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 |
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
Effect of dapagliflozin on FGF21.
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
Effect of dapagliflozin on FGF21.
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
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
Efficacy
Confirmatory
Explanatory
Phase IV
Serum FGF21 level (At 0, 12 and 24 weeks after administration)
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)
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
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.)
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.].)
20 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
80
1st name | Noriko |
Middle name | |
Last name | Satoh-Asahara |
National Hospital Organization Kyoto Medical Center
Division of Diabetic Research,Clinical Research Institute
612-8555
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555 Japan
075-645-9161
nsatoh@kuhp.kyoto-u.ac.jp
1st name | Noriko |
Middle name | |
Last name | Satoh-Asahara |
National Hospital Organization Kyoto Medical Center
Division of Diabetic Research,Clinical Research Institute
612-8555
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555 Japan
075-645-9161
nsatoh@kuhp.kyoto-u.ac.jp
National Hospital Organization Kyoto Medical Center
Astrazeneca Pharmaceutical company,
Ono Pharmaceutical Co.Ltd
Profit organization
Clinical Research Institute, National Hospital Organization, Kyoto Medical Center
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, 612-8555, Japan
075-645-9161
ashimats@kyotolan.hosp.go.jp
NO
国立病院機構 京都医療センター(京都府)
2016 | Year | 04 | Month | 01 | Day |
https://onlinelibrary.wiley.com/doi/full/10.1111/jdi.13179
Published
https://onlinelibrary.wiley.com/doi/full/10.1111/jdi.13179
60
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.
2020 | Year | 06 | Month | 19 | Day |
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]).
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.
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.
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.
Completed
2016 | Year | 02 | Month | 15 | Day |
2016 | Year | 01 | Month | 18 | Day |
2016 | Year | 04 | Month | 01 | Day |
2018 | Year | 06 | Month | 30 | Day |
2016 | Year | 03 | Month | 15 | Day |
2020 | Year | 06 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024346