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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024427
Receipt No. R000028110
Scientific Title Comparison of dapagliflozin, sitagliptin, and metformin as initial drug therapy in patients with type 2 diabetes
Date of disclosure of the study information 2016/10/16
Last modified on 2016/10/16

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Basic information
Public title Comparison of dapagliflozin, sitagliptin, and metformin as initial drug therapy in patients with type 2 diabetes
Acronym Comparison of dapagliflozin, sitagliptin, and metformin as initial drug therapy in patients with type 2 diabetes
Scientific Title Comparison of dapagliflozin, sitagliptin, and metformin as initial drug therapy in patients with type 2 diabetes
Scientific Title:Acronym Comparison of dapagliflozin, sitagliptin, and metformin as initial drug therapy in patients with type 2 diabetes
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to examine the efficacy and safety of dapagliflozin, sitagliptin, and metformin as initial drug therapy in patients with type 2 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change from baseline in fasting and postprandial blood glucose at week 12 by meal tolerance test
Key secondary outcomes Change from baseline in HbA1c, body weight, fasting and postprandial serum insulin, proinsulin/insulin ratio, serum adiponectin at week 12

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dapagliflozin 5 mg per day for 12 weeks
Interventions/Control_2 Sitagliptin 50 mg per day for 12 weeks
Interventions/Control_3 Metformin 1000 mg per day for 12 weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Type 2 diabetic patients
2. HbA1c higher than 6.5% and lower than 11.0%
3. BMI higher than 20 and lower than 40 kg/m2
4. Patients who have been treated diet and exercise therapy alone, or patients who have never received drug therapy at baseline.
5. Patients who are able to provide written informed consent.
Key exclusion criteria 1. Patients who have history or current serious diabetic complication.
2. Patients that insulin dependence is suspected.
3. Patients who have history or current cardiac failure (New York Heart Association Class III or IV), myocardial infarction or cerebrovascular disorder.
4. Patients whose eGFR lower than 45 mL/min/1.73m2, serum creatinine higher than 1.5 mg/dL.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Ito
Organization Ogawa Red Cross Hospital
Division name Department of Internal Medicine
Zip code
Address 1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan
TEL 0493-72-2333
Email dito@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Ito
Organization Ogawa Red Cross Hospital
Division name Department of Internal Medicine
Zip code
Address 1525, Ogawa, Ogawa, Hiki-gun, Saitama, Japan
TEL 0493-72-2333
Homepage URL
Email dito@saitama-med.ac.jp

Sponsor
Institute Ogawa Red Cross Hospital
Institute
Department

Funding Source
Organization Ogawa Red Cross Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Saitama Medical University
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
2016 Year 10 Month 16 Day

Related information
URL releasing protocol
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 Enrolling by invitation
Date of protocol fixation
2014 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 17 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
2016 Year 10 Month 16 Day
Last modified on
2016 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028110

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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