Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, Amylin, Symlin, pramlintide, insulin glargine
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.
Interventions
Clear, colorless, sterile solution for SC injection
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed