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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018871
Receipt No. R000020114
Scientific Title Effects of Dapagliflozin on Hyperlipidemia, Glycemic Control and Insulin Resistance in Type 2 Diabetic Patients (DAPHNIS study)
Date of disclosure of the study information 2015/09/01
Last modified on 2018/08/03

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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
Middle name
Last name Shizuya Yamashita, MD, PhD, FAHA, FJCC
Organization Osaka University Graduate School of Medicine
Division name Department of Community Medicine
Zip code
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
Middle name
Last name Daisaku Masuda, MD, PhD
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
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 Graduate School of Medicine
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
Address
Tel
Email

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
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 07 Month 09 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 15 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 09 Month 01 Day
Last modified on
2018 Year 08 Month 03 Day


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

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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