UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010880 |
|---|---|
| Receipt number | R000012735 |
| Scientific Title | Effect of Linagliptin on daily glucose excursion in Continuous Glucose Monitoring of Type2 diabetic patients |
| Date of disclosure of the study information | 2013/06/05 |
| Last modified on | 2018/06/11 11:22:19 |
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Basic information
Public title
Effect of Linagliptin on daily glucose excursion in Continuous Glucose Monitoring of Type2 diabetic patients
Acronym
L-CGM
Scientific Title
Effect of Linagliptin on daily glucose excursion in Continuous Glucose Monitoring of Type2 diabetic patients
Scientific Title:Acronym
L-CGM
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been no reported that the studies in the circadian glycemic profile of Linagliptin using continuous glucose monitoring (CGM) in Japanese Type 2 diabetic patients. In this clinical study, we investigate whether Linagliptin, the first biliary excreted type selective DPP-4 inhibitor (1 dose), improves the change of mean 24 hours glucose level at the point of 12 weeks from Baseline in comparison with Alfa-glycosidase inhibitor that has been in use for many years as first-line treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of mean 24 hours glucose level at the point of 12 weeks from Baseline
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A; patients who take Linagliptin
Interventions/Control_2
Group B; patients who take Voglibose
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 with type 2 diabetes have not been taken antidiabetic medication more than 12 week.
2.7.4% and higher -HbA1c- under 10% (NGSP) at screening.
3.18 over - BMI under 30
4.eGFR,45 or higher
5.Twenty years of age or older, regardless of gender
6.Written consent for participation in the study
Key exclusion criteria
1.Type 1 and secondary diabetes
2.Severe infectious disease, before or after surgery, and severe trauma
3.Events of myocardial infarction, cerebral stroke, cerebral infarction and TIA in the past 3 month.
4.Moderate or severer heart failure(NYHA/New York Heart Association stage III or severer)
5.Severe liver dysfunction (ALT,AST and ALP face 3 times the normal level)
6.Past medical history of hypersensitivity to investigational drugs.
7.Patients addicted to alcohol and drugs.
8.Pregnant, lactating, and possibly pregnant women and those planning to become pregnant.
9.Patients with cancer.
10.Patent receiving steroid therapy with inflammatory affection.
11.Past medical history of abdominal operation and ileus.
12.Judged as ineligible by clinical investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIROAKI SATOH |
Organization
Fukushima Medical University
Division name
Department of Nephrology, Hypertension, Diabetology, Endocrinology, and Metabolism
Zip code
Address
1 Hikarigaoka Fukushima-city, Fukushima, 960-1295, Japan
TEL
024-547-1206
hiroakis-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Takyama |
Organization
Soiken.inc
Division name
Division of clinical study support
Zip code
Address
NBF OGAWAMACHI BUILDING 4F, 1-3-1,Kanda Ogawamachi, Chiyoda-ku, Tokyo
TEL
03-3295-1350
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
Japan society of Patient Reported Outcome
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co ., Ltd and Eli Lilly Japan K.K
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2013 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 05 | Day |
Last modified on
| 2018 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012735
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