None listed
Conditions
Interventions
Dutogliptin Type of group
dutogliptin 400 mg, once daily tablet
Sponsors
PHENOMIX CORPORATION,
Eligibility
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Have completed all required visits on a qualifying main phase 3 protocol (for example, visit 8 / Day 196 of PHXl: 149-PROT301 or other protocols). • Be under current treatment of type 2 diabetes mellitus according to the applicable main phase 3 protocol. • For men and women with reproductive potential; Willingness to use an appropriate contraceptive method and not to get pregnant (or get pregnant with your partner (s)) throughout the course of the study. Suitable contraceptive measures include oral contraceptives (stable use for 2 cycles or more before pre-selection); IUD; Depo-Provera®; Norplant® System implants; bilateral tubal ligation; vasectomy; condom or diaphragm in addition to sponge, foam or contraceptive gel; and abstinence. • Who wish to return for all clinical visits and complete all procedures related to the study, including glycemia self-monitoring up to 5 times per week. • That they are able to understand and grant informed consent.
Exclusion criteria
Exclusion criteria: • With the exception of Type 2 diabetes, any other serious and uncontrolled pulmonary, cardiovascular, hematological, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric or urogenital disorder, or diseases of the skin and its annexes, the eyes, ears, nose or throat. • Any clinically relevant laboratory condition, disease, disorder or abnormality that, at the discretion of the investigator, could jeopardize the adequate participation of the patient in the present study or cover up the effects of the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Fasting HbA1c and glycemia and the change from baseline calculated throughout the study will be evaluated. The change in the value of HbA1c and fasting blood glucose will be determined using the last visit of one of the main protocols of which the subject was enrolled in the PRGT300E (such as PHX1149-PROT301, Day 196) as the baseline value . Measure:Variation in HbA1c levels Timepoints:2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Fasting blood glucose and the change from baseline calculated throughout the study will be evaluated. The change in fasting blood glucose will be determined using the last visit of one of the main protocols of which the subject was enrolled in the PRGT300E (such as PHX1149-PROT301, Day 196) as the baseline value. Measure:Variation in fasting blood glucose value. Timepoints:2 years | — |
Countries
Argentina, India, Malasya, Peru, Philippines, Romania, Ukraine, United States
Contacts
Public ContactLucero Nuñez
INC Research Peru S.A.C
Outcome results
None listed