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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00108004
First received: April 12, 2005
Last updated: May 20, 2015
Last verified: May 2015

April 12, 2005
May 20, 2015
April 2003
June 2005   (final data collection date for primary outcome measure)
  • To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.
  • Understand management issues in subjects with type 1 and type 2 diabetes mellitus [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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
Not Provided
Complete list of historical versions of study NCT00108004 on ClinicalTrials.gov Archive Site
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Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 1 Diabetes Mellitus
  • Type 2 Diabetes Mellitus
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.
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

Intervention: Drug: pramlintide acetate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
June 2005
June 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00108004
137-155
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
AstraZeneca
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP