UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of dulaglutide therapy for the inpatient management of general medicine patients with type 2 diabetes
Title of the study (Brief title)	Safety and efficacy of dulaglutide therapy for the inpatient management of general medicine 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	This study investigates the safety and efficacy of dulaglutide therapy for the inpatient management of type 2 diabetes in general medicine patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Index of glycemic variability
Key secondary outcomes	number of BG values within range, number of hypoglycemic events, number of episodes of hyperglycemia, TTD of insulin, length of hospital stay, hospital complications

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	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Dulaglutide plus basal insulin group: this group receives dulaglutide once weekly with basal insulin once daily and supplemental dose of regular insulin. Study term is 8days after hospitalization.
Interventions/Control_2	Basal insulin group: this group receives basal insulin once daily and supplermental dose of regular insulin during study term.
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	15 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Recruited patients had a known history of type 2 diabetes (T2D) with a blood glucose (BG) between 140 and 400 mg/dL and a known history of T2D for over 3 months, and were treated diet alone, any combination of oral antidiabetic agents, or low-dose insulin therapy.
Key exclusion criteria	Patients admitted to or expected to require ICU admission; Patients with basal-bolus insulin therapy, corticosteroid therapy,therapy of another once weekly antidiabetic agents, clinically relevant gastrointestinal disease, impaired renal function (serum creatinine >3.0 mg/dL); and patients with a history of diabetic ketoacidosis and hyperglycemic crises pregnancy, or any mental condition rendering the subject unable to give informed consent.
Target sample size	40

Research contact person
Name of lead principal investigator	Nobutoshi Fushimi
Organization	Ichinomiyanishi hospital
Division name	Department of Endocrinology and Diabetes
Address	1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
TEL	0586-48-0077
Email	nobutoshi243@yahoo.co.jp

Public contact
Name of contact person	Nobutoshi Fushimi
Organization	Ichinomiyanishi hospital
Division name	Department of Endocrinology and Diabetes
Address	1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
TEL	0586-48-0077
Homepage URL
Email	nobutoshi243@yahoo.co.jp

Sponsor
Institute	Ichinomiyanishi hospital
Institute
Department

Funding Source
Organization	nothing
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

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 01 Day
Anticipated trial start date	2016 Year 12 Month 01 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	2016 Year 11 Month 26 Day
Last modified on	2018 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028027