An Open Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety of PHX1149T/Dutogliptin in Subjects With Type 2 Diabetes Mellitus

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-066-09
• Date of registration: 04/09/2009
• Prospective Registration: Yes
• Primary sponsor: PHENOMIX CORPORATION,
• Public title: An Open Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety of PHX1149T/Dutogliptin in Subjects With Type 2 Diabetes Mellitus
• Scientific title: An Open Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety of PHX1149T/Dutogliptin in Subjects With Type 2 Diabetes Mellitus
• Date of first enrolment: 01/01/1900
• Target sample size: 90
• Recruitment status: Complete
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=066-09
• Study type: Interventional
• Study design: This will be an open, multicenter, long-term follow-up study to assess the safety of dutogliptin in subjects with type 2 diabetes mellitus. All subjects completing a main phase 3 study with dutogliptin (for example, PHXl 149- PROT301 or other protocols) will be eligible to participate in this extension protocol. Subjects will participate in the study for 52 weeks.
• Phase: III

Countries of recruitment

Argentina, India, Malasya, Peru, Philippines, Romania, Ukraine, United States

Contacts

• Name: Lucero Ferraro Nuñez
• Affiliation: INC Research Peru S.A.C

• Name: Lucero Ferraro Nuñez
• Affiliation: INC Research Peru S.A.C

Key inclusion & exclusion 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:
• 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.


Age minimum: 30
Age maximum: 75
Gender: --

Health Condition(s) or Problem(s) studied

E11

Non-insulin-dependent diabetes mellitus

-E11 Non-insulin-dependent diabetes mellitus
Non-insulin-dependent diabetes mellitus

Intervention(s)

Group name:Dutogliptin Type of group;1 N° of participants:1500 Intervention(s) description:dutogliptin 400 mg, once daily tablet

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

NCT00865592

Ethics review

Status: Approved
Approval date: 03/04/2009
Contact:

[e-mail] - [e-mail]

Universidad San Martin de Porres

999098514

[e-mail] - [e-mail]

Status: Approved
Approval date: 18/04/2009
Contact:

[e-mail]

Sociedad Peruana de Medicina Interna Filial Arequipa

054257142

[e-mail]