A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of SYR110322 (SYR-322) in Subjects with Type 2 Diabetes
- Conditions
- Type II diabetes mellitus.
- Registration Number
- EUCTR2005-004672-20-CZ
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 500
In order to be eligible for this study, each of the following criteria must be satisfied with a YES” answer (unless not applicable):
• Males or females with type 2 diabetes mellitus who were enrolled in one of the 5 controlled Phase III studies. The study will be open to all subjects who either completed one of these studies through the end-of-treatment visit or who were rescued
• Alanine aminotransferase =3 x upper limit of normal and serum creatinine =2.0 mg/dL. (However, if the approved product labeling for a concomitant antidiabetic medication warrants a more restrictive approach, this should be followed.)
• Neither pregnant (confirmed by laboratory testing in females of childbearing potential) nor lactating
• Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception. Methods of adequate contraception include the following: intrauterine device; doublebarrier device such as a diaphragm or condom plus spermicide; or a hormonal contraceptive (including injectable, implantable, or oral). Adequate contraception must be practiced for the duration of participation in the study
• Able and willing to monitor their own blood glucose concentrations with a home glucose monitor
• No major illness or debility that in the investigator’s opinion prohibits the subject from completing the study
• Able and willing to provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
In order to be eligible for this study, each of the following criteria must be satisfied with a NO” answer:
• The occurrence of any adverse event or condition during the controlled Phase III studies, that, in the opinion of the investigator, should exclude the subject from participating in the open-label extension
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To evaluate the safety of SYR-322 administered alone or in combination with a sulfonylurea, metformin, a thiazolidinedione, or insulin by evaluating adverse events (AEs), clinical laboratory parameters, electrocardiogram (ECG) readings, vital sign measurements, oral temperature, physical examinations, and hypoglycemic events;Secondary Objective: • To investigate the durability of glycemic control of SYR-322 administered alone or in combination with a sulfonylurea, metformin, a thiazolidinedione, or insulin;Primary end point(s):
- Secondary Outcome Measures
Name Time Method