UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of ultralongacting insulin, glarugine and degludec in type 2 diabetes under basal-bolus insulin treatment
Acronym	Comparison of ultralongacting insulin, glarugine and degludec in type 2 diabetes under basal-bolus insulin treatment
Scientific Title	Comparison of ultralongacting insulin, glarugine and degludec in type 2 diabetes under basal-bolus insulin treatment
Scientific Title:Acronym	Comparison of ultralongacting insulin, glarugine and degludec in type 2 diabetes under basal-bolus insulin treatment
Region	Japan

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

Objectives
Narrative objectives1	To compare insulin glarugine and insulin degludec for efficancy in basal-bolus treatment in type 2 diabetes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of glucose variability between two treatments by the Continuous Glucose Monitoring System (Frequency of nocturnal hypoglycemia by basal-bolus insulin treatment with glarugine and degludec)
Key secondary outcomes	1)Standard deviation of nocturnal blood glucose levels 2)Correlation between ability of insulin secretion and Bolus/ Basal insulin ratio 3)Correlation between ability of insulin secretion and the frequency of nocturnal hypoglycemia

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Hospitalized patients with type 2 diabetes under Basal-Bolus insulin therapy with glargine will be enrolled. First CGMS for 72-h will be performed after fasting blood glucose are controlled to the range from 80mg/dl to 130mg/dl (First basal period). Then, Insulin glargine will be replaced to same dose decrutec without changing bolus insulin,and second CGMS will be performed.
Interventions/Control_2	Hospitalized patients with type 2 diabetes under Basal-Bolus insulin therapy with degludec will be enrolled. First CGMS for 72-h will be performed after fasting blood glucose are controlled to the range from 80mg/dl to 130mg/dl (First basal period). Then, Insulin decrutec will be replaced to same dose glargine without changing bolus insulin,and second CGMS will be performed.
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	Patients with type 2 diabetes who meet the following conditions: (1)Age: younger than 75 years old, elder than 20 years old (2)recent HbA1c : less than 12.0%
Key exclusion criteria	Patients who falls under any of the following conditions shall be excluded: (1)diabetic coma (2)severe renal dysfunction (eGFR less than 30) (3)unstable pre or proliferative diabetic retinopathy (4)severe infection (5)administered steroid drugs (6)pregnant or planned pregnant in the near future (7)ineligible for some other medical reasons judged by the investigator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Kawashima
Organization	Naga Municipal Hospital
Division name	Department of Internal Medicine
Zip code	649-6414
Address	1282 Uchita, Kinokawa City, Wakayama 649-6414, Japan
TEL	0736772019
Email	soumu@nagahp.jp

Public contact
Name of contact person	1st name Tetsushi Middle name Last name Nasu
Organization	Naga Municipal Hospital
Division name	Department of Internal Medicine
Zip code	649-6414
Address	1282 Uchita, Kinokawa City, Wakayama 649-6414, Japan
TEL	0736772019
Homepage URL
Email	soumu@nagahp.jp

Sponsor
Institute	Naga Municipal Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Naga Municipal Hospital
Address	1282 Uchita, Kinokawa City, Wakayama 649-6414, Japan
Tel	0736772019
Email	soumu@nagahp.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	公立那賀病院内科 Department of Internal Medicine, Naga Municipal Hospital

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 19 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	Terminated
Date of protocol fixation	2013 Year 04 Month 15 Day
Date of IRB	2013 Year 04 Month 16 Day
Anticipated trial start date	2013 Year 04 Month 19 Day
Last follow-up date	2013 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 04 Month 17 Day
Last modified on	2020 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012300