Type 2 Diabetes, Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, DPP4 inhibitor, dutogliptin, PHX1149
Brief summary
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.
Detailed description
In this study, open-label dutogliptin/PHX1149T will be offered to subjects who complete a Phase 3 core protocol and wish to continue treatment with dutogliptin. This will allow for the collection of long-term safety data and will also demonstrate long-term effects on HbA1c and fasting blood glucose.
Interventions
DRUGdutogliptin
dutogliptin 400 mg, once daily tablet
Sponsors
Forest Laboratories
Phenomix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Completion of all required visits of a qualifying Phase 3 core protocol (e.g., Visit 8/Day 196 of PHX1149-PROT301) * Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT301
Exclusion criteria
* Except for Type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat * 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
| Measure | Time frame |
|---|---|
| To demonstrate safety and tolerability of dutogliptin | Two years |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate maintenance or lowering of HbA1c | Two years |
| To demonstrate maintenance or lowering of fasting blood glucose | Two years |
Countries
Argentina, India, Malaysia, Peru, Philippines, Romania, Ukraine, United States
Outcome results
None listed