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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

A Phase III, Multicenter, Double-blind, Active-Controlled, 52 Week Extension Study to Evaluate the 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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01089790
Acronym
REDWOOD403
Enrollment
141
Registered
2010-03-19
Start date
2010-03-31
Completion date
Unknown
Last updated
2011-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief summary

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

Interventions

DRUGDutogliptin

400 mg tablet, once daily

DRUGSitagliptin

100 mg capsule (each capsule contains two 50-mg tablets), once daily

Sponsors

Phenomix
CollaboratorINDUSTRY
Forest Laboratories
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 86 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG52 weeks

Secondary

MeasureTime frame
To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose.52 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026