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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 4, 2014
Last verified: June 2014

August 1, 2002
June 4, 2014
July 2002
October 2003   (final data collection date for primary outcome measure)
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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
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
Drug: Pramlintide acetate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
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AstraZeneca
AstraZeneca
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Not Provided
AstraZeneca
June 2014

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