Evaluation of the Effect of Pramlintide on Satiety and Food Intake

NCT00042601 | Completed Phase 2

• 1 other identifier: 137-149
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  2 Weeks

Secondary Outcomes (1)

• Effect of pramlintide on postprandial metabolic and hormonal responses

  2 Weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

ACTIVE COMPARATOR

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

Interventions

Pramlintide acetate DRUG

Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.

Pramlintide

Placebo DRUG

placebo injection will be supplied in 5-mL multidose glass vials with a rubber stopper

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

pramlintide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2002
• First Posted: August 5, 2002
• Study Start: July 1, 2002
• Primary Completion: October 1, 2003
• Study Completion: October 1, 2003
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

AU (1)