Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes mellitus
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Ono Pharmaceutical Co. Ltd
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written consent obtained 2. Aged \> = 20 years 3. Diagnosed with type 2 diabetes mellitus 4. Initiating a second oral or parenteral anti-diabetic therapy added to oral anti-diabetic monotherapy or switching from the monotherapy to another monotherapy with different drug class
Exclusion criteria
1. Diagnosis of Type 1 Diabetes Mellitus 2. Current pregnancy 3. Current treatment for any cancer 4. Current dialysis treatment or renal transplantation 5. Current treatment with any oral steroids 6. Participation in any randomized control trials 7. Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker who does not understand the local language where interpreter are not available, psychiatric disturbances, alcohol or drug abuse).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Classes of diabetic medications at baseline and changes up to 3 years | At 6, 12, 24, 36 month from enrollment | Classes of anti-diabetic medications at baseline and any changes of anti-diabetic medications during 3 years follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose level change from baseline | At 6, 12, 24, 36 month from enrollment | 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. |
| Body weight change from baseline | At 6, 12, 24, 36 month from enrollment | Overall and by second line anti-diabetic medication class, treatment response in terms of changes in body weight. |
| Blood pressure change from baseline | At 6, 12, 24, 36 month from enrollment | Overall and by second line anti-diabetic medication class, treatment response in terms of changes in blood pressure from baseline. |
| Lipid profile changes from baseline | At 6, 12, 24, 36 month from enrollment | Overall and by second line anti-diabetic medication class, treatment response in terms of changes in lipid profile |
| Incidence of microvascular complications | At 6, 12, 24, 36 month from enrollment | 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. |
| Hypoglycemia events | At 6, 12, 24, 36 month from enrollment | Overall and by second line anti-diabetic medication class, hypoglycemic events and hyperglycermia hospitalizations |
| Hemoglobin A1c change from baseline, Achievement rate of HbA1c and blood glucose target goals | At 6, 12, 24, 36 month from enrollment | 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 |
| Initiation of insulin therapy, Proportion of patients using insulin | At 6, 12, 24, 36 month from enrollment | Initiation of insulin therapy (e.g., reporting the average number of anti-diabetic therapies prescribed as insulin therapy is initiated and dose of insulin) |
| Switching of anti-diabetic medications or dose change | At 6, 12, 24, 36 month from enrollment | Switching of anti-diabetic medications or dose change |
| Initiation of third line or above add-on anti-diabetic medications | At 6, 12, 24, 36 month from enrollment | 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) |
| Incidence of macrovascular complications | At 6, 12, 24, 36 month from enrollment | Overall and by second line anti-diabetic medication class, disease progression in terms of macrovascular complications (heart failure, myocardial infarction and stroke). |
| Risk factors | At 6, 12, 24, 36 month after enrollment | 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 |
| Treatment choice | At baseline | Determinants of treatment choice |
| Patient reported Quality of Life, diet, and physical activity level | At 6, 12, 24, 36 month from enrollment | Overall and by second line anti-diabetic medication class, patient reported Quality of Life, diet, and physical activity level |
Countries
Japan
Outcome results
None listed