UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of linagliptin for glycemic control in non-critically ill hospitalized patients with type 2 diabetes
Acronym	Safety and efficacy of linagliptin for glycemic control in non-critically ill hospitalized patients
Scientific Title	Safety and efficacy of linagliptin for glycemic control in non-critically ill hospitalized patients with type 2 diabetes
Scientific Title:Acronym	Safety and efficacy of linagliptin for glycemic control in non-critically ill hospitalized patients
Region	Japan

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

Objectives
Narrative objectives1	To investigate safety and efficasy of linagliptin for glycemic control in hospitalized patients with type 2 diabetes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of target glucose rage
Key secondary outcomes	mean blood glucose (BG), glycemic variability (GV), percentage of hypoglycemia, percentage of BG over 200 mg/dl, side effect

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
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 linagliptin once daily with basal insulin once daily and supplemental dose of regular insulin. Study term is 7 days 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	20 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 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	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobutoshi Fushimi
Organization	Ichinomiyanishi Hospital
Division name	Department of Endocrinology and Diabetes
Zip code
Address	1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
TEL	0586480077
Email	nobutoshi243@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Matsubara Akihiro
Organization	Ichinomiyanishi Hospital
Division name	Research Planning Division
Zip code
Address	1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
TEL	0586480077
Homepage URL
Email	nobutoshi243@yahoo.co.jp

Sponsor
Institute	Ichinomiyanishi Hospital
Institute
Department

Funding Source
Organization	nothing
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2018 Year 11 Month 05 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	Completed
Date of protocol fixation	2018 Year 08 Month 01 Day
Date of IRB	2018 Year 02 Month 15 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date	2019 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 11 Month 05 Day
Last modified on	2021 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038256