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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021479
Receipt No. 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

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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
Email 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
Email nsatoh@kuhp.kyoto-u.ac.jp

Sponsor
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024346

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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