UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Dapagliflozin on Hyperlipidemia, Glycemic Control and Insulin Resistance in Type 2 Diabetic Patients (DAPHNIS study)
Acronym	Effects of Dapagliflozin on Hyperlipidemia, Glycemic Control and Insulin Resistance in Type 2 Diabetic Patients (DAPHNIS study)
Scientific Title	Effects of Dapagliflozin on Hyperlipidemia, Glycemic Control and Insulin Resistance in Type 2 Diabetic Patients (DAPHNIS study)
Scientific Title:Acronym	Effects of Dapagliflozin on Hyperlipidemia, Glycemic Control and Insulin Resistance in Type 2 Diabetic Patients (DAPHNIS study)
Region	Japan

Condition
Condition	type 2 diabetes mellitus
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we will investigate whether dapagliflozin (FORXIGA) might improve lipoprotein metabolism as well as hyperglycemia in Japanese patients with type II diabetes mellitus by examining before and 4 and 8 weeks after the administration of dapagliflozin.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	To examine changes of fasting lipoprotein profile by the administration of dapagliflozin; Concentrations of apoB-48 and RemL-C by examining before and 4 and 8 weeks after the administration of dapagliflozin.
Key secondary outcomes	Following points will be examined before and 4 and 8 weeks after the administration of dapagliflozin. 1. To examine changes of fasting glucose and HbA1c (NGSP) level by the administration of dapagliflozin 2. To examine changes of fasting lipid profile by the administration of dapagliflozin; Concentrations of TG, TC, HDL-C and LDL-C 3. To examine changes of fractions of free fatty acids, protein mass of LPL, and lipoprotein profile assessed by the HPLC by the administration of dapagliflozin 4. To examine changes of biomarkers for renal and hepatic function by the administration of dapagliflozin 5. To examine the frequency of adverse effects by the administration of dapagliflozin

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Dapagliflozin is orally administered for 8 weeks in the dose of 5mg per day if there is no serious event included in termination criteria. If the effect for improving diabetes is insufficient, it is allowed to raise its dose up to 10mg/day.
Interventions/Control_2
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Male or female subjects with type 2 diabetes mellitus of from 20 to 65 years of age. 2. Patients who have not achieve the clinical target of the glycemic control (less than 7.0% in HbA1c). 3. Patients who received the diet therapy, the exercise therapy or the following anti-diabetic drugs in addition to the diet and/or exercise therapy (up to two drugs) with dosage stable for 8 weeks prior to entry. a. Sulfonylurea (Glymepiride 2mg/day or less, Glibenclamide 1.25mg/day or less, Gliclazide 40mg/day or less) b. Thiazolidine (Actos) c. Biganide (Metformin, Buformin) d. alpha-glucosidase inhibitor (Voglibose, Miglitol, Acarbose) e. DPP4 inhibitors (Sitagliptin, Linagliptin, Anagliptin, Teneligliptin, Alogliptin, Saxagliptin) 4. Informed consent to participate in the study prior to any study procedures.
Key exclusion criteria	1. Type 1 diabetes mellitus 2. Moderate or severe renal dysfunction (eGFR<45 ml/min/1.73m2 or hemodialysis) 3. Severe hepatic insufficiency (AST and/or ALT >3x upper limit of normal) 4. Adrenal insufficiency or pituitary gland dysfunction 5. Malnourishment, starvation, irregular dietary intake, poor dietary intake, debilitating condition or a severe muscle movement 6. Volume depleted patients; concomitant medication such as loop diuretics. 7. Excessive alcohol intake (>60g daily) 8. SGLT2 inhibitors such as dapagliflozin are already administered 9. Contraindication with dapagliflozin 10. Start a new medication of statins, fibratesm ezetimibe or probucol within a month 11. Females who are likely to be pregnant, during pregnancy or lactating 12. Participants in other clinical trials 13. Inability to communicate and comply with all study requirements.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Shizuya Middle name Last name Yamashita
Organization	Osaka University Graduate School of Medicine
Division name	Department of Community Medicine
Zip code	565-0871
Address	Yamadaoka 2-2, Suita, Osaka, 565-0871 JAPAN
TEL	06-6879-3633
Email	shizu@cardiology.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Daisaku Middle name Last name Masuda
Organization	Osaka University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code	565-0871
Address	Yamadaoka 2-2, Suita, Osaka, 565-0871 JAPAN
TEL	06-6879-3633
Homepage URL	http://www.cardiology.med.osaka-u.ac.jp/?post_type=clinical
Email	masuda@cardiology.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	non-political organization (The Supporting Center for Clinical Research and Education, SCCRE) from Astrazeneca Corp and Ono Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Hospital Institutional Review Board
Address	Yamadaoka 2-2, Suita, Osaka, 565-0871 JAPAN
Tel	06-6210-8296
Email	rinri@hp-crc.osaka-u.ac.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

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 01 Day

Related information
URL releasing protocol	http://www.cardiology.med.osaka-u.ac.jp/?post_type=clinical
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	31
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	2015 Year 07 Month 09 Day
Date of IRB	2015 Year 07 Month 09 Day
Anticipated trial start date	2015 Year 08 Month 15 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 03 Month 28 Day

Other
Other related information

Management information
Registered date	2015 Year 09 Month 01 Day
Last modified on	2020 Year 09 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020114