Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This is a randomized, open-label, crossover study to examine the bioavailability of pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus using insulin.
Interventions
Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide is 1.0 mg/mL for SC injection and 0.6 mg/mL for IV bolus injection.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* HbA1c value between 6-12% * BMI \<= 27 kg/m2 or BMI \>=30 to \<= 45 kg/m2 * Consistent insulin regimen for 2 months prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of varying needle length on bioavailability of Pramlintide | approximately 6days but not to exceed 14days | To determine the effect of various anatomical injection sites and varying needle lengths upon the absolute bioavailability of pramlintide when injected subcutaneously (SC) in non-obese and obese subjects with type 1 and type 2 diabetes mellitus using insulin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of varying needle length on safety and tolerability of Pramlintide | Approximately 6 days not to exceed 14days | To assess the safety and tolerability of pramlintide when injected SC at various anatomical sites and with various needle lengths in non-obese and obese subjects with type 1 and type 2 diabetes mellitus using insulin |
Countries
United States
Outcome results
None listed