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

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ClinicalTrials.gov Identifier: NCT00240253

Recruitment Status : Completed

First Posted : October 18, 2005

Last Update Posted : March 31, 2015

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: pramlintide acetate	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
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
Study Start Date :	October 2005
Actual Primary Completion Date :	June 2006
Actual Study Completion Date :	June 2006

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Type 2 diabetes

Drug Information available for: Pramlintide Pramlintide acetate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Pramlintide	Drug: pramlintide acetate Clear, colorless, sterile solution for SC injection

Outcome Measures

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. [ Time Frame: 16 Weeks ]

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. [ Time Frame: 16 Weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240253

Locations

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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
Research Site
Denver, Colorado, United States
United States, Connecticut
Research Site
New Britain, Connecticut, United States
United States, District of Columbia
Research Site
Washington, District of Columbia, United States
United States, Florida
Research Site
Palm Harbor, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
United States, Indiana
Research Site
Indianapolis, Indiana, United States
United States, Kansas
Research Site
Wichita, Kansas, United States
United States, Kentucky
Research Site
Lexington, Kentucky, United States
United States, Louisiana
Research Site
Baton Rouge, Louisiana, United States
United States, Michigan
Research Site
Bloomfield Hills, Michigan, United States
Research Site
Detroit, Michigan, United States
Research Site
Grand Rapids, Michigan, United States
United States, Missouri
Research Site
Chesterfield, Missouri, United States
United States, Montana
Research Site
Butte, Montana, United States
United States, Nebraska
Research Site
Omaha, Nebraska, United States
United States, North Carolina
Research Site
Charlotte, North Carolina, United States
Research Site
Durham, North Carolina, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Oregon
Research Site
Medford, Oregon, United States
Research Site
Portland, Oregon, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Tipton, Pennsylvania, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
United States, Texas
Research Site
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

AstraZeneca

Investigators

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Study Director:	Lisa Porter, MD	Amylin Pharmaceuticals, LLC.

More Information

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. doi: 10.1089/dia.2008.0031.

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.

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Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00240253
Other Study ID Numbers:	137-156
First Posted:	October 18, 2005 Key Record Dates
Last Update Posted:	March 31, 2015
Last Verified:	March 2015

Keywords provided by AstraZeneca:


diabetes Amylin Symlin pramlintide insulin glargine

Additional relevant MeSH terms:

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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases	Endocrine System Diseases Pramlintide Hypoglycemic Agents Physiological Effects of Drugs

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