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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00698789

Enrollment

Registered

2008-06-17

Start date

2008-05-31

Completion date

2009-06-30

Last updated

2012-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief 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.

Interventions

DRUGINCB019602

5 mg of INCB019602 in AM with placebo administration in PM

DRUGPlacebo

Placebo administration in AM or PM depending on treatment arm dosing regimen.

DRUGMetformin

Stable dose metformin monotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability as determined by monitoring of AEs, vital signs, ECGs, physical examinations, and clinical laboratory blood and urine parameters.	End of Study

Secondary

Measure	Time frame
Change from Baseline in fasting plasma glucose and population pharmacokinetics of INCB019602 in type 2 diabetic patients.	End of Study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026