UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and Safety of Insulin Glargine 300 U/mL versus Insulin Degludec in Patients with Type 2 Diabetes: A Randomized, Open-Label, Crossover Study Using Continuous Glucose Monitoring Profiles
Title of the study (Brief title)	Efficacy and Safety of Insulin Glargine 300 U/mL versus Insulin Degludec in Patients with Type 2 Diabetes: A Randomized, Open-Label, Crossover Study Using Continuous Glucose Monitoring Profiles
Region	Japan

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

Objectives
Narrative objectives1	Comparison of the efficacy and safety of insulin glargine 300U/ml, insulin deguldec.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoints of this study included the efficacy and safety outcomes based on the CGM parameters. The efficacy outcome was the mean percentage of time within the predefined CGM glucose range of 70-180 mg/dl, expressed as target range, for 3 consecutive days of each treatment period. The safety outcome was the mean percentage of time with glucose < 70 mg/dl, expressed as hypoglycemia range.
Key secondary outcomes	Secondary endpoints based on CGM included the 24h mean glucose level, nocturnal (0:00-6:00) mean glucose level, morning (8:00-12:00) mean glucose level, afternoon (12:00-24:00) mean glucose level, 24h standard deviation (SD) of the glucose levels, 24h M-value (target glucose level 100 mg/dl), the mean percentage of time with severe hypoglycemia (< 54 mg/dl), with nocturnal (0:00-6:00) hypoglycemia (< 70 mg/dl), and with hyperglycemia (> 180 mg/dl) for 3 consecutive days. The mean amplitude of glycemic excursion (MAGE) was calculated from the CGM data taking into account the glycemic peaks and nadirs recorded over a 24h period for 3 consecutive days. The mean of daily difference (MODD) for a 24h period was used as an index of day-to-day glucose variability.

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	In brief, participants previously treated with OADs continued their prestudy OAD treatment without any change in dose or regimen. The starting dose of Gla300 or Deg for basal insulin-naive participants was 4 units. Participants receiving basal insulin prior to the study were switched to Gla300 or Deg on a unit-for-unit dose basis without any change of bolas insulin. Participants receiving premixed insulin prior to the study were switched to basal/bolus insulin therapy with Gla300 or Deg, and the short-acting insulin on the same dose of intermediate-acting and short-acting insulin included in premixed insulin. After that, on the basis of self-monitoring of blood glucose (SMBG), basal insulin doses were titrated to a target pre-prandial glucose concentration of 100-130 mg/dl at breakfast. The basal insulin dose was titrated no more often than every 3 to 4 days. Bolus insulin was titrated using each pre-meal glycemia and pre-bedtime blood glucose 100-130 mg / dl. After determining the amount of insulin, it was confirmed that the blood glucose fluctuation by SMBG before breakfast, before lunch, before dinner and before going to bed was stabilized within 3 percentage or more and within 10 percentage, respectively, and there was no hypoglycemia. After obtain good and stable glycemic control, we evaluated their glycemic control in a blinded fashion using a CGM for consecutive five days.
Interventions/Control_2	Subsequently, their basal insulin was switched from Gla300 to Deg and vice versa, in the treatment period. After washout of former basal insulin for more than 3 to 4 days confirmed by SMBG profile, we again evaluated their glycemic control using CGM for consecutive 5 days. CGM recorded glucose values for the last 5 days in each treatment period, and we used 3 days in the middle to complete 24h recording sets. Each participant was given the following hospital diets with the same calorie and carbohydrate amount for individual: 25-30 kcal/ideal body weight/day with the certain component ration of calories (carbohydrate 60%, proteins 17%, and lipids 23%; breakfast 30%, lunch 35%, supper 35%).
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Minamiosaka hospital for the purpose of glycemic control and education.
Key exclusion criteria	1.Serious ketosis, history of diabetic coma or precoma 2.Pregnancy or lactation and patients scheduled 3.Serious infection, trauma, undergo surgery 4.Receiving steroid therapy. 5.Severe liver dysfunction 6.Type 1 diabetes 7.Hypersensitivity to degludec/aspart, glargin, glulisine. 8.History of malignancy or malignancy. 9.Judged to be unsuitable for participation for medical reasons.
Target sample size	30

Research contact person
Name of lead principal investigator	Yuji Kawaguchi
Organization	Minamiosaka Hospital
Division name	Internal medicine
Address	1-18-18,higashikagaya,suminoe-ku,Osaka,559-0012,Japan
TEL	06-6685-0221
Email	y.kawaguchi@minamiosaka.com

Public contact
Name of contact person	Yuji Kawaguchi
Organization	Minamiosaka Hospital
Division name	Internal medicine
Address	1-18-18,higashikagaya,suminoe-ku,
TEL	06-6685-0221
Homepage URL
Email	y.kawaguchi@minamiosaka.com

Sponsor
Institute	Minamiosaka Hospital
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)

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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2016 Year 11 Month 24 Day
Date of closure to data entry	2017 Year 02 Month 02 Day
Date trial data considered complete	2017 Year 10 Month 01 Day
Date analysis concluded	2017 Year 11 Month 13 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 29 Day
Last modified on	2019 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035437