Study to Examine the Effect on Glucose Control and Safety... | NCT00111540

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Exenatide	Experimental	Exenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination	Drug: exenatide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exenatide	Drug	subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination	Exenatide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit	Change in HbA1c from Visit 1 to each visit up to open-ended study termination	Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Change in body weight from Visit 1 to each protocol visit	Change in body weight (kg) from Visit 1 to each visit up to open-ended study termination	Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Change in fasting plasma glucose from Visit 1 to each protocol visit	Change in fasting plasma glucose from Visit 1 to each visit up to open-ended study termination	Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)
Change in lipids from Visit 1 to each protocol visit	Change in lipids from Visit 1 to each visit up to open-ended study termination	Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Lisa Porter, MD	Amylin Pharmaceuticals, LLC.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama		United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16776751	Result	Blonde L, Klein EJ, Han J, Zhang B, Mac SM, Poon TH, Taylor KL, Trautmann ME, Kim DD, Kendall DM. Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes. Diabetes Obes Metab. 2006 Jul;8(4):436-47. doi: 10.1111/j.1463-1326.2006.00602.x.
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Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D014688	Venoms
D045424	Complex Mixtures
D014118	Toxins, Biological
D001685	Biological Factors