Status:
COMPLETED
A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00240253
Start Date
October 1 2005
End Date
June 1 2006
Last Update
March 31 2015
Active Locations (34)
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1
Research Site
Phoenix, Arizona, United States
2
Research Site
Concord, California, United States
3
Research Site
La Jolla, California, United States
4
Research Site
Los Gatos, California, United States