Back to resultsEvaluation of the Effect of Pramlintide on Satiety and Food Intake
Primary Purpose
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Pramlintide acetate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
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
Sites / Locations
- Royal Adelaide Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Pramlintide
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in satiety of participants on Pramlintide
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
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 Outcome Measures
Effect of pramlintide on postprandial metabolic and hormonal responses
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00042601
Brief Title
Evaluation of the Effect of Pramlintide on Satiety and Food Intake
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Pramlintide
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Pramlintide acetate
Intervention Description
Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo injection will be supplied in 5-mL multidose glass vials with a rubber stopper
Primary Outcome Measure Information:
Title
Change in satiety of participants on Pramlintide
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).
Time Frame
2 Weeks
Title
Change in food intake of participants on Pramlintide
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).
Time Frame
2 Weeks
Secondary Outcome Measure Information:
Title
Effect of pramlintide on postprandial metabolic and hormonal responses
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.
Time Frame
2 Weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
12. IPD Sharing Statement
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Evaluation of the Effect of Pramlintide on Satiety and Food Intake
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