UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022531 |
|---|---|
| Receipt number | R000025968 |
| Scientific Title | The efficacy of switching from sulfonyl urea to repaglinide on glycemic control in elderly patients with type 2 diabetes |
| Date of disclosure of the study information | 2016/05/30 |
| Last modified on | 2020/10/29 16:59:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The efficacy of switching from sulfonyl urea to repaglinide on glycemic control in elderly patients with type 2 diabetes
Acronym
The effect of repaglinide on glycemic control in elderly patients with type 2 diabetes
Scientific Title
The efficacy of switching from sulfonyl urea to repaglinide on glycemic control in elderly patients with type 2 diabetes
Scientific Title:Acronym
The effect of repaglinide on glycemic control in elderly patients with type 2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of repaglinide on glucose metabolism,frequency of hypoglycemia,body weight in elderly patients with type 2 diabetes treating with sulfonylurea.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
Weight, BMI
Fasting plasma glucose, glicolalbumin,and 1.5-AG
Frequency of hypoglycemia
Blood pressure
Lipid metabolism
Liver function
Complete blood count, renal function, electrolyte
Dose of Sulfonylurea before and during clinical trial
Urine test
Questionnaires for adherence to drug medication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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
Keeping sulfonylureas
Interventions/Control_2
Switching from sulfonylureas to repaglinide
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Elderly patients with type 2 diabetes who have been taking sulfonylurea (Glimepiride/ Gliclazide/ Glibenclamide equal to or more than 1 mg /40 mg/1.25 mg per day ).
2)Age: 60 to 90 years old
3) BMI< 25 kg/m^2
4) HbA1c 7.0 to 9.0 %
5) Written informed consent
Key exclusion criteria
1)patients with hypersensitivity to repaglinide
2) patients with severe liver dysfunction
3)patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyoshi |
Organization
Hokkaido University Hospital
Division name
Department of Internal Medicine II
Zip code
Address
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
hmiyoshi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuno Omori |
Organization
Hokkaido University Hospital
Division name
Department of Internal Medicine II
Zip code
Address
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5915
Homepage URL
kazunoko@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
Organization
Division
Category of Funding Organization
Other
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
北海道大学病院（北海道）、沖病院（北海道）、栗原内科（北海道）、青木内科（北海道）、栗山赤十字病院（北海道）、北海道中央労災病院せき損センター（北海道）、萬田記念病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/29963781/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/29963781/
Number of participants that the trial has enrolled
57
Results
HbA1c was not significantly different between the two groups (SU +0.02% vs Repa -0.07%), while greater improvements in the glycated albumin (GA) and GA to HbA1c ratio (GA/HbA1c) were observed in the Repa group without increasing hypoglycemia. When the Repa group was subdivided according to whether GA improved, the SU dose before switching to repaglinide was significantly smaller and the HOMA-beta was significantly higher in the GA improvement subgroup.
Results date posted
| 2020 | Year | 10 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 03 | Month | 01 | Day |
Baseline Characteristics
We enrolled 57 patients with type 2 diabetes from seven medical service units located in Hokkaido, Japan (Hokkaido University Hospital, Kuriyama Red Cross Hospital, Hokkaido Spinal Cord Injury Center, Manda Memorial Hospital, Oki Medical Clinic, Kurihara Clinic and Aoki Clinic). The participants were recruited to this trial between July 2016 and February 2017. All participants provided written informed consent before study enrollment. The inclusion criteria were as follows: patients with type 2 diabetes, aged 60 to 90 years, with HbA1c 7.0to 8.9%, body mass index below 25 kg/m2 and who had been taking SUs for more than 12 weeks before enrollment. In calculating the SU dose, we defined that 1 mg glimepiride was equivalent to 40 mg gliclazide and 1.25 mg glibenclamide. We excluded patients with serious liver dysfunction and those taking high doses of SU (more than 3 mg glimepiride).
Participant flow
This was a multicenter, prospective randomized, open label, parallel group comparison trial. Patients were randomly assigned to continue taking a SU once daily or to switch from SUs to three daily doses of 0.5 mg repaglinide (1.5 mg/day), according to HbA1c, body mass index and SU dose using computer software. All patients were encouraged to continue diet and exercise therapy during the study. Treatment was supervised at the appropriate medical care center for 12 weeks.
Adverse events
Hypoglycemia
Outcome measures
The primary outcome comprised the change in glycemic control, and among the secondary outcomes was the presence of hypoglycemia and drug compliance.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 30 | Day |
Last modified on
| 2020 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025968
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
