A Phase 2 interventional study of Pramlintide acetate and Placebo in Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by AstraZeneca. Completed at 1 site in Australia. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-10-21.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 51 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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For Healthy Volunteers:
•BMI >=20 to \<=25kg/m2 or >=30 to \<=40 kg/m2
For Subjects with Type 1 or Type 2 Diabetes:
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.
Drug: Placebo
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.
placebo injection will be supplied in 5-mL multidose glass vials with a rubber stopper
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).
Time frame: 2 Weeks
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).
Time frame: 2 Weeks
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.
Time frame: 2 Weeks
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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