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Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00108004
Recruitment Status : Completed
First Posted : April 13, 2005
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Drug: pramlintide acetate Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3B, Multicenter, Open-Label Study Investigating the Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Insulin Therapy
Study Start Date : April 2003
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pramlintide

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

Drug: pramlintide acetate
Pramlintide (0.6 mg/mL) in 5.0-mL multiple-draw glass vials for SC injection for 12weekes and after Pramlintide (1.0 mg/mL) 1.5 mL pen-cartridge. Subjects who do not switch to the pen-cartridge device at Week 12 will continue to administer pramlintide using a syringe and vial.




Primary Outcome Measures :
  1. To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus [ Time Frame: 6 months ]
    To investigate the clinical utility (change in HbA1c, seven-point glucose profile, body weight, and insulin use) and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy.

  2. Understand management issues in subjects with type 1 and type 2 diabetes mellitus [ Time Frame: 6 months ]
    To collect data regarding the selection of subjects for pramlintide administration by healthcare professionals and to further understand management issues in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy



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

Inclusion Criteria:

  • The subject has a clinical diagnosis of type 1 diabetes mellitus requiring treatment with insulin for a minimum of 6 months at Screening; -OR- The subject has a clinical diagnosis of type 2 diabetes requiring treatment with insulin with or without oral antidiabetic agents for a minimum of 6 months at Screening.
  • The subject has a HbA1c of 7.0% to 11.0% at Screening.

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): NCT00108004


  Show 48 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00108004     History of Changes
Other Study ID Numbers: 137-155
First Posted: April 13, 2005    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015

Keywords provided by AstraZeneca:
Diabetes
Amylin
Symlin
pramlintide acetate

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
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