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A clinical study of the correlation between QOL and the effects of oral anti-diabetic drugs on newly treated patients with type2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006986
Enrollment
800
Registered
2012-01-04
Start date
2012-01-01
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

Group 1 taking single administration of DPP-4 inhibitor Start with the basic dose determined by each clinic Changing dose and administration should be determined by the doctor in charge Treatment peri

Sponsors

QOL study group for oral anti-diabetic agent
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Newly treated with any oral anti-diabetic drugs and inadequate glycemic control(HbA1c 6.5-9.0%[the JDS]/6.9-9.4%6.9-9.4%[the NGSP] in spite of diet and exercise therapy for over 4 weeks 2)Age of 20<=, 80> 3)Out patients of either gender 4)Patients who agree to participate in the study, and who are able to start in 12 weeks

Exclusion criteria

Exclusion criteria: 1)type1 diabetes(CPR blood test and anti-GAD test is recommended) 2)Taking any anti-diabetic drugs 3)Severe ketosis, precoma, diabetic coma 4)Hepatic dysfunction(ALT <= 3times the upper limit of normal) 5)Gastrointestinal dysfunction as diarrhea or vomiting 6)Severe infection, severe injury. Before and after accepting surgery 7)Pregnant or suspected to be pregnant 8)History of hypersensitivity to any component of testing drugs 9)History of cancer or being treated for cancer 10)Whom the doctor in charge decided not to be appropriate for this study on the point of medical reason

Design outcomes

Primary

MeasureTime frame
Scores in QOL questionnaire at 4th week

Secondary

MeasureTime frame
Scores in QOL questionnaire at 12th week Analyses of each item score in the questionnaire for each drug Analyses of intra-class correlation in the questionnaire for each drug The changing rate of HbA1c for each drug Completion rate for each drug treatment Patient adherence to each drug

Countries

Japan

Outcome results

None listed

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