Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics

Randomized Study to Evaluate the Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetic Subjects

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00698230

Enrollment

302

Registered

2008-06-17

Start date

2008-05-31

Completion date

2009-05-31

Last updated

2018-02-14

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 INCB013739 administered as an 'add-on' to metformin therapy in type 2 diabetic subjects on safety and tolerability and glycemic control.

Interventions

DRUGINCB013739

INCB013739 5 mg QD tablet

DRUGPlacebo comparator matching INCB013739

Orally once daily tablet

DRUGMetformin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Established diagnosis of Type 2 Diabetes * Stable dose of metformin for more than 8 weeks

Exclusion criteria

* Subjects with Addison's disease or Cushing's Syndrome * Type 1 diabetes mellitus or secondary forms of diabetes * Subjects with uncontrolled thyroid disease * History of renal impairment

Design outcomes

Primary

Measure	Time frame
Change from Baseline to Week 12 in hemoglobin A1c (HbA1c)	Baseline and Week 12 (or early termination study visit)

Secondary

Measure	Time frame
Change from Baseline to Week 12 in fasting plasma glucose (FPG).	Baseline and Week 12 (or early termination study visit)

Countries

Puerto Rico, United States

Outcome results

None listed

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