Evaluation of the Effect of Pramlintide on Satiety and Food Intake
Study identifier:137-149
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Diabetes Mellitus, Type 1
Phase
Phase 2
Healthy volunteers
No
Study drug
Pramlintide acetate
Sex
Male
Actual Enrollment
51
Study type
Interventional
Age
18 Years - 70 Years
Date
Study Start Date: 01 Jul 2002
Primary Completion Date: 01 Oct 2003
Study Completion Date: 01 Oct 2003
Study design
Allocation: Randomized
Endpoint Classification: Efficacy
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| 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. | Drug: Pramlintide acetate Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers. |
