Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes

Pfizer

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: PF-04937319 - 100mg; Drug: PF-04937319 - 50mg; Drug: Sitagliptin - 100mg; Drug: PF-04937319 - 3mg; Drug: Placebo; Drug: PF-04937319 - 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01475461

2011-004002-25 (EudraCT Number)

B1621007

Details and patient eligibility

About

B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes

Enrollment: 345 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with type 2 diabetes, on metformin, age between 18-55 yrs, male or female

Exclusion criteria

• patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory test results at screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

345 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

PF-04937319 - Dose 1

Experimental group

Treatment:

Drug: PF-04937319 - 3mg

PF-04937319 - Dose 2

Experimental group

Treatment:

Drug: PF-04937319 - 20mg

PF-04937319 - Dose 3

Experimental group

Treatment:

Drug: PF-04937319 - 50mg

PF-04937319 - Dose 4

Experimental group

Treatment:

Drug: PF-04937319 - 100mg

Sitagliptin

Active Comparator group

Treatment:

Drug: Sitagliptin - 100mg