Evaluate the Safety and Tolerability of INCB019602 When Administered With Metformin in Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

A Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety and Tolerability of INCB019602 Plus Metformin Compared to Metformin Alone in Type 2 Diabetic Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00698789
• Other study ID #: INCB 19602-201
• Status: Terminated
• Phase: Phase 2
• First received: June 13, 2008
• Last updated: October 25, 2012
• Start date: May 2008
• Est. completion date: June 2009

Study information

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

Clinical Trial Summary

Determine the effect of treatment with INCB019602 administered as an add-on to stable dose metformin therapy in type 2 diabetic subjects on safety and glycemic control.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: June 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Established diagnosis of T2D

• Currently taking metformin monotherapy at a stable dose level

• FPG between 150 and 270 mg/dL

Exclusion Criteria:

• History or clinical manifestations of renal impairment

• Hyperglycemia > 270 mg/dL

• Receiving thiazolidenediones, Exenatide or sulfonylureas within 90 days prior to screening

• Prior use of Acipimox which is known under the name Olbetam within 90 days prior to screening.

• Diagnosed major depression within the last 2 years requiring hospitalization

• History of chronic insulin therapy for glycemic control

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• INCB019602
5 mg of INCB019602 in AM with placebo administration in PM
• INCB019602
20 mg in AM with placebo administration in PM
• INCB019602
5 mg in PM with placebo administration in AM
• INCB019602
20 mg in PM with placebo administration in AM
• INCB019602
7.5 mg in PM QoD with placebo administration in AM as well as PM on non-active dose days
• Placebo
Placebo administration in AM or PM depending on treatment arm dosing regimen.
• Metformin
Stable dose metformin monotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability as determined by monitoring of AEs, vital signs, ECGs, physical examinations, and clinical laboratory blood and urine parameters.		End of Study	No
Secondary	Change from Baseline in fasting plasma glucose and population pharmacokinetics of INCB019602 in type 2 diabetic patients.		End of Study	No