UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001891 |
|---|---|
| Receipt number | R000002278 |
| Scientific Title | Comparative Efficacy of Pioglitazone and Metformin in Glucose Variability in Type 2 Diabetes |
| Date of disclosure of the study information | 2009/04/15 |
| Last modified on | 2012/04/17 14:33:55 |
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Basic information
Public title
Comparative Efficacy of Pioglitazone and Metformin in Glucose Variability in Type 2 Diabetes
Acronym
Comparative Efficacy of Pioglitazone and Metformin in Glucose Variability in Type 2 Diabetes
Scientific Title
Comparative Efficacy of Pioglitazone and Metformin in Glucose Variability in Type 2 Diabetes
Scientific Title:Acronym
Comparative Efficacy of Pioglitazone and Metformin in Glucose Variability in Type 2 Diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare glucose variability in patients given pioglitazone or metformin by using continuous glucose monitoring (CGM).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glucose variability in CGM (area under the glucose curve from pre-meal baseline to baseline, pattern of glucose curve, magnitude of increase in glucose levels and the time to peak glucose levels from baseline after each meal)
Key secondary outcomes
Pre-meal plasma glucose, 2 hour post prandial glucose, side effect, body weight change
Base
Study type
Interventional
Study design
Basic design
Parallel
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
pioglitazone
Interventions/Control_2
metformin
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
Type 2 diabetic patients on no other antidiabetic medications (6.0=<HbA1c<10.0%, BMI>=25kg/m2)
Key exclusion criteria
Patients with type 1 diabetes, patients with severe liver disease, patients with severe renal disease, patients with severe heart disease, patients with history of myocardial infarction within 6 months, patients with severe pancreatic disease, cancer patients, patients with severe diabetic neuropathy, patients with severe diabetic retinopathy, patients with history of lactic acidosis, heavy drinkers, pregnant patients
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Aya Morimoto |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
3-25-8, Nishishinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aya Morimoto |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
3-19-18, Nishisinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine
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
| 2009 | Year | 04 | Month | 15 | 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
| 2009 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 15 | Day |
Last modified on
| 2012 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002278
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
