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.

First Received: October 14, 2005 Last Updated: October 31, 2006 History of Changes

Sponsored by:	Amylin Pharmaceuticals, Inc.
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00240253

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: pramlintide acetate	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Pramlintide Insulin glargine Pramlintide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:

To evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes.

Secondary Outcome Measures:

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.

Estimated Enrollment:	200
Study Start Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240253

Show 34 Study Locations

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Investigators

Study Director:

Lisa Porter, MD

Amylin Pharmaceuticals, Inc.

More Information

No publications provided by Amylin Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Peyrot M, Rubin RR, Polonsky WH. Diabetes distress and its association with clinical outcomes in patients with type 2 diabetes treated with pramlintide as an adjunct to insulin therapy. Diabetes Technol Ther. 2008 Dec;10(6):461-6.

Wysham C, Lush C, Zhang B, Maier H, Wilhelm K. Effect of pramlintide as an adjunct to basal insulin on markers of cardiovascular risk in patients with type 2 diabetes. Curr Med Res Opin. 2008 Jan;24(1):79-85.

Riddle M, Frias J, Zhang B, Maier H, Brown C, Lutz K, Kolterman O. Pramlintide improved glycemic control and reduced weight in patients with type 2 diabetes using basal insulin. Diabetes Care. 2007 Nov;30(11):2794-9. Epub 2007 Aug 13.

Study ID Numbers:	137-156
Study First Received:	October 14, 2005
Last Updated:	October 31, 2006
ClinicalTrials.gov Identifier:	NCT00240253 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:

diabetes
Amylin
Symlin
pramlintide
insulin glargine

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Amylin
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus

Endocrine System Diseases
Pramlintide
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Glargine

Diabetes Mellitus
Endocrine System Diseases
Pramlintide
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009