UMIN-CTR Clinical Trial

Basic information
Public title	Effects of treatment with SGLT2 inhibitor on the initiation of continuous positive airway pressure therapy in type 2 diabetic patients with obstructive sleep apnea syndrome
Acronym	Effects of treatment with SGLT2 inhibitor on the initiation of C-PAP therapy in type 2 diabetic patients with obstructive sleep apnea syndrome
Scientific Title	Effects of treatment with SGLT2 inhibitor on the initiation of continuous positive airway pressure therapy in type 2 diabetic patients with obstructive sleep apnea syndrome
Scientific Title:Acronym	Effects of treatment with SGLT2 inhibitor on the initiation of C-PAP therapy in type 2 diabetic patients with OSAS
Region	Japan

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

Objectives
Narrative objectives1	To follow the effects of SGLT2 inhibitor in type 2 diabetic patients having obstructive sleep apnea syndrome at initiation of C-PAP therapy for 3 months.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c, BMI, and apnea-hypopnea index
Key secondary outcomes	Serum lipid profile, serum parameters of hepatic function, and serum uric acid level

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The type 2 diabetic patients having obstructive sleep apnea syndrome are treated with 2.5 mg/day luseogliflozin, 5 mg/day dapagliflozin, or 10 mg/day empagliflozin for more than 6 months. And then the glycemic control of the patients is followed for 3 months without C-PAP therapy.
Interventions/Control_2	The type 2 diabetic patients having obstructive sleep apnea syndrome are treated with 2.5 mg/day luseogliflozin, 5 mg/day dapagliflozin, or 10 mg/day empagliflozin for more than 6 months, and then are initiated on C-PAP therapy. The glycemic control of the patients is followed for 3 months.
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	18 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Hemoglobin A1c level: 6.5-9.5%
Key exclusion criteria	eGFR<45 mL/min/1.73 m2
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Masataka Middle name Last name Kusunoki
Organization	Nagoya University
Division name	Research Center of Health, Physical Fitness and Sports
Zip code	464-8601
Address	Furo-cho, Chikusa-ku, Nagoya
TEL	052-789-3946
Email	kusunoki@tonyo.jp

Public contact
Name of contact person	1st name Masataka Middle name Last name Kusunoki
Organization	Nagoya University
Division name	Research Center of Health, Physical Fitness and Sports
Zip code	464-8601
Address	Furo-cho, Chikusa-ku, Nagoya
TEL	052-789-3946
Homepage URL
Email	kusunoki@tonyo.jp

Sponsor
Institute	Akishima Clinic
Institute
Department

Funding Source
Organization	Akishima Clinic
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	Akishima Clinic
Address	4-2-29 Sakae, Naka-ku, Nagoya
Tel	052-243-1024
Email	info@tonyo.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	医療法人社団織田会あきしまクリニック（愛知県）

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 23 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	16
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	2020 Year 03 Month 01 Day
Date of IRB	2020 Year 03 Month 20 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 04 Month 30 Day
Date trial data considered complete	2021 Year 05 Month 31 Day
Date analysis concluded	2021 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2021 Year 08 Month 23 Day
Last modified on	2021 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050705