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A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
This study has been completed.
Study NCT00467649   Information provided by Amylin Pharmaceuticals, Inc.
First Received: April 27, 2007   Last Updated: April 10, 2009   History of Changes

April 27, 2007
April 10, 2009
April 2007
 
The Proportion of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00467649 on ClinicalTrials.gov Archive Site
  • Proportion of Patients Achieving HbA1c <=7% at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Proportion of Patients With no Weight Gain at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Proportion of Patients With a Severe Hypoglycemia Adverse Event [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change in HbA1c From Baseline at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change in Body Weight From Baseline at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change in Waist Circumference From Baseline [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change in Fasting Plasma Glucose From Baseline [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Fasting Serum Lipids Change From Baseline at Week 24 [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Phase 2: Change in HbA1c at Week 36 [ Time Frame: 36 Weeks ] [ Designated as safety issue: No ]
  • Phase 2: Change in Body Weight at Week 36 [ Time Frame: 36 Weeks ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 ]
 
A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
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.

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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])
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
113
May 2008
 

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00467649
Lisa Porter, MD, Study Director, Amylin Pharmaceuticals
ACA401
Amylin Pharmaceuticals, Inc.
 
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, Inc.
Amylin Pharmaceuticals, Inc.
April 2009

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