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Evaluation of the Bioavailability of Pramlintide

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00042471
First Posted: August 1, 2002
Last Update Posted: September 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
July 30, 2002
August 1, 2002
September 23, 2015
June 2002
December 2002   (Final data collection date for primary outcome measure)
Effect of varying needle length on bioavailability of Pramlintide [ Time Frame: 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.
Not Provided
Complete list of historical versions of study NCT00042471 on ClinicalTrials.gov Archive Site
Effect of varying needle length on safety and tolerability of Pramlintide [ Time Frame: 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
Not Provided
Not Provided
Not Provided
 
Evaluation of the Bioavailability of Pramlintide
Not Provided
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
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 Name: Symlin (pramlintide acetate)
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.
Intervention: Drug: Pramlintide acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
December 2002
December 2002   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00042471
137-153
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP