UMIN-CTR Clinical Trial

Public title

Comparison of daily glucose excursion by continuous glucose monitoring between type 2 diabetic patients receiving biphasic insulin aspart 30 or biphasic human insulin 30

Acronym

Comparison of daily glucose excursion by continuous glucose monitoring between type 2 diabetic patients receiving biphasic insulin aspart 30 or biphasic human insulin 30

Scientific Title

Comparison of daily glucose excursion by continuous glucose monitoring between type 2 diabetic patients receiving biphasic insulin aspart 30 or biphasic human insulin 30

Scientific Title:Acronym

Comparison of daily glucose excursion by continuous glucose monitoring between type 2 diabetic patients receiving biphasic insulin aspart 30 or biphasic human insulin 30

Region

Japan

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Biphasic insulin aspart 30 (BIAsp30) has an earlier and stronger peak effect with a similar duration of action to biphasic human insulin 30 (BHI30). However, direct comparison of daily glucose excursion during treatment with these two types of insulin has not been done.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Assessment of CGM Parameters and Data Analysis
After downloading the recorded data, the following parameters were analyzed from the intermediate 48 hours of data: average glucose level (AG), standard deviation (SD) of glucose, mean amplitude of glucose excursion (MAGE), area under the glucose curve (AUC-glu) during the 30-min period before each meal, at 1-2 hour, 2-3 hour, and 3-4 hour after each meal, and during the night (10PM to 7AM), and area under the curve of incremental (baseline-corrected) postprandial glucose from just before to 4 hours after each meal (IAUC0-4h).

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

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

BIAsp30 to BHI30
After enrollment, patients were randomized to the BIAsp30 group or BHI30 group. Then, sulfonylurea therapy was suspended and insulin was started twice daily (before breakfast and dinner) at the outpatient clinic. BIAsp30 and BHI30 were injected just before meals and 30 min before meals, respectively. The insulin dosage was adjusted to achieve individual target levels, which were set by the attending physician considering each patients clinical condition.

Interventions/Control_2

BHI30 to BIAsp30

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

18

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

type2 DM
Inclusion criteria were stable but inadequate glycemic control (HbA1c>7.8% and variation of HbA1c by <0.5% within 3 months before enrollment) and treatment with a sulfonylurea only (not insulin with or without other oral antidiabetic agents).

Key exclusion criteria

The exclusion criteria included pregnancy, severe medical illnesses, anemia, renal failure (serum creatinine>2.0 mg/dl), overt proteinuria, chronic liver disease, thyroid disease, malignancy, or severe hypoglycemia requiring assistance within the previous 6 months.

Target sample size

12

Name of lead principal investigator

1st name
Middle name
Last name	Akio Ohta

Organization

St. Marianna University School of Medicine

Division name

Department of Internal Medicine, Division of Metabolism and Endocrinology

Zip code

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

St. Marianna University School of Medicine

Division name

Department of Internal Medicine, Division of Metabolism and Endocrinology

Zip code

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan

TEL

Homepage URL

Email

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name

Organization

No source

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

2011

Year

02

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

2010

Year

05

Month

01

Day

Date of IRB

Anticipated trial start date

2010

Year

05

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

02

Month

23

Day

Last modified on

2011

Year

02

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006089