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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009445
Receipt No. R000011094
Scientific Title Combination-effect of alogliptin and lansoprazole on glycemic contol in patients with type 2 diabetes-multicenter, randomized -controlled trial (APPLE study)
Date of disclosure of the study information 2012/12/01
Last modified on 2017/06/28

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Basic information
Public title Combination-effect of alogliptin and lansoprazole on glycemic contol in patients with type 2 diabetes-multicenter, randomized -controlled trial (APPLE study)
Acronym Combination-effect of alogliptin and lansoprazole (APPLE study)
Scientific Title Combination-effect of alogliptin and lansoprazole on glycemic contol in patients with type 2 diabetes-multicenter, randomized -controlled trial (APPLE study)
Scientific Title:Acronym Combination-effect of alogliptin and lansoprazole (APPLE study)
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate combination-effect of alogliptin and lansoprazole on glycemic contol in patients with type 2 diabetes using multicenter, randomized -controlled trial-design
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes HbA1c and fasting plasma glucose (FPG)
levels 3 months after starting the study
Key secondary outcomes Fasting gastrin and insulin levels, HOMA-R, HOMA-beta, Body weight 3 months after starting the study

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 3 months-observation by alogliptin treatment
Interventions/Control_2 3 months-observation by combination treatment with alogliptin and lansoprazole
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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
Key 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

Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohzo Takebayashi
Organization Dokkyo Medical University Koshigaya Hospital
Division name Internal Medicine (Diabetes, Endocrinology,Hematology)
Zip code
Address 2-1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
TEL 048-965-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kohzo Takebayashi
Organization Dokkyo Medical University Koshigaya Hospital
Division name Internal Medicine (Diabetes, Endocrinology,Hematology)
Zip code
Address 2-1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
TEL 048-965-1111
Homepage URL
Email takebaya@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University Koshigaya Hospital
Institute
Department

Funding Source
Organization Dokkyo Medical University Koshigaya Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 獨協医科大学越谷病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2012 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 01 Day
Last follow-up date
2013 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 11 Month 30 Day
Last modified on
2017 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011094

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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