UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009525 |
|---|---|
| Receipt number | R000011186 |
| Scientific Title | Clinical study on glycemic excursion improvements with a DPP-4 inhibitor and a glinide in patients with type 2 diabetic mellitus - a comparative efficacy analysis using continuous glucose monitoring (CGM) - |
| Date of disclosure of the study information | 2012/12/20 |
| Last modified on | 2013/09/27 09:26:54 |
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Basic information
Public title
Clinical study on glycemic excursion improvements with a DPP-4 inhibitor and a glinide in patients with type 2 diabetic mellitus
- a comparative efficacy analysis using continuous glucose monitoring (CGM) -
Acronym
Clinical study on glycemic excursion using CGM in patients with type 2 diabetic mellitus
Scientific Title
Clinical study on glycemic excursion improvements with a DPP-4 inhibitor and a glinide in patients with type 2 diabetic mellitus
- a comparative efficacy analysis using continuous glucose monitoring (CGM) -
Scientific Title:Acronym
Clinical study on glycemic excursion using CGM in patients with type 2 diabetic mellitus
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Either sitagliptin or mitiglinide will be randomly allocated and used concomitantly, in patients with type 2 diabetes mellitus being treated with acarbose, then glycemic excursion improvement with these drugs will be comparatively investigated using CGM with open-label methods. Thereafter, the drugs will be switched to a fixed mitiglinide / voglibose combination and comparative investigated, to evaluate the clinical characteristics of a next combination.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary efficacy endpoints are the CGM glycemic change parameters: distribution of blood glucose measures, mean blood glucose levels, standard deviations (SD), number of times / AUC deviations from a target blood glucose range, and the mean amplitude of glycemic excursions (MACE) in the treatment periods.
Secondary endpoints are: glycemic control parameters, oxidative stress markers, and inflammation markers in the treatment periods.
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
Either sitagliptin or mitiglinide will be randomly allocated in patients with type 2 diabetes mellitus being treated with acarbose.
Interventions/Control_2
After the add-on therapy of sitagliptin / mitiglinide with acarbose, drugs will be switched to a fixed mitiglinide / voglibose combination to be administered.
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 using acarbose as an antidiabetic medication for 8 weeks or more, in addition to diet therapies and exercise regimens for diabetes
2)Patients who have HbA1c levels from 6.2% to 7.9% (NGSP)
3)Adult patients (≥20 years) at the time their consent is obtained
4)Patients to whom the significance, objectives and methods of this study have been explained, and from whom consent can be willingly obtained
Key exclusion criteria
1)Patients to whom [Contraindications] in labeling for the experimental drugs (sitagliptin and mitiglinide formulations or sitagliptin / mitiglinide combinations) apply
2)Any others who the principal investigator deems unsuitable as subjects, in consideration of any [Special caution needed] in labeling for the experimental drugs
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Osonoi |
Organization
Naka Kinen Clinic
Division name
Director
Zip code
Address
745-5, Nakadai, Naka-city, Ibaragi-Prefecture
TEL
029-353-2800
erika-yamagishi@npo-acro.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Erika Yamagishi |
Organization
dvanced Clinical Research Organization
Division name
dvanced Clinical Research Organization
Zip code
Address
4F Hoei Fuchu Building,2-10-3 Kotobukicho,Fuchu-shi Tokyo
TEL
029-353-2800
Homepage URL
erika-yamagishi@npo-acro.jp
Sponsor or person
Institute
Naka Kinen Clinic
Institute
Department
Personal name
Funding Source
Organization
Advanced Clinical Research Organization
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 20 | 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 | 11 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 20 | 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
| 2012 | Year | 12 | Month | 11 | Day |
Last modified on
| 2013 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011186
