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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:
ClinicalTrials.gov Identifier:
NCT00240253
First Posted: October 18, 2005
Last Update Posted: March 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
October 14, 2005
October 18, 2005
March 31, 2015
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. [ Time Frame: 16 Weeks ]
To evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes.
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. [ Time Frame: 16 Weeks ]
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.
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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: pramlintide acetate
Clear, colorless, sterile solution for SC injection
Active Comparator: Pramlintide
Intervention: Drug: pramlintide acetate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2006
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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00240253
137-156
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
AstraZeneca
March 2015

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