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

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 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin human Pramlintide Insulin glargine Pramlintide acetate

U.S. FDA Resources

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

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
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

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

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Locations

United States, Arizona
Research Site
Phoenix, Arizona, United States
United States, California
Research Site
Concord, California, United States
Research Site
La Jolla, California, United States
Research Site
Los Gatos, California, United States
Research Site
Salinas, California, United States
Research Site
Walnut Creek, California, United States
United States, Colorado
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Denver, Colorado, United States
United States, Connecticut
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New Britain, Connecticut, United States
United States, District of Columbia
Research Site
Washington, District of Columbia, United States
United States, Florida
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Palm Harbor, Florida, United States
United States, Georgia
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Atlanta, Georgia, United States
United States, Indiana
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Indianapolis, Indiana, United States
United States, Kansas
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Wichita, Kansas, United States
United States, Kentucky
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Lexington, Kentucky, United States
United States, Louisiana
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Baton Rouge, Louisiana, United States
United States, Michigan
Research Site
Bloomfield Hills, Michigan, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
United States, Missouri
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Chesterfield, Missouri, United States
United States, Montana
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Butte, Montana, United States
United States, Nebraska
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Omaha, Nebraska, United States
United States, North Carolina
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
United States, Ohio
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Cincinnati, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Oregon
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Medford, Oregon, United States
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Portland, Oregon, United States
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States
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Tipton, Pennsylvania, United States
United States, Tennessee
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Nashville, Tennessee, United States
United States, Texas
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Dallas, Texas, United States
United States, Virginia
Research Site
Charlottesville, Virginia, United States
United States, Washington
Research Site
Olympia, Washington, United States
Research Site
Spokane, Washington, United States

Sponsors and Collaborators

Amylin Pharmaceuticals, LLC.

Investigators

Study Director:

Lisa Porter, MD

Amylin Pharmaceuticals, LLC.

More Information

No publications provided by Amylin Pharmaceuticals, LLC.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00240253 History of Changes
Other Study ID Numbers:	137-156
Study First Received:	October 14, 2005
Last Updated:	February 11, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, LLC.:

diabetes
Amylin
Symlin
pramlintide
insulin glargine

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pramlintide
Glargine
Insulin
Insulin, Long-Acting

Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013