UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021479 |
|---|---|
| Receipt number | R000024346 |
| Scientific Title | Effect of dapagliflozin, the sodium-glucose-cotransporter-2 (SGLT2) inhibitor, on fibroblast growth factor 21 (FGF21), a novel hepatokine and myokine, in Japanese patients of type 2 diabetes |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2020/06/19 18:08:58 |
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Basic information
Public title
Effect of dapagliflozin, the sodium-glucose-cotransporter-2 (SGLT2) inhibitor, on fibroblast growth factor 21 (FGF21), a novel hepatokine and myokine, in Japanese patients of type 2 diabetes
Acronym
Effect of dapagliflozin on FGF21.
Scientific Title
Effect of dapagliflozin, the sodium-glucose-cotransporter-2 (SGLT2) inhibitor, on fibroblast growth factor 21 (FGF21), a novel hepatokine and myokine, in Japanese patients of type 2 diabetes
Scientific Title:Acronym
Effect of dapagliflozin on FGF21.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of dapagliflozin on the serum FGF21 levels in type 2 diabetic patients. To evaluate the effect of dapagliflozin on body composition (total body fat and lean body mass / skeletal muscle mass / ectopic fat deposition), as well as glucose metabolism and insulin sensitivity in type 2 diabetic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Serum FGF21 level (At 0, 12 and 24 weeks after administration)
Key secondary outcomes
Fasting plasma glucose, body weight, waist circumference, blood pressures, visceral fat mass, subcutaneous fat mass, CAVI, leptin, adiponectin, hs-CRP, muscle thickness of six sites of the body using B-mode ultrasound, skeletal muscle mass, % fat, total body water weight ratio, lean body mass, basal metabolic rate, and serum other miokines (myostatin, irisin, IL-6)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Interventions group: Conventional treatment + Dapagliflozin [5 mg/day] (On or after week 12, if HbA1c was >7.5% and there were no safety concerns, dapagliflozin would be up-titrated to 10 mg/day.)
Interventions/Control_2
Control group: Conventional treatment (On or after week 12, if HbA1c was >7.5% and there were no safety concerns, intensification of treatment would be undertaken [up-titration of the medicine, administration of another medicine etc.].)
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. Outpatient
2. BMI: more than 22 kg/m2
3. HbA1c(NGSP): 6.5% to less than 9.0%
4. Subject have a diet and exercise therapy
5. Subject have SU/MET/alpha-GI/DPP-IV inhibitor or their combinations
Key exclusion criteria
1.Subjects with secondary obesity associated with endocrine disorders
2.Type 1 diabetes mellitus
3.Subjects with severe ketosis, diabetic coma or precoma
4.Subjects with severe infection, before and after surgery or severe injury
5.Subjects with severe hepatic dysfunction
6.Subjects with moderate or more of renal dysfunction (serum creatinine >= 1.5mg/dl[male], 1.3mg/dl[female]).
7.The subjects within the past 6 months, developed stroke, myocardial infarction, or other serious vascular complications requiring hospitalization
8.Subjects with dehydration, diarrhea, vomiting or gastrointestinal injury
9.Subjects in SGLT-2 inhibitors, insulin formulation, GLP-1 receptor agonist prescription
10.Subjects in TZD, fibrate prescription
11.Subjects in pregnant women, lactating women, the potential or planned are pregnant
12.Subjects with a history of hypersensitivity to SGLT-2 inhibitor
13.Subjects who have been determined to be unsuitable for the attending physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Satoh-Asahara |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Diabetic Research,Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555 Japan
TEL
075-645-9161
nsatoh@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Satoh-Asahara |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Diabetic Research,Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555 Japan
TEL
075-645-9161
Homepage URL
nsatoh@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Astrazeneca Pharmaceutical company,
Ono Pharmaceutical Co.Ltd
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
Clinical Research Institute, National Hospital Organization, Kyoto Medical Center
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, 612-8555, Japan
Tel
075-645-9161
ashimats@kyotolan.hosp.go.jp
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
国立病院機構 京都医療センター(京都府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1111/jdi.13179
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/jdi.13179
Number of participants that the trial has enrolled
60
Results
Bodyweight decreased in the dapagliflozin group, but the changes in SMM were not significant between the groups, thereby elevating the ratio of SMM-to-bodyweight in the dapagliflozin group. Myostatin levels were significantly decreased, and irisin levels showed a nearly significant reduction in the dapagliflozin group compared with the control group, whereas FGF21 levels did not change significantly from baseline to the end of the intervention in both groups.
Results date posted
| 2020 | Year | 06 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The characteristics at baseline were balanced between the dapagliflozin (sex: 11/16, age:58.4[13.0], HbA1c:7.5[0.8]) and control groups(sex: 14/13, age:60.7[11.9], HbA1c:7.4[0.9]).
Participant flow
A total of 60 patients were screened, and 54 were randomly assigned to recieve either dapagliflozin in addition to conventional treatment (dapagliflozin group or conventional treatment witout dapagliflozion (control group; n=27 each). In the dapagliflozion arm, 26 patients completed the study, with one dropping out because of study medication-related comlications. In the control arm, 24 patients comleted the study, with one withdrawing and two having a scheduling conflict.
Adverse events
Five adverse events were reported by two patients after randomization. No patient had a serious adverse event requiring hospitalization. One patient in the dapagliflozin group developed dehydration within 1 day of initiation of the drug. The drug was discontinued, and the symptoms improved. One patient in the control group developed hunger, dizziness and cramps within 1 day of initiation of the drug, and finger tumor deterioration within 20 weeks of initiation of the drug.
Outcome measures
Bodyweight decreased in the dapagliflozin group, but the changes in SMM were not significant between the groups, thereby elevating the ratio of SMM-to-bodyweight in the dapagliflozin group. Myostatin levels were significantly decreased, and irisin levels showed a nearly significant reduction in the dapagliflozin group compared with the control group, whereas FGF21 levels did not change significantly from baseline to the end of the intervention in both groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 15 | Day |
Last modified on
| 2020 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024346
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