intensification of diabetes regimens in patients failing to achieve HbA1c ≤6.5% at Week 24.
  • Time Frame: 36 weeks
    Safety Issue?: No

Inclusion Criteria:

• Has a clinical diagnosis of type 2 diabetes mellitus
• Has an HbA1c >7.0% and ≤10.0%
• Has a BMI of ≥25 kg/m^2 and ≤50 kg/m^2
• Has been on a regimen of insulin for less than 6 months and is taking less than 50 U total of insulin per day, OR has not been on a pre existing insulin regimen and is a candidate for the initiation of basal insulin therapy

Exclusion Criteria:

• Has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months
• Requires the use of drugs that stimulate gastrointestinal motility
• Has been previously treated with Symlin (or has participated in a Symlin clinical study)
• Is currently being treated with any of the following medications: *Over-the-counter antiobesity agents (including, but not limited to, herbal supplements) or prescription antiobesity agents (including orlistat [Xenical®] and sibutramine [Meridia®]); *Oral, intravenous, or intramuscular systemic steroids by oral or potent inhaled or intrapulmonary steroids that are known to have a high rate of systemic absorption;
• *Drugs that directly affect gastrointestinal motility, including but not limited to: dopamine antagonists (e.g., metoclopramide [Reglan®]), opiates or anticholinergics;
• and chronic (more than 10 days within a 6-month period) macrolide antibiotics such as erythromycin and newer derivatives; *Investigational medications
• Has a history or presence of any of the following: *Eating disorders (including anorexia and/or bulimia); *Bariatric surgery (gastric bypass, gastric banding, or gastroplasty)
• Is currently enrolled in a weight-loss program or plans to enroll in a weight-loss program before termination of the study
• Has donated blood within 30 days of study start or plans to donate blood during the duration of the study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Amylin Pharmaceuticals, Inc.

Overall Clinical Trial Officials and Contacts

Lisa Porter, MD Study Director Amylin Pharmaceuticals, Inc.  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00467649

Study ID Number: ACA401

ClinicalTrials.gov Identifier: NCT00467649

Health Authority: United States: Institutional Review Board