Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus Receiving Background Treatment With Glimepiride Alone or in Combination With Metformin or With Pioglitazone Alone (REDWOOD403)

Forest Laboratories

Status and phase: Terminated; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Dutogliptin; Drug: Sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01089790

DUT-MD-403

Details and patient eligibility

About

This study will evaluate the long-term safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM).

Enrollment: 141 patients

Sex: All

Ages: 18 to 86 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have successfully completed all required visits of a qualifying Phase 3 core protocol
• Be currently receiving treatment for T2DM as set forth in the qualifying Phase 3 core protocol

Exclusion criteria

• Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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141 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Dutogliptin

2

Active Comparator group

Treatment:

Drug: Sitagliptin