An observational study in Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Completed at 107 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-02-07.
Sponsored by AstraZeneca · Observational
This study is intended to prospectively research the treatment reality and long-term disease control of Type 2 Diabetes Mellitus (T2DM) patients who are initiating 2nd line anti-diabetes treatment in sites across Japan.
This study is a single country, multicenter, observational, prospective, longitudinal cohort study which will include adult patients with documented history of T2DM who are initiating a second line oral or parenteral anti-diabetes mediation after their first line anti-diabetic therapy in real world setting. The follow-up period is 3 years. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. Patients will not receive experimental intervention or experimental treatment as a consequence of their participation in the study.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 1,869 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients with documented history of type 2 diabetes mellitus who are initiating their second line oral or parenteral anti-diabetics medication after first line oral diabetic therapy
Exclusion Criteria:
Adult patients with documented history of type 2 diabetes mellitus who are initiating their second line oral or parenteral anti-diabetics medication after first line oral diabetic therapy
Classes of diabetic medications at baseline and changes up to 3 years
Classes of anti-diabetic medications at baseline and any changes of anti-diabetic medications during 3 years follow-up period.
Time frame: At 6, 12, 24, 36 month from enrollment
Hemoglobin A1c change from baseline, Achievement rate of HbA1c and blood glucose target goals
Overall and by second line anti-diabetic medication class, treatment response in terms of changes in HbA1c from baseline, achievement rate of HbA1c and blood glucose target goals
Time frame: At 6, 12, 24, 36 month from enrollment
Blood glucose level change from baseline
Overall and by second line anti-diabetic medication class, treatment response in terms of changes in blood glucose level (FPG or CPG or PPG) from baseline.
Time frame: At 6, 12, 24, 36 month from enrollment
Body weight change from baseline
Overall and by second line anti-diabetic medication class, treatment response in terms of changes in body weight.
Time frame: At 6, 12, 24, 36 month from enrollment
Blood pressure change from baseline
Overall and by second line anti-diabetic medication class, treatment response in terms of changes in blood pressure from baseline.
Time frame: At 6, 12, 24, 36 month from enrollment
Lipid profile changes from baseline
Overall and by second line anti-diabetic medication class, treatment response in terms of changes in lipid profile
Time frame: At 6, 12, 24, 36 month from enrollment
Incidence of microvascular complications
Overall and by second line anti-diabetic medication class, disease progression in terms of microvascular complications: incidence of chronic nephropathy, dialysis, diabetic retinopathy, retinal photocoagulation, amputation of lower extremity, diabetic foot, peripheral nerve disorders, autonomic nervous system disorders and erectile dysfunction.
Time frame: At 6, 12, 24, 36 month from enrollment
Hypoglycemia events
Overall and by second line anti-diabetic medication class, hypoglycemic events and hyperglycermia hospitalizations
Time frame: At 6, 12, 24, 36 month from enrollment
Patient reported Quality of Life, diet, and physical activity level
Overall and by second line anti-diabetic medication class, patient reported Quality of Life, diet, and physical activity level
Time frame: At 6, 12, 24, 36 month from enrollment
Initiation of insulin therapy, Proportion of patients using insulin
Initiation of insulin therapy (e.g., reporting the average number of anti-diabetic therapies prescribed as insulin therapy is initiated and dose of insulin)
Time frame: At 6, 12, 24, 36 month from enrollment
Switching of anti-diabetic medications or dose change
Switching of anti-diabetic medications or dose change
Time frame: At 6, 12, 24, 36 month from enrollment
Initiation of third line or above add-on anti-diabetic medications
Initiation of third line or above add-on anti-diabetic medication (e.g., reporting proportion of patients receiving 2nd, 3rd, 4th or greater anti-diabetic therapies at each follow-up visit)
Time frame: At 6, 12, 24, 36 month from enrollment
Incidence of macrovascular complications
Overall and by second line anti-diabetic medication class, disease progression in terms of macrovascular complications (heart failure, myocardial infarction and stroke).
Time frame: At 6, 12, 24, 36 month from enrollment
Risk factors
Risk factors (patient characteristics at baseline: e.g. age, gender, duration of diabetes, presence of co-morbidities) associated with poorer clinical outcomes during follow-up
Time frame: At 6, 12, 24, 36 month after enrollment
Treatment choice
Determinants of treatment choice
Time frame: At baseline
Showing the first 100 of 107 sites.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AstraZeneca