Evaluation of the Effect on Glucose Control of AC2993 in... | NCT00035984

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

Arm Groups

Label	Type	Description	Intervention Names
AC2993 5 mcg (0.02 mL)	Experimental	Placebo, then AC2993 5 mcg, then AC2993 5 mcg	Drug: AC2993
AC2993 10mcg (0.04 mL)	Experimental	Placebo, then AC2993 5 mcg, then AC2993 10 mcg	Drug: AC2993
Placebo 0.02 mL	Placebo Comparator	Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL	Drug: Placebo
Placebo 0.04 mL	Placebo Comparator	Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.04 mL	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AC2993	Drug	Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily	AC2993 5 mcg (0.02 mL)

Outcomes Module

Measure	Description	Time Frame
Change in HbA1c from Baseline to Week 30	Change in HbA1c from Baseline (Day 1) to study termination (Week 30)	Baseline (Day 1) to Week 30

Secondary Outcomes

Measure	Description	Time Frame
Change in HbA1c from baseline (Day 1) to each of the intermediate visits	Change in HbA1c from baseline, measured from Visit 3 (Day 1) to each of the intermediate visits (Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, and Week 24)	Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Pinnacle Research Group		Anniston	Alabama	36207	United States
Parkway Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15855571	Result	Kendall DM, Riddle MC, Rosenstock J, Zhuang D, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care. 2005 May;28(5):1083-91. doi: 10.2337/diacare.28.5.1083.
22913891	Derived

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
D003920	Diabetes Mellitus
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