UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for efficacy of DPP-4 inhibitor to mytonic dystrophy complicated diabetes mellitus by continuous glucose monitoring (CGM)
Title of the study (Brief title)	DPP-4 inhibitor to myotonic dystrophy: CGM observational study
Region	Japan

Condition
Condition	Myotonic dystrophy type 1
Classification by specialty	Endocrinology and Metabolism Neurology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate efficacy of DPP-4 inhibitor against myotonic dystrophy complicated diabetes mellitus.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation before and after administration of DPP-4 inhibitor. Index by CGM (mean blood sugar (BS), SD of BS, M value, MAGE, BS area, proportion of hypoglycemia or hyperglycemia) and routine blood examination.
Key secondary outcomes	Adverse event

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1.Genetically diagnosed 2.Fasting BS > 130mg/dl or 7.0% < HbA1c < 10.0% 3.Fasting serum C-peptide > 1.0mg/ml 4.Oral intake 5.Without limitation for stage or severity of disease
Key exclusion criteria	1.Medicated by insulin, DPP-4 inhibitor or GLP-1 agonist 2.Serious infection, perioperative or serious injury 3.Cardio-vascular event 4.Proronged QT on ECG 5.Serious liver damage 6.Moderate or serious renal damage 7.Moderate or serious heart failure 8.Gestation or lactation period 9.Short bowel syndrome 10.Medicated by steroid, interferon, hormonal agent, atypical antipsychotic, IA antiarrhythmic agent or III antiarrhythmic agent 11.Emaciation or skin disease with difficulty to be attached CGM 12.No informed consent with a form 13.Assessed as inadequate by a physician in charge
Target sample size	40

Research contact person
Name of lead principal investigator	Hiroto TAKADA
Organization	National Aomori Hospital
Division name	Neurology
Address	155-1 Namioka-Megasawa-Hirano, Aomori, Japan
TEL	+81-172-62-405
Email	takada@aomorihosp.jp

Public contact
Name of contact person	Hiroto TAKADA
Organization	National Aomori Hospital
Division name	Neurology
Address	155-1 Namioka-Megasawa-Hirano, Aomori, Japan
TEL	+81-172-62-405
Homepage URL	http://plaza.umin.ac.jp/~DM-CTG/index.html
Email	takada@aomorihosp.jp

Sponsor
Institute	Dystrophia Myotonica: Clinical Treatment Group
Institute
Department

Funding Source
Organization	MHLW(Japan) Health and labor science research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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	国立病院機構青森病院（青森県）Aomori National Hospital 国立病院機構刀根山病院（大阪府）Toneyama National Hospital 国立病院機構大牟田病院（福岡県）Omuta National Hospital 国立病院機構兵庫中央病院（兵庫県）Hyogo-chuo National Hospital 国立病院機構旭川医療センター（北海道）Asahikawa National Hospital 大阪大学大学院医学研究科（大阪府）Graduate school of medicine Osaka University

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 04 Month 16 Day
Anticipated trial start date	2015 Year 06 Month 15 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Related information
URL releasing protocol	http://plaza.umin.ac.jp/~DM-CTG/index.html
Publication of results	Unpublished
URL releasing results
Results
Other related information	Index by CGM (mean blood sugar (BS), SD of BS, M value, MAGE, BS area, proportion of hypoglycemia or hyperglycemia) and routine blood examination are observed.

Management information
Registered date	2015 Year 06 Month 03 Day
Last modified on	2018 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020620