UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018871 |
|---|---|
| Receipt number | 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 | 2020/09/09 10:17:06 |
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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 | 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
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
masuda@cardiology.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020114
