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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00107107
First received: April 5, 2005
Last updated: June 19, 2015
Last verified: June 2015
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 1
Drug: pramlintide acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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:
  • 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 ]

Enrollment: 190
Study Start Date: November 2002
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Plaebo
Placebo solution is the same sterile preserved formulation, without the active ingredient, pramlintide.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject has completed the full dosing period in Protocol 137-150.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107107

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

No publications provided by AstraZeneca

Additional 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
Study First Received: April 5, 2005
Last Updated: June 19, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Diabetes
Amylin
pramlintide
Symlin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Islet Amyloid Polypeptide
Pramlintide
Anti-Obesity Agents
Appetite Depressants
Central Nervous System Agents
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on August 31, 2015