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Impact of Sitagliptin on Diabetes Mellitus in Japanese elderly patients

Impact of Sitagliptin on Diabetes Mellitus in Japanese elderly patients - SMILE STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000009332
Enrollment
10000
Registered
2012-11-15
Start date
2012-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2 Diabetes

Interventions

None listed

Sponsors

Japan Physicians Association
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patient of Type2 diabetes 2. The age between 65-90 years (Male and Female) 3. The patient who is insufficient glycemic control being diet and exercise therapy alone or, in combination with drug therapy 4. The patient who newly starts diabetes medical treatment with sitagliptin

Exclusion criteria

Exclusion criteria: 1. The patient who has an anamnesis of sitaglitin allergy 2. The patient who has used incretin related drug in the past 3 month 3. The patient who has severe ketosis, diabetic coma or pre coma in the past 6 month 4. The patient has severe infection, before or after operation or severe external injury 5. The patient who has severe renal dysfanction 6. The patient of Type1 diabetes 7. The patient who is undertaking with glinide class 8. The patient is not allowed to this study by attending physician

Design outcomes

Primary

MeasureTime frame
HbA1c GA Side effect, complication and its incidence rate

Secondary

MeasureTime frame
Weight, Blood pressure, Fasting plasma glucose, Compliance of diet therapy, Compliance of exercise therapy, Dose of sitagliptin, Concomitant drug for diabetic treatment, Reason for change agents, Concomitant drug for complication, GOT(AST), GPT(ALP), gammaGTP, U-Cre, U-Alb, Urine protein, Questionnaire

Countries

Japan

Contacts

Public ContactHiroki Takyama

Soiken Inc. Division of Clinical Study Support

takayama@soiken.com03-3295-1350

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026