UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039460 |
|---|---|
| Receipt number | R000044993 |
| Scientific Title | Effect of switching from a combination therapy using DPP-4 inhibitor and insulin degludec to insulin degludec/liraglutide on blood glucose fluctuation in patients with type 2 diabetes |
| Date of disclosure of the study information | 2020/02/11 |
| Last modified on | 2023/05/10 13:05:37 |
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Basic information
Public title
Effect of switching from a combination therapy using DPP-4 inhibitor and insulin degludec to insulin degludec/liraglutide on blood glucose fluctuation in patients with type 2 diabetes
Acronym
Effect of switching from a combination therapy using DPP-4 inhibitor and insulin degludec to insulin degludec/liraglutide on blood glucose fluctuation in patients with type 2 diabetes
Scientific Title
Effect of switching from a combination therapy using DPP-4 inhibitor and insulin degludec to insulin degludec/liraglutide on blood glucose fluctuation in patients with type 2 diabetes
Scientific Title:Acronym
Effect of switching from a combination therapy using DPP-4 inhibitor and insulin degludec to insulin degludec/liraglutide on blood glucose fluctuation in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of switching from DPP-4 inhibitor and insulin degludec to insulin degludec/liraglutide on glucose fluctuation in patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of mean amplitude of glycemic excursions (MAGE) before and after switching of treatment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with type 2 diabetes who were hospitalized in Hokkaido University Hospital from February 2020 to December 2021.
2) 20-80 years old
3) HbA1c >= 6.5%
4) Patients who have been treated with combination therapy using DPP-4 inhibitor and insulin degludec (<=16 unit/day) for more than 3 days with stable blood glucose condition
5) Treatment with degludec/liraglutide will be appropriate to achieve preferable glycemic control
6) Agreement to participate to this study
Key exclusion criteria
1) History of anaphylaxis of insulin degludec or liraglutide
2) Unstable glycemic control
3) Severe hepatic dysfunction, renal dysfunction
4) Pregnancy
5) Diabetic ketosis, coma and precoma
6) Serious infection, pre-or post-surgery
7) Poor adherence to dietary therapy
8) Poor insulin secretion
9) Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nomoto |
Organization
Hokkaido University Hospital
Division name
Department of Internal Medicine II
Zip code
060-0811
Address
North 15 West 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
hnomoto@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nomoto |
Organization
Hokkaido University Hospital
Division name
Department of Internal Medicine II
Zip code
060-0811
Address
North 15 West 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
Homepage URL
hnomoto@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Clinical Research Management Department
Address
North 14, West 5, Kita-ku, Sapporo, Hokkaido, Japan
Tel
011-706-7636
crjimu@med.hokudai.ac.jp
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 11 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35097130/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35097130/
Number of participants that the trial has enrolled
15
Results
Switching from DPP-4 inhibitor plus insulin degludec to IDegLira significantly improved MAGE from 74.9 (60.3, 97.7) mg/dL to 64.8 (52.0, 78.2) mg/dL (P < 0.05), as well as other indices of GV and 24-hour mean blood glucose concentration.
Results date posted
| 2023 | Year | 05 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We recruited hospitalized patients with type 2 diabetes who had stable glycemic control with insulin degludec (within 16 units/day) and taking a DPP-4 inhibitor.
Participant flow
We recruited the patents who met the inclusion criteria and agreed to participate to this study.
Adverse events
None
Outcome measures
Refer to the section of "2.3. Continuous Glucose Monitoring" in the main paper.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 02 | Month | 11 | Day |
Last modified on
| 2023 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044993
