Type 2 Diabetes
Conditions
Interventions
Intervention type:
Name of intervention:
Dose form / Japanese Medical Device Nomenclature:
Route of administration / Site of application:
Dose per administration:
Dosing frequency / Frequency of use:
Sponsors
Nagoya Medical Association
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Japanese patients with type 2 diabetes who are conducted with diet and/or exercise therapy satisfying the following criteria (1)-(4) (1) Above 20 years old, regardless of sex (2)Patients with the variation of HbA1c should be => 6.5% and =<10% (JDS) at the start of sitagliptin administration(for around 2 months between the time obtaining the informed consent and the start of sitagliptin administration). (3)Patients satisfying one of the following criterions (a)-(b). (a) Patients who never experienced with an oral hypoglycemic agents. (b)Patients who received biguanide,thiazolidinedione,sulfonylureas,alpha-GI,or insulin at the constant dose for 4 weeks before sitagliptin administration. ( In case of the concomitant use of sulfonylureas, patients who received sulfonylureas consulting the " Recommendation of the committee for proper use of Incretin and sulfonylureas ". ) (4) Patients who got informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with a history of hypersensitivity to any components of this type of drug. (2) Patients with severe ketosis, diabetic coma or precoma, or Type 1 diabetes mellitus. (3) Patients with moderate renal impairment. (sCr: >=1.5 mg/dl ) (4) Patients with severe infections, before or after operation, or with serious trauma. (5) Patients who receive glinide. (6) Females who are pregnant, who intend to become pregnant or who is nursing. (7) Patients disqualified participating this trial by doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c change from baseline at 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Normalization rate of HbA1c and FBG, and HOMA-B, body weight and serum lipid at the starting point 3, 6 12 months. | — |
Countries
Japan
Contacts
Public ContactHiroyuki Mizuta
Nagoya Medical Association
Outcome results
None listed