UMIN-CTR Clinical Trial

Public 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

Acronym

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

Scientific 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

Scientific Title:Acronym

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

diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yuji Kawaguchi

Organization

Minamiosaka Hospital

Division name

Internal medicine

Zip code

Address

1-18-18,higashikagaya,suminoe-ku,Osaka,559-0012,Japan

TEL

06-6685-0221

Email

y.kawaguchi@minamiosaka.com

Name of contact person

1st name
Middle name
Last name	Yuji Kawaguchi

Organization

Minamiosaka Hospital

Division name

Internal medicine

Zip code

Address

1-18-18,higashikagaya,suminoe-ku,

TEL

06-6685-0221

Homepage URL

Email

y.kawaguchi@minamiosaka.com

Institute

Minamiosaka Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

01

Month

29

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

05

Month

01

Day

Date of IRB

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

Other related information

Registered date

2018

Year

01

Month

29

Day

Last modified on

2019

Year

02

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035437