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Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00107107
Recruitment Status : Completed
First Posted : April 6, 2005
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a multicenter, open-label extension study designed to examine the long-term safety of pramlintide treatment in subjects with type 1 diabetes who have successfully completed treatment in the parent study 137-150.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Extension Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus Completing Protocol 137-150
Study Start Date : November 2002
Primary Completion Date : June 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Pramlintide Acetate
Pramlintide acetate 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 concentration of pramlintide injection to be used in this study is 0.6 mg/mL.
Drug: pramlintide acetate
Syringe vial and Pen-cartridge


Outcome Measures

Primary Outcome Measures :
  1. To investigate the long term safety profile of pramlintide treatment in subjects with type 1 diabetes completing protocol 137-150. [ Time Frame: participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available ]
  2. To examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight [ Time Frame: participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available ]

Secondary Outcome Measures :
  1. To examine the effects of long term pramlintide treatment on HbA1c in subjects with type 1 diabetes completing protocol 137-150. [ Time Frame: participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available ]

Eligibility Criteria

Information from the National Library of Medicine

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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:

  • The subject has completed the full dosing period in Protocol 137-150.
Contacts and Locations

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): NCT00107107


  Show 25 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00107107     History of Changes
Other Study ID Numbers: 137-150E
First Posted: April 6, 2005    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: August 2015

Keywords provided by AstraZeneca:
Diabetes
Amylin
pramlintide
Symlin

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