DRUG
pramlintide acetate
Clear, colorless, sterile solution for SC injection
A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes
Status
Completed
Phase
Phase 4
Enrollment
200
Locations
34
Results
Not posted
Publications
3
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Oct 18, 2005
Study start
Oct 2005
Primary completion
Jun 2006
Study completion
Jun 2006
Results posted
Not reported
Registry updated
Mar 31, 2015
Outcomes
What the study measures.
Primary outcomes
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 outcomes
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
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
34 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Research Site
Phoenix, Arizona, United States
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
Research Site
Denver, Colorado, United States
Research Site
New Britain, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Palm Harbor, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Wichita, Kansas, United States
Research Site
Lexington, Kentucky, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Bloomfield Hills, Michigan, United States
Research Site
Detroit, Michigan, United States
Research Site
Grand Rapids, Michigan, United States
Research Site
Chesterfield, Missouri, United States
Research Site
Butte, Montana, United States
Research Site
Omaha, Nebraska, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Durham, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Publications
Results and literature.
PMID 19049375 ↗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 18031595 ↗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.PMID 17698615 ↗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.
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