UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045226
Receipt number R000050705
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
Date of disclosure of the study information 2021/08/23
Last modified on 2021/08/23 13:02:06

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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 or person

Institute

Akishima Clinic

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050705


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name