UMIN-CTR Clinical Trial

Basic information
Public title	A pilot study on prevention of glucocorticoid induced diabetes mellitus by linagliptin
Acronym	A pilot study on prevention of glucocorticoid induced diabetes mellitus by linagliptin (P-GDM-Lina)
Scientific Title	A pilot study on prevention of glucocorticoid induced diabetes mellitus by linagliptin
Scientific Title:Acronym	A pilot study on prevention of glucocorticoid induced diabetes mellitus by linagliptin (P-GDM-Lina)
Region	Japan

Condition
Condition	Patients scheduled administration of glucocorticoid
Classification by specialty	Medicine in general Nephrology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety for prevention of glucocorticoid induced diabetes mellitus by linagliptin
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Proportion of development of glucocorticoid induced diabetes mellitus within 1 month
Key secondary outcomes	Concomitant insulin use Concomitant anti-diabetic drug Adverse effect Change in HbAic Change in HOMA-IR Change in glycoalbumin Change in 1.5-AG Change in adiponectin Change in glucagon Change in cortisol Change in leptin Change in serum and urine CPR

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Concomitant administration of linagliptin at start of GC administration
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Administration of 20mg/day or more of prednisone is scheduled 2) Not fulfilled below criteria for diabetes mellitus a) HbA1c >= 6.5 % b) fasting blood glucose level >= 126 mg/dL c) blood glucose level at 2hr on OGTT >= 200mg/dL or casual blood glucose level >= 200mg/dL 3) At least either one of following risk factor for glucocorticoid induced diabetes mellitus a) eGFR =< 60ml/min/1.73m2 b) 65 year or older c) HbA1c > 6.0 % 4) Informed consent is obtained
Key exclusion criteria	1) < 20 years old 2) Inability of internal use 3) Pregnancy 4) Glucocorticoid pulse therapy is scheduled 5) Malignancy
Target sample size	17

Research contact person
Name of lead principal investigator	1st name Ken-ei Middle name Last name Sada
Organization	Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.
Division name	Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan
TEL	086-235-7235
Email	sadakenn@okayama-u.ac.jp

Public contact
Name of contact person	1st name Yoshia Middle name Last name Miyawaki
Organization	Okayama University Graduate Schoolof of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558, Japan
TEL	086-235-7235
Homepage URL
Email	yoshia0316@gmail.com

Sponsor
Institute	Department of Nephrology, Rheumatology, Endocrinology and Metabolism, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.
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	Okayama University
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
Tel	86-235-7361
Email	ouh-crrb@adm.okayama-u.ac.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	岡山大学病院

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 24 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	2014 Year 12 Month 24 Day
Date of IRB	2014 Year 12 Month 24 Day
Anticipated trial start date	2014 Year 12 Month 24 Day
Last follow-up date	2016 Year 02 Month 28 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 04 Month 30 Day
Date analysis concluded	2016 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 11 Month 02 Day
Last modified on	2020 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018116