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Combination-effect of alogliptin and lansoprazole on glycemic contol in patients with type 2 diabetes-multicenter, randomized -controlled trial (APPLE study)

Combination-effect of alogliptin and lansoprazole on glycemic contol in patients with type 2 diabetes-multicenter, randomized -controlled trial (APPLE study) - Combination-effect of alogliptin and lansoprazole (APPLE study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009445
Enrollment
100
Registered
2012-12-01
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

type 2 diabetes

Interventions

3 months-observation by alogliptin treatment 3 months-observation by combination treatment with alogliptin and lansoprazole

Sponsors

Dokkyo Medical University Koshigaya Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) patients aged 20 or over 2) patients diagnosed as type 2 diabetes 3)outpatient 4)patients with 6.5% and over of HbA1c levels, and plus, with 0.5% or less variation of HbA1c in 1 month before starting administration of drugs 5)patients who did not receive DPP4 inhibitors during 1 month before starting study 6) patients in whom type and dose of all anti-diabetic drugs was not changed during 1 month before starting study 7)patients giving consent in writing for participation for this study

Exclusion criteria

Exclusion criteria: 1)Patients with severe ketosis, diabetic coma or diabetic pre-coma, or type 1 diabetes 2)Patients with severe infectious diseases, within 1 month after operation, or having severe traumatic injury 3)Patients with allergy for component of alogliptin or lansoprazole 4)Patients under atazanavir-treatment 5)Patients treated with PPIs of all types or H2-blockers of all types 6)Furthermore, patients judged as inadequacy for participation in this study by medical doctor

Design outcomes

Primary

MeasureTime frame
HbA1c and fasting plasma glucose (FPG) levels 3 months after starting the study

Secondary

MeasureTime frame
Fasting gastrin and insulin levels, HOMA-R, HOMA-beta, Body weight 3 months after starting the study

Countries

Japan

Contacts

Public ContactKohzo Takebayashi

Dokkyo Medical University Koshigaya Hospital Internal Medicine (Diabetes, Endocrinology,Hematology)

takebaya@dokkyomed.ac.jp048-965-1111

Outcome results

None listed

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