UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018364 |
|---|---|
| Receipt number | R000021261 |
| Scientific Title | Randomized comparative study of ipragliflozin combination therapy and sitagliptin combination therapy in patients with type 2 diabetes administrating metformin |
| Date of disclosure of the study information | 2015/07/21 |
| Last modified on | 2020/02/14 13:34:36 |
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Basic information
Public title
Randomized comparative study of ipragliflozin combination therapy and sitagliptin combination therapy in patients with type 2 diabetes administrating metformin
Acronym
Randomized comparative study of ipragliflozin combination therapy and sitagliptin combination therapy in patients with type 2 diabetes administrating metformin
Scientific Title
Randomized comparative study of ipragliflozin combination therapy and sitagliptin combination therapy in patients with type 2 diabetes administrating metformin
Scientific Title:Acronym
Randomized comparative study of ipragliflozin combination therapy and sitagliptin combination therapy in patients with type 2 diabetes administrating metformin
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the proper choice of hypoglycemic agents in combination with metformin in Japanese patients with type 2 diabetes by comparing the efficacy of ipragliflozin and sitagliptin with special reference to patients' lifestyle.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of percentage of patients who achieve the following items 52 weeks after randomization
1) Decreased HbA1c values by 0.5% or more
2) No increase of body weight
Key secondary outcomes
1) Comparison of percentage of patients achieved following items after 12, 24 and 36 weeks from randomization
1. Decrease of >= 0.5% HbA1c
2. No increase of body weight
2) Comparison of change or percent change of following items after 4, 12, 24, 36 and 52 weeks from randomization
1. HbA1c, fasting plasma glucose, blood insulin/serum C-pepitide (Fasting)
2. Body weight, BMI, waist circumference
3. Serum lipid (Fasting TG, TC, LDL-C, HDL-C)
4. SBP/DBP (Casual blood pressure)
5. Urinary albumin, transferrin, NAG, electrolyte (Na, K, Cl) (Spot urine)
6. Target level achievement rate (HbA1c, blood pressure, lipid etc.)
7. JJ risk engine score
Above data are summarized and analysed stratified by patient characteristics such as occupation, employment situation and lifestyle (Diet and exercise).
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
Sitagliptin 50 mg
Orally administration once a day
Interventions/Control_2
Ipragliflozin 50 mg
Orally administration once a day, pre or post breakfast
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 before initiation of metformin monotherapy ]
1) Type 2 diabetes
2) Aged from 20 to 80 years at providing consent
3) With poorly glycemic controlled, nevertheless undergo diet and exercise therapy or administrated oral hypoglycemic agents
4) HbA1c >= 6.5% and <10.0%
5) Provided written informed consent
[Inclusion criteria at randomization]
6) Patients who are only administrated identical dose of metformin (>= 500 mg/day) for 8 weeks or more
7) HbA1c >= 6.5% and <10.0%
Key exclusion criteria
1) Type 1 diabetes
2) With severe ketosis, diabetic coma, or precoma within 6 months from the day of providing consent
3) With severe infection, pre or post surgery, and serious trauma
4) With moderate or severe renal dysfunction (Serum Creatinine male: >= 1.3 mg/dL, female: >= 1.2 mg/dL)
5) With severe hepatic disorder
6) Has history of stroke, myocardial infarction, or other serious cardiovascular complications requiring hospitalization
7) Has history of lactic acidosis
8) Patients who drink excessive alcohol
9) Has urinary tract infection, genital infection and dehydration at providing consent
10) Administrated insulin, GLP-1 receptor agonist within 1 year
11) Is pregnant, nursing, possibly pregnant and planned to become pregnant
12) Has history of hypersensitivity to SGLT-2 inhibitors, DDP-4 inhibitors and BG
13) Considered as inadequate by the investigator
Target sample size
166
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohito Sone |
Organization
Niigata University Fuculty of Medicine
Division name
Department of Hematology,Endocrinology and Metabolism
Zip code
Address
1-754, Asahimachi-Dori, Chuo-ku, Niigata
TEL
025-368-9026
sone@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Sano |
Organization
Niigata University Medical and Dental Sciences
Division name
Administration Division
Zip code
Address
1-754, Asahimachi-Dori, Chuo-ku, Niigata
TEL
025-368-9026
Homepage URL
sanonao@adm.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Fuculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
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 | 07 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 17 | 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
| 2015 | Year | 07 | Month | 21 | Day |
Last modified on
| 2020 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021261
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