A Study to Evaluate ITCA 650 Compared to Glimepiride as Add on Therapy for the Treatment of Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01455922
• Other study ID #: ITCA 650-CLP-112
• Status: Withdrawn
• Phase: Phase 3
• First received: October 18, 2011
• Last updated: December 21, 2012
• Start date: February 2013
• Est. completion date: July 2014

Study information

• Verified date: December 2012
• Source: Intarcia Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• HbA1c between 7.5% - 10.5%

• on metformin monotherapy

• BMI between 25 & 45 kg/m2

Exclusion Criteria:

• On thiazolidinedione, sulfonylurea, DPP-4, alpha glucosidase inhibitor, meglitinides or insulin within last 3 months

• history of pancreatitis

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• ITCA 650
ITCA 650 is exenatide in DUROS
• glimepiride
glimepiride will be up-titrated to 8 mg/day over first 13 weeks

Locations

Country	Name	City	State
United States	Intarcia Therapeutics, Inc	Hayward	California

Sponsors (1)

Lead Sponsor	Collaborator
Intarcia Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	52-week Treatment Period followed by 52-week Extension Period	52 weeks	No