UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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	Junko Hamai
Organization	Kanagawa Cardiovascular and Respiratory Center
Division name	Department of Endocrinology and Diabetes
Address	6-16-1 Tomioka-higashi ,Kanazawa-ku,Yokohama,Kanagawa,236-0051,Japan
TEL	045-701-9581
Email	femme-de-docilite@hotmail.co.jp

Public contact
Name of contact person	Junko Hamai
Organization	Kanagawa Cardiovascular and Respiratory Center
Division name	Department of Endocrinology and Diabetes
Address	6-16-1 Tomioka-higashi ,Kanazawa-ku,Yokohama,Kanagawa,236-0051,Japan
TEL	045-701-9581
Homepage URL
Email	femme-de-docilite@hotmail.co.jp

Sponsor
Institute	Kanagawa Cardiovascular and Respiratory Center
Institute
Department

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 10 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022941