Study of the Long-Term Safety of Pramlintide in Subjects... | NCT00107107 | Trialant

Study of the Long-Term Safety of Pramlintide in Subjects... | NCT00107107 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pramlintide Acetate	Active Comparator	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18715216	Derived	Kovatchev BP, Crean J, McCall A. Pramlintide reduces the risks associated with glucose variability in type 1 diabetes. Diabetes Technol Ther. 2008 Oct;10(5):391-6. doi: 10.1089/dia.2007.0295.

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases