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OpenTrials
Completed

NCT Number: NCT00042458

Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control

This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ana Ventures LLC, Mesa, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HbA1c value between 7.5-9%
  • Using multiple daily insulin injections

Treatment and study plan

Pramlintide acetate

Drug

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

Placebo

Drug

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

Primary outcomes

  1. - To investigate the safety of pramlintide treatment employing dose titration upon initiation of pramlintide followed by insulin dose optimization in subjects with type 1 diabetes.

    Time frame: 29 Weeks

Secondary outcomes

  1. - To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study.

    Time frame: 29 Weeks

  2. - To examine the pattern of daily insulin use over the course of the study.

    Time frame: 29 Weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety of Pramlintide Treatment Employing Pramlintide Dose-Titration Followed by Insulin Dose Optimization in Subjects With Type 1 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Intensive Insulin Therapy

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
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.

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