Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Glimepiride With or Without Metformin

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background therapy of glimepiride with or without metformin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Collaborator: Phenomix
• Treatments: Glimepiride; Metformin

Criteria

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 on 3 or more oral antidiabetic drugs or insulin.

• Type 1 diabetes mellitus