Evaluation of the Bioavailability of Pramlintide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00042471
First received: July 30, 2002
Last updated: September 22, 2015
Last verified: August 2015

July 30, 2002
September 22, 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 ] [ Designated as safety issue: Yes ]
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
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Evaluation of the Bioavailability of Pramlintide
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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.
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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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
Both
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00042471
137-153
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AstraZeneca
AstraZeneca
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Not Provided
AstraZeneca
August 2015

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