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

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ClinicalTrials.gov Identifier: NCT00042458
Recruitment Status : Completed
First Posted : August 1, 2002
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Pramlintide acetate Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2002
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.Ingredients: D-Mannitol 43.0 mg/mL Metacresol 2.25 mg/mL Glacial acetic acid 1.53 mg/mL Sodium acetate trihydrate 0.61 mg/mL pH 4.0 Water for injection qs to 5.0 mL
Drug: Placebo
The placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.
Active Comparator: Pramlintide Acetate (AC137)
Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide 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. The strength of pramlintide injection is 0.6 mg/mL
Drug: Pramlintide acetate
Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042458


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Sponsors and Collaborators
AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00042458     History of Changes
Other Study ID Numbers: 137-150
First Posted: August 1, 2002    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pramlintide
Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Amylin Receptor Agonists
Molecular Mechanisms of Pharmacological Action