Clinical characteristics and practice patterns of type 2 diabetes mellitus (T2DM) patients treated with oral antidiabetic drugs (OAD) in Japan: analysis of medical and health care database of the Medical Data Vision (MDV)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10BA) Biguanides

  Biguanides

  (A10BB) Sulfonylureas

  Sulfonylureas

  (A10BF) Alpha glucosidase inhibitors

  Alpha glucosidase inhibitors

  (A10BG) Thiazolidinediones

  Thiazolidinediones

  (A10BH) Dipeptidyl peptidase 4 (DPP-4) inhibitors

  Dipeptidyl peptidase 4 (DPP-4) inhibitors

  (A10BX) Other blood glucose lowering drugs, excl. insulins

  Other blood glucose lowering drugs, excl. insulins
• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  Type 2 diabetes mellitus patients with renal impairment in clinical practice in Japan.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Diabetes mellitus patients
• Estimated number of subjects:
  40000

Study design details

• Main study objective:
  The primary objective of this study is to analyze the demographic and clinical characteristics of T2DM patients who have been treated with OADs.
• Outcomes:
  Demographic and clinical characteristics of patients who had a prescription of OADs. In case of comparing drugs within class, index date is defined as the date of first prescription for any study drugs as general name. Change of dosage is not counted as the index. Drug and dosage (based on daily dose) they are prescribed as there are different cut-offs for renal functions. In case of comparing drugs within class, index date is defined as the date of first prescription for any study drugs as general name. Change of dosage is not counted as the index.
• Data analysis plan:
  For the primary objective, descriptive statistics of each compound and each class of OAD will be presented for the baseline demographic and clinical characteristics.For the 2nd objective, survival curves for discontinuation during the observation period in each patients group will be compared among patient groups prescribed with different classes of OADs to estimate retention rate of each therapy.For the 3rd objective, survival curves for discontinuation during the observation period in moderate or severe RI patients group prescribed OADs will be analyzed, if the sample size is enough.