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

Incyte

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: INCB013739; Drug: Placebo comparator matching INCB013739; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00698230

INCB 13739-202

Details and patient eligibility

About

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.

Enrollment: 302 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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302 participants in 6 patient groups, including a placebo group

Treatment A - INCB013739 & Metformin

Experimental group

Description:

INCB013739 5 mg QD and Metformin

Treatment:

Drug: INCB013739

Drug: INCB013739

Drug: INCB013739

Drug: Metformin

Drug: INCB013739

Drug: INCB013739

Treatment B - INCB013739 & Metformin

Experimental group

Description:

INCB013739 15 mg QD and Metformin

Treatment:

Drug: INCB013739

Drug: INCB013739

Drug: INCB013739

Drug: Metformin

Drug: INCB013739

Drug: INCB013739

Treatment C - INCB013739 & Metformin

Experimental group

Description:

INCB013739 50 mg QD and Metformin

Treatment:

Drug: INCB013739

Drug: INCB013739

Drug: INCB013739

Drug: Metformin

Drug: INCB013739

Drug: INCB013739

Treatment D - INCB013739 & Metformin

Experimental group

Description:

INCB013739 100 mg QD and Metformin

Treatment:

Drug: INCB013739

Drug: INCB013739

Drug: INCB013739

Drug: Metformin

Drug: INCB013739

Drug: INCB013739

Treatment E - INCB013739 & Metformin

Experimental group

Description:

INCB013739 200 mg QD and Metformin

Treatment:

Drug: INCB013739

Drug: INCB013739

Drug: INCB013739

Drug: Metformin

Drug: INCB013739

Drug: INCB013739

Treatment F - Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo comparator matching INCB013739