A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes
March 26, 2015 updated by: AstraZeneca
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States
- Research Site
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California
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Concord, California, United States
- Research Site
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La Jolla, California, United States
- Research Site
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Los Gatos, California, United States
- Research Site
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Salinas, California, United States
- Research Site
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Walnut Creek, California, United States
- Research Site
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Colorado
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Denver, Colorado, United States
- Research Site
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Connecticut
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New Britain, Connecticut, United States
- Research Site
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District of Columbia
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Washington, District of Columbia, United States
- Research Site
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Florida
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Palm Harbor, Florida, United States
- Research Site
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Georgia
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Atlanta, Georgia, United States
- Research Site
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Indiana
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Indianapolis, Indiana, United States
- Research Site
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Kansas
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Wichita, Kansas, United States
- Research Site
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Kentucky
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Lexington, Kentucky, United States
- Research Site
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Louisiana
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Baton Rouge, Louisiana, United States
- Research Site
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Michigan
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Bloomfield Hills, Michigan, United States
- Research Site
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Detroit, Michigan, United States
- Research Site
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Grand Rapids, Michigan, United States
- Research Site
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Missouri
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Chesterfield, Missouri, United States
- Research Site
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Montana
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Butte, Montana, United States
- Research Site
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Nebraska
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Omaha, Nebraska, United States
- Research Site
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North Carolina
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Charlotte, North Carolina, United States
- Research Site
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Durham, North Carolina, United States
- Research Site
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Ohio
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Cincinnati, Ohio, United States
- Research Site
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Oklahoma
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Oklahoma City, Oklahoma, United States
- Research Site
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Oregon
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Medford, Oregon, United States
- Research Site
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Portland, Oregon, United States
- Research Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States
- Research Site
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Tipton, Pennsylvania, United States
- Research Site
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Tennessee
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Nashville, Tennessee, United States
- Research Site
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Texas
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Dallas, Texas, United States
- Research Site
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Virginia
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Charlottesville, Virginia, United States
- Research Site
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Washington
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Olympia, Washington, United States
- Research Site
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Spokane, Washington, United States
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Pramlintide
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Clear, colorless, sterile solution for SC injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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16 Weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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16 Weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1185/030079908x253537.
- 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. doi: 10.2337/dc07-0589. Epub 2007 Aug 13.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
October 14, 2005
First Submitted That Met QC Criteria
October 14, 2005
First Posted (Estimate)
October 18, 2005
Study Record Updates
Last Update Posted (Estimate)
March 31, 2015
Last Update Submitted That Met QC Criteria
March 26, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 137-156
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.