UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020037 |
|---|---|
| Receipt number | R000022941 |
| Scientific Title | Comparison of the efficacy and safety of dulaglutide in combination with insulin compared with insulin alone in daibetes patients who are receiving high dose glucocorticoids therapy: a randomized,open-label trial |
| Date of disclosure of the study information | 2015/12/02 |
| Last modified on | 2017/01/25 13:55:23 |
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Basic information
Public title
Comparison of the efficacy and safety of dulaglutide in combination with insulin compared with insulin alone in daibetes patients who are receiving high dose glucocorticoids therapy: a randomized,open-label trial
Acronym
Comparison of the efficacy and safety of dulaglutide in combination with insulin compared with insulin alone in daibetes patients who are receiving high dose glucocorticoids therapy: a randomized,open-label trial
Scientific Title
Comparison of the efficacy and safety of dulaglutide in combination with insulin compared with insulin alone in daibetes patients who are receiving high dose glucocorticoids therapy: a randomized,open-label trial
Scientific Title:Acronym
Comparison of the efficacy and safety of dulaglutide in combination with insulin compared with insulin alone in daibetes patients who are receiving high dose glucocorticoids therapy: a randomized,open-label trial
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of combination of dulaglutide and insulin in patients with diabetes who are receiving high dose glucocorticoids therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of HbA1c at the 24th week
Key secondary outcomes
Change of date shown below at the 12th and 24th week.
HbA1c(at the 12th week),GA,body weight,blood pressure,total cholesterol,triglyceride,LDL-cholesterol,HDL-cholesterol,fasting plasma glucose,c-peptide(at the 24th week),urine albumin(mg/gCr)(at the 24th week),KL-6
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combination therapy with dulaglutide and insulin group:Injection of 0.75mg dulaglutide once a week, before breakfast
Multiple injection of rapid acting insulin and NPH insulin.Adjust the insulin dose according to the algorithm to keep blood glucose of before each meal 90-130mg/dl,2 hours after meals less than 180mg/dl.Obsevation period:24 weeks after the administration.
Interventions/Control_2
Insulin monotherapy group:
Multiple injection of rapid acting insulin and NPH insulin.Adjust the insulin dose according to the algorithm to keep blood glucose of before each meal 90-130mg/dl,2 hours after meals less than 180 mg/dl.Obsevation period:24 weeks after the administration.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1Patients treated with insulin therapy
2Patients expected to have high-dose steroid(10mg or more of prednisolone each day) during the next 6 months
Key exclusion criteria
1Patients less than 20 years old or 80 years of age or more
2Patients who are pregnant, breastfeeding or may become pregnant
3Type 1 diabetes mellitus patients
4Insulin-dependent diabetes mellitus patients
5Patients with severe infection or severe trauma
6Patients with severe hepatic disease
7Patients with severe renal disease
8Patients with hypopituitarism and/or adrenal insufficiency
9Patients with severe gastroenteric disturbance as exemplified by severe gastro-paresis.
10Patients with a history of pancreatitis
11Patients with malnutrition
12Patients taking DPP4-I,SGLT2I,GLP1 receptor agonists except for dulaglutide
13Patients who considered not eligible for the study by the attending doctor due to other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junko Hamai |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Endocrinology and Diabetes
Zip code
Address
6-16-1 Tomioka-higashi ,Kanazawa-ku,Yokohama,Kanagawa,236-0051,Japan
TEL
045-701-9581
femme-de-docilite@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Hamai |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Endocrinology and Diabetes
Zip code
Address
6-16-1 Tomioka-higashi ,Kanazawa-ku,Yokohama,Kanagawa,236-0051,Japan
TEL
045-701-9581
Homepage URL
femme-de-docilite@hotmail.co.jp
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory Center
Institute
Department
Personal name
Funding Source
Organization
not applicable
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
Address
Tel
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
神奈川県立循環器呼吸器病センター
Kanagawa Cardiovascular and Respiratory Center
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 02 | 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
Date of protocol fixation
| 2015 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 07 | 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 | 12 | Month | 02 | Day |
Last modified on
| 2017 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022941
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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