Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Pioglitazone

Forest Laboratories

Status and phase: Terminated; Phase 3

Conditions: Diabetes Mellitus, Type II

Treatments: Drug: Placebo; Drug: Dutogliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00970424

DUT-MD-304

Details and patient eligibility

About

This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background treatment with pioglitazone.

Enrollment: 252 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus, diagnosed at least 3 months prior to Screening (Visit 1)
• BMI 20 to 48 kg/m2, inclusive
• HbA1c 7.0% - 10.0%, inclusive
• Age 18 to 85 years, inclusive

Exclusion criteria

• Currently taking more than one oral hypoglycemic agent
• Type 1 diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

placebo, oral tablet administered once daily on background of pioglitazone

Treatment:

Drug: Placebo

2

Experimental group

Description:

dutogliptin, oral tablet administered once daily on background of pioglitazone

Treatment:

Drug: Dutogliptin