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-LV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 2200
In order to be eligible for this study, each of the following criteria must be satisfied with a YES” answer (unless not applicable):
1. Males or females with type 2 diabetes mellitus who were enrolled in one of the 7 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.
2. Alanine aminotransferase =3 x upper limit of normal and serum creatinine =2.0 mg/dL (=177 micromol/L). (However, if the approved product labeling for a concomitant antidiabetic medication warrants a more restrictive approach, this should be followed.)
3. Neither pregnant (confirmed by laboratory testing in females of childbearing potential) nor lactating.
4. 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.
5. Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
6. No major illness or debility that in the investigator’s opinion prohibits the subject from completing the study.
7. 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:
1. The occurrence of any adverse event or condition during the controlled Phase III studies, which, 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
- Secondary Outcome Measures
Name Time Method