Evaluation of the Effect of Pramlintide on Satiety and Food Intake

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00042601
First received: August 1, 2002
Last updated: June 23, 2015
Last verified: June 2015

August 1, 2002
June 23, 2015
July 2002
October 2003   (final data collection date for primary outcome measure)
  • To assess the acute effect of pramlintide on satiety [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
    To assess the acute effect of pramlintide administered subcutaneously (SC) on satiety in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes.
  • Assess the acute effect of pramlintide administered SC on food intake [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]
    To assess the acute effect of pramlintide administered SC on food intake in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes.
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Complete list of historical versions of study NCT00042601 on ClinicalTrials.gov Archive Site
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Evaluation of the Effect of Pramlintide on Satiety and Food Intake
A Single Center, Randomized, Double-blind, Placebo-controlled, Two-period, Crossover Study Evaluating the Acute Effect of Pramlintide on Satiety and Food Intake in Normal-weight and Obese Non-diabetic Subjects and in Insulin Treated Subjects With Type 1 and Type 2 Diabetes Mellitus

This is a single center, randomized, blinded, placebo-controlled, two-period, cross-over study to evaluate the effect of pramlintide on satiety and food intake in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Drug: Pramlintide acetate
Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.
  • Placebo Comparator: Placebo
    A clear, colorless, sterile solution for SC injection manufactured by Amylin Pharmaceuticals, Inc. Placebo solution is the same, sterile preserved formulation, except the active ingredient, pramlintide, is omitted.
  • Active Comparator: Pramlintide
    Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection manufactured by Amylin Pharmaceuticals, Inc. It consists of pramlintide (AC137) 0.6 mg/mL in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative.
    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
51
October 2003
October 2003   (final data collection date for primary outcome measure)

For Healthy Volunteers:

•BMI >=20 to <=25kg/m2 or >=30 to <=40 kg/m2

For Subjects with Type 1 or Type 2 Diabetes:

  • Treated with insulin for at least 6 months prior to screening
  • HbA1c value between 6.5-10% inclusive
  • BMI between 20-40kg/m2
Male
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00042601
137-149
No
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
June 2015

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