Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

A Phase Ib, Randomized, Open-Label, Multi-Center, 4-Week Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798264
• Other study ID #: ITCA 650-CLP-01
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2013
• Last updated: April 5, 2013
• Start date: February 2009
• Est. completion date: May 2009

Study information

• Verified date: April 2013
• Source: Intarcia Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• type 2 diabetes >6 months

• stable diet & exercise, metformin, TZD or met + TZD HbA1c >6.5% <10.0%

Exclusion Criteria:

• prior treatment with exenatide

• history of pancreatitis

• history of medullary thyroid cancer or multiple endocrine neoplasia 2

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• ITCA 650 (exenatide in DUROS)

Locations

Country	Name	City	State
United States	Medpace Clinical Pharmacology Unit	Cincinnati	Ohio
United States	dGd Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Intarcia Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Study Drug-Related Adverse Events		4 weeks	No
Secondary	To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus	Change in HbA1c from baseline	4 weeks	No
Secondary	Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline		4 weeks	No
Secondary	Change in Weight From Baseline to 4 Weeks		4 weeks	No