Trial · Interventional
CompletedPhase 2Registry dataEvaluation of the Effect of Pramlintide on Satiety and Food Intake
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 51 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Randomized · Triple masking
- Countries
1 country
Australia
- Start
- Jul 2002
- Primary completion
- Oct 2003
- Completion
- Oct 2003
- First posted
- 5 Aug 2002 (estimated)
- Last update posted
- 21 Oct 2015 (estimated)
- Conditions
- Diabetes Mellitus, Type 1 · Diabetes Mellitus, Type 2
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Pramlintide acetateDrug
- PlaceboDrug
Arms2
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.
Primary outcomes2
Outcomes the sponsor listed as primary.
Change in satiety of participants on Pramlintide
Time frame · 2 Weeks
Registry description
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. To be measured by Total caloric intake, macronutrient intake (carbohydrate, fat, protein, and other), duration of buffet meal, aand satiety data measured via a satiety assessment at Period 1 (Visit 2) and Period 2 (Visit 3).
Change in food intake of participants on Pramlintide
Time frame · 2 Weeks
Registry description
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. To be measured by Total caloric intake, macronutrient intake (carbohydrate, fat, protein, and other), duration of buffet meal, aand satiety data measured via a satiety assessment at Period 1 (Visit 2) and Period 2 (Visit 3).
Secondary outcomes(1)
Effect of pramlintide on postprandial metabolic and hormonal responses
Time frame · 2 Weeks
Registry description
To assess the acute effect of pramlintide administered SC on postprandial metabolic and hormonal responses \[glucose, triglycerides, total cholesterol, insulin, cholecystokinin (CCK), and glucagon-like peptide (GLP-1)\] in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes. To be measured by the calculation of both absolute and incremental plasma analyte concentration profiles.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years up to 70 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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