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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036788
Receipt No. R000041798
Scientific Title An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients
Date of disclosure of the study information 2019/05/18
Last modified on 2019/05/18

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Basic information
Public title An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients
Acronym An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients
Scientific Title An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients
Scientific Title:Acronym An investigation of therapeutic efficacy when switching from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin in type 2 diabetes patients
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study will investigate therapeutic efficacy when type 2 diabetes patients are switched from intensive insulin therapy to long-acting insulin plus either dulaglutide or empagliflozin.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Change in HbA1c from before switching treatment to 24 weeks after switching
Key secondary outcomes fasting blood glucose
2-h postprandial glucose
GA
insulin secretion capacity
pancreatic glucagon
flash glucose monitoring
Self-monitoring of blood glucose results
renal function
urinary albumin
L-FABP
Body weight
BMI
body composition
waist circumference
blood pressure
heart rate
lipids
UA
hepatic function
total protein
albumin
electrolytes
insulin dose
Evaluation of satisfaction with treatment
appetite
Adverse events

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dulaglutitde group:
switch from intensive insulin therapy to long-acting insulin plus dulaglutide(0.75mg/week). The primary endpoint is the change in HbA1c level from immediately before switching treatments to 24 weeks later.
Interventions/Control_2 Empagliflozin group:
switch from intensive insulin therapy to long-acting insulin plus empagliflozin(10mg/day). The primary endpoint is the change in HbA1c level from immediately before switching treatments to 24 weeks later.
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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients who have been undergoing treatment with intensive insulin therapy alone for or over12 weeks
2. Age or over 18 years and under 90 years
3. BMI under 45 kg/m2
4. Negative for anti-GAD antibodies
Key exclusion criteria 1. Patients with serious hepatic dysfunction
2. Patients with serious renal dysfunction
3. Patients taking steroids
4. Patients with cancer
5. Patients with severe infection or serious injury
6. Patients who are or could be pregnant
7. Patients with an allergy to the drug to be used or for whom it is contraindicated
8. Any other patients considered by the investigator or a subinvestigator to be unsuitable to participate in the study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Shinobu
Middle name
Last name Sato
Organization Chigasaki Municipal Hospital
Division name Division of Endocrinology & Metabolism
Zip code 2530042
Address 5-15-1, Honson, Chigasaki, Kanagawa
TEL 0467-52-1111
Email shinobu@medical.email.ne.jp

Public contact
Name of contact person
1st name Kohei
Middle name
Last name Ito
Organization Chigasaki Municipal Hospital
Division name Division of Endocrinology & Metabolism
Zip code 2530042
Address 5-15-1, Honson, Chigasaki, Kanagawa
TEL 0467-52-1111
Homepage URL
Email t186011a@yokohama-cu.ac.jp

Sponsor
Institute Chigasaki Municipal Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Chigasaki Municipal Hospital
Address 5-15-1, Honson, Chigasaki, Kanagawa
Tel 0467-52-1111
Email shinobu@medical.email.ne.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 茅ヶ崎市立病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 18 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
2018 Year 11 Month 29 Day
Date of IRB
2018 Year 11 Month 29 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2021 Year 11 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 18 Day
Last modified on
2019 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041798

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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