A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00240253
First received: October 14, 2005
Last updated: September 18, 2013
Last verified: September 2013

October 14, 2005
September 18, 2013
October 2005
June 2006   (final data collection date for primary outcome measure)
To evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes.
Same as current
Complete list of historical versions of study NCT00240253 on ClinicalTrials.gov Archive Site
To evaluate the effects of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes on markers of cardiovascular risk, fasting serum lipids, fasting plasma glucose, waist circumference, and patient-reported outcomes.
Same as current
Not Provided
Not Provided
 
A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes Who Are Not Achieving Glycemic Targets

The purpose of this study is to evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes who are not achieving glycemic targets.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: pramlintide acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
Not Provided
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has HbA1c >7.0% and <=10.5%
  • Has a body mass index (BMI) >=25 kg/m2 and <=45 kg/m2
  • Has received insulin glargine for 3 months prior to study start and has been on a stable dose for 1 month prior to study start
  • If taking oral antidiabetic agents, has been on a stable dose for at least 2 months

Exclusion Criteria:

  • Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study)
  • Has received any investigational drug within 1 month of screening
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00240253
137-156
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
Bristol-Myers Squibb
September 2013

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