A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes
- Registration Number
- NCT00240253
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pramlintide pramlintide acetate -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇺🇸Spokane, Washington, United States