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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005129

Enrollment

Registered

2011-02-23

Start date

2010-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes

Interventions

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 di

Eligibility

Sex/Gender

All

Inclusion criteria

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).

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026