Evaluation of the Bioavailability of Pramlintide

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00042471

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

18.8

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2	Drug: Pramlintide acetate	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jun 1, 2002

Actual Primary Completion Date :

Dec 1, 2002

Actual Study Completion Date :

Dec 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pramlintide acetate (AC137) injection 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.	Drug: Pramlintide acetate 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. Other Names: Symlin (pramlintide acetate)

Arm

Intervention/Treatment

Experimental: Pramlintide acetate (AC137) injection

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.

Drug: Pramlintide acetate

Other Names:

Symlin (pramlintide acetate)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Orlando Clinical Research Center	Orlando	Florida	United States
2	New Orleans Center for Clinical Research	New Orleans	Louisiana	United States
3	DaVita Clinical Research	Minneapolis	Minnesota	United States
4	CEDRA Clinical Research, LLC	Austin	Texas	United States