Evaluation of the Bioavailability of Pramlintide

This is a randomized, open-label, crossover study to examine the bioavailability of pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus using insulin.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Orlando Clinical Research Center, Orlando, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

HbA1c value between 6-12%
BMI <= 27 kg/m2 or BMI >=30 to <= 45 kg/m2
Consistent insulin regimen for 2 months prior to screening

Treatment and study plan

Pramlintide acetate

Drug

Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide is 1.0 mg/mL for SC injection and 0.6 mg/mL for IV bolus injection.

Other names: Symlin (pramlintide acetate)

Primary outcomes

Effect of varying needle length on bioavailability of Pramlintide

Time frame: approximately 6days but not to exceed 14days

To determine the effect of various anatomical injection sites and varying needle lengths upon the absolute bioavailability of pramlintide when injected subcutaneously (SC) in non-obese and obese subjects with type 1 and type 2 diabetes mellitus using insulin.

Secondary outcomes

Effect of varying needle length on safety and tolerability of Pramlintide

Time frame: Approximately 6 days not to exceed 14days

To assess the safety and tolerability of pramlintide when injected SC at various anatomical sites and with various needle lengths in non-obese and obese subjects with type 1 and type 2 diabetes mellitus using insulin

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start: 2002
Primary completion: 2002
Study completion: 2002
First posted: Aug 1, 2002
Registry last updated: Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed