UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011243 |
|---|---|
| Receipt number | R000013178 |
| Scientific Title | Comparison of the hypoglycemic effect of sitagliptin versus the combination of mitiglinide and voglibose in drug-naïve Japanese patients with type 2 diabetes |
| Date of disclosure of the study information | 2013/07/22 |
| Last modified on | 2013/07/22 14:34:18 |
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Basic information
Public title
Comparison of the hypoglycemic effect of sitagliptin versus the combination of mitiglinide and voglibose in drug-naïve Japanese patients with type 2 diabetes
Acronym
Comparison of the hypoglycemic effect of sitagliptin versus the combination of mitiglinide and voglibose
Scientific Title
Comparison of the hypoglycemic effect of sitagliptin versus the combination of mitiglinide and voglibose in drug-naïve Japanese patients with type 2 diabetes
Scientific Title:Acronym
Comparison of the hypoglycemic effect of sitagliptin versus the combination of mitiglinide and voglibose
Region
| Japan |
Condition
Condition
drug-naïve type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the present study, we compared the effect of sitagliptin (a DPP-4I) monotherapy with that of the combination of mitiglinide and voglibose (M+V) on postprandial glucose excursion in a randomized cross-over study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Levels of HbA1c, glycoalbumin (GA), and 1,5-anhydroglucitol (1,5-AG) were measured at base line and 8weeks.
Key secondary outcomes
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
They were randomized to receive the combination of mitiglinide and voglibose Sitagliptin was administered at a dose of 50 mg once daily after breakfast for 8 weeks (S-first group), while the combination of mitiglinide (10 mg) and voglibose (0.2 mg) was administered three times daily just before each meal for 8 weeks (M+V-first group).
Interventions/Control_2
Sitagliptin 50mg/day
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
Inclusion criteria were stable, but slightly inadequate, glycemic control (6.2HbA1c7.5%, and variation of HbA1c by <0.5% within 3 months before recruitment) without the use of insulin or oral antidiabetic drugs.
Key exclusion criteria
The exclusion criteria were pregnancy, severe illness, anemia, renal failure (serum creatinine>2.0 mg/dL) and/or overt proteinuria, chronic liver disease, thyroid disease, and malignancy.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Ota |
Organization
St. Marianna University School of Medicine
Division name
Department of Internal Medicine, Division of Metabolism and Endocrinology
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
St. Marianna University School of Medicine
Division name
Department of Internal Medicine, Division of Metabolism and Endocrinology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
St. Marianna University School of Medicine, Department of Internal Medicine, Division of Metabolism and Endocrinology
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine, Department of Internal Medicine, Division of Metabolism and Endocrinology
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 22 | 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
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 02 | 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 | 07 | Month | 22 | Day |
Last modified on
| 2013 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013178
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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