UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024817 |
|---|---|
| Receipt number | R000028565 |
| Scientific Title | Glucose excursions in patients with type 2 diabetes treated with mitiglinide/voglibose versus glimepiride: A randomized cross-over trial |
| Date of disclosure of the study information | 2016/11/14 |
| Last modified on | 2017/01/25 16:33:16 |
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Basic information
Public title
Glucose excursions in patients with type 2 diabetes treated with mitiglinide/voglibose versus glimepiride: A randomized cross-over trial
Acronym
Glucose excursions with mitiglinide/voglibose versus glimepiride
Scientific Title
Glucose excursions in patients with type 2 diabetes treated with mitiglinide/voglibose versus glimepiride: A randomized cross-over trial
Scientific Title:Acronym
Glucose excursions with mitiglinide/voglibose versus glimepiride
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate glucose excursions and the frequency of hypoglycemia in patients with type 2 diabetes treated with mitiglinide/voglibose versus glimepiride
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Glycemic excursions and the frequency of hypoglycemic evaluated using CGM on the last day of both periods
Key secondary outcomes
Metabolic profile changes during MTT
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After receiving vildagliptin 100 mg, patients were randomized to have add-on therapy as either the fixed-dose combination drug mitiglinide/voglibose 10 mg/0.2 mg three times daily for a few days followed by glimepiride 1 mg once daily for several subsequent days
Interventions/Control_2
or vice versa
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with type 2 diabetes who were taking DPP-4 inhibitors and were admitted to the general hospital for glycemic control
Key exclusion criteria
patients with insulin dependent diabetes; known allergies to mitiglinide, voglibose, or glimepiride; hepatic dysfunction; renal dysfunction; use of corticosteroids; existing pregnancy; alcoholism; a history of severe hypoglycemic episodes; a history of diabetic ketoacidosis; diabetic retinopathy with a high risk of hemorrhage
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanta Fujimoto |
Organization
Kobe City Medical Center General Hospital
Division name
Internal Medicine of Diabetes and Endocrinology
Zip code
Address
2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe, Japan
TEL
075-302-4321
kantachi@kcho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanta Fujimoto |
Organization
Kobe City Medical Center General Hospital
Division name
Internal Medicine of Diabetes and Endocrinology
Zip code
Address
2-1-1 Minatojimaminamimachi, Chuo-ku, Kobe, Japan
TEL
075-302-4321
Homepage URL
kantachi@kcho.jp
Sponsor or person
Institute
Kitano 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
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
北野病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 14 | 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
The mean glucose levels in the mitiglinide/voglibose and glimepiride groups were almost equal. the mitiglinide/voglibose group showed a significantly lower SD of glucose, MAGE, M-value, CONGA-1 value, and AUC >10 mmol/L than the glimepiride group. Hypoglycemia was not observed with mitiglinide/voglibose, whereas it was observed 0.35 times per day with glimepiride.
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 | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 13 | Day |
Last modified on
| 2017 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028565
