UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019033 |
|---|---|
| Receipt number | R000021905 |
| Scientific Title | Comparison of glycemic variations in Japanese patients with type 2 diabetes, between metformin high dose group and combination of metformin and sitagliptin or linagliptin group as assessed by continuous glucose monitoring (CGM) |
| Date of disclosure of the study information | 2015/09/17 |
| Last modified on | 2018/09/18 14:32:27 |
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Basic information
Public title
Comparison of glycemic variations in Japanese patients with type 2 diabetes, between metformin high dose group and combination of metformin and sitagliptin or linagliptin group as assessed by continuous glucose monitoring (CGM)
Acronym
Comparison of glycemic variations in T2D, between metformin highdose group and combination of metformin and sitagliptin or linagliptin group as assessed by CGM
Scientific Title
Comparison of glycemic variations in Japanese patients with type 2 diabetes, between metformin high dose group and combination of metformin and sitagliptin or linagliptin group as assessed by continuous glucose monitoring (CGM)
Scientific Title:Acronym
Comparison of glycemic variations in T2D, between metformin highdose group and combination of metformin and sitagliptin or linagliptin group as assessed by CGM
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 the glycemic variability by using CGM in patients with type 2 diabetes who receinig the metformin(1,500mg) versus receing the metformin(750mg) and sitagliptin(50mg) or linagliptin(5mg).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glucose variability in CGM
1)Mean glucose levels
2)Standard deviations of glucose (SD)
3)MAGE
4)Time in hypoglycemia
5)Time in hyperglycemia
6)Area under the curve(AUC)
7)Magnitude of increase in glucose levels
8)The time to peak glucose levels from baseline after each meal
Key secondary outcomes
Pre-meal plasma glucose, 1 hour post prandial glucose, 2 hour post prandial glucose
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
After more than 4 weeks of treatment at metformin (1500mg), it change to sitagliptin (50mg) or linagliptin (5mg) + metformin (750mg).
Interventions/Control_2
After more than 4 weeks of treatment at sitagliptin (50mg) or linagliptin (5mg) + metformin (750mg), it change to metformin (1500mg).
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
1)Type 2 diabetes
2)Patients who are administrated dose of metformin (500-1,000 mg/day) for 2 weeks or more
3)HbA1c >= 7.0% and <10.0%
4) Patients who were on the diet therapy
5)Patients who give written informed consent to participate in this study on a voluntary basis after receiving and understanding a sufficient explanation of the study
Key exclusion criteria
1)Patients with type 1 diabetes
2)Patients with insulin therapy
3)Patients who take oral hypoglycemic agent other than metformin
4)Patients with severe acidosis or diabetic coma
5)Patients with infections, before and after surgery,and severe trauma
6)Patiens with severe liver disease
7)Patients with severe renal disease with a serum creatinine (Cr) level (mg/dL) >1.5
8)Patients with shock, heart disease (heart failure, myocardial infarction, pulmonary embolism), severe lung failure
9)Patients with malnutrition, starvation, debilitating condition, pituitary dysfunction, adrenal insufficiency
10)Patients have history of lactic acidosis
11)Heavy drinkers
12)Patients with dehydration, gastrointestinal disorders (diarrhea, vomiting,etc)
13)Cancer patients
14)Patients for the biguanide drug with a history of allergy, or with a history of other drug allergy
15)Potential pregnant patients or patient with who are breast feeding
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Takahashi |
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
hiro3431_6117@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Takahashi |
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
Homepage URL
hiro3431_6117@yahoo.co.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Diabetes Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2015 | Year | 09 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 03 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 16 | Day |
Last modified on
| 2018 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021905
