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
1 other identifier
interventional
200
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes-mellitus
Started Oct 2005
Shorter than P25 for phase_4 type-2-diabetes-mellitus
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 14, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedMarch 31, 2015
March 1, 2015
8 months
October 14, 2005
March 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes.
16 Weeks
Secondary Outcomes (1)
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.
16 Weeks
Study Arms (1)
Pramlintide
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (34)
Research Site
Phoenix, Arizona, United States
Research Site
Concord, California, United States
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La Jolla, California, United States
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Los Gatos, California, United States
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Salinas, California, United States
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Walnut Creek, California, United States
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Denver, Colorado, United States
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New Britain, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Palm Harbor, Florida, United States
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Atlanta, Georgia, United States
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Indianapolis, Indiana, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Bloomfield Hills, Michigan, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Chesterfield, Missouri, United States
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Butte, Montana, United States
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Omaha, Nebraska, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Tipton, Pennsylvania, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Charlottesville, Virginia, United States
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Olympia, Washington, United States
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Spokane, Washington, United States
Related Publications (3)
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.
PMID: 19049375DERIVEDWysham 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.
PMID: 18031595DERIVEDRiddle 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.
PMID: 17698615DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisa Porter, MD
Amylin Pharmaceuticals, LLC.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2005
First Posted
October 18, 2005
Study Start
October 1, 2005
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
March 31, 2015
Record last verified: 2015-03