None listed
Conditions
Interventions
GROUP 1 Type of group
All the subjects of this group will continue with the basic medication they receive in their respective phase III trial (sulfonylurea, metformin, thiazolidinedione and insulin) + SYR-322, 25 mg PO QD until they conclude their participation in their respective Phase III trials.
Once the subjects conclude their participation in their respective Phase III trials, the dose of SYR-322 will be reduced to 12.5 mg PO QD while maintaining the corresponding base therapy. This scheme will continue for 2
All the subjects of this group will continue with the basic medication they receive in their respective phase III trial (sulfonylurea, metformin, thiazolidinedione and insulin) + SYR-322, 25 mg PO QD until they conclude their participation in their respective Phase III trials.
Once the subjects conclude their participation in their respective Phase III trials, the dose of SYR-322 will be reduced to 25 mg PO QD while maintaining the corresponding base therapy. This scheme will continue for 2 y
Sponsors
TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER, INC.,
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Men or women with type 2 diabetes mellitus who enrolled in one of the 5 controlled phase III studies. 2. Alanine aminotransferase ≤ 3 x of the upper limit of normal and serum creatinine ≤2.0 mg / dL. 3. Not being pregnant or nursing. 4. Women with potential to conceive should use the corresponding contraceptive method. 5. Be able and willing to monitor your own blood glucose levels with a home glucose monitor 6. Do not present major diseases or weakness that in the opinion of the researcher prohibit the subject to conclude the study. 7. Be able and willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1. The occurrence of any adverse event or condition during the phase III controlled studies that, in the opinion of the investigator, should exclude the subject from participating in the open label extension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation to evaluate adverse events (AEs), vital signs measurement, oral temperature, physical examinations. Hypoglycemic events: serum glucose Parameters of clinical laboratories: Panels of hematology, serum chemistry, urinalysis. Electrocardiogram (ECG) of 12 leads. Measure:Security of SYR-322. Timepoints:The measurements will be made when 400 patients have completed the treatment for 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1C, glucose, proinsulin, insulin, C-peptide: Laboratory tests will be obtained from fasting peripheral blood samples and will be processed in the central laboratory. Body weight: Body weight will be measured in kilograms. It should be measured without shoes and light street clothes, through a consistent scale. Clinical response: It will be measured by the pattern of HbA1C change over time. Measure:Efficiency of of SYR-322: HbA1C. Fasting plasma glucose. Proinsulin Insulin. Peptide C. Body weight. Incidence of marked hyperglycemia (fasting plasma glucose> 200 mg / dL). Incidence of clinical response. Timepoints:The measurements will be made when 400 patients have completed the treatment for 1 year. | — |
Countries
Argentina, Australia, Brazil, Chile, Czech Republic, Dominican Republic, Germany, Guatemala, India, Mexico, Netherlands, New Zealand, Poland, South Africa, Spain, United States
Outcome results
None listed