Comparison of morning Basal + 1 rapid insulin therapy (Insulin Glulisine + Insulin glargine 300 U/ml vs. Insulin lispro + Insulin glargine BS) using continuous glucose monitoring (CGM):randomised crossover study

Comparison of morning Basal + 1 rapid insulin therapy (Insulin Glulisine + Insulin glargine 300 U/ml vs. Insulin lispro + Insulin glargine BS) using continuous glucose monitoring (CGM):randomised crossover study - Comparison of Insulin Glulisine + Insulin glargine 300 U/ml vs. Insulin lispro + Insulin glargine BS using CGM

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022094

Enrollment

Registered

2016-05-02

Start date

2016-05-02

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

CGM is attached after admission. Insulin Glulisine + Insulin glargine 300 U/ml are used on day 1 and day 2. Then, therapy is swhiched to Insulin lispro + Insulin glargine biosimilar on day 3 and day 4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: type 2 diabetic patients medicated basal insulin therapy for 3 month or longer

Exclusion criteria

Exclusion criteria: severe renal dysfunction (serum creatinine level over 2.0 mg/dL) judged to be unsuitable for participation for medical reasons

Design outcomes

Primary

Measure	Time frame
CGM M-value(24:00, 8:00-12:00, 12:00-24:00, 0:00-8:00) MAGE MODD mean glucose level(24:00, 8:00-12:00, 12:00-24:00, 0:00-8:00) SD(24:00, 8:00-12:00, 12:00-24:00, 0:00-8:00) Preprandial glucose level Highest postprandial glucose level within 3 hours after each meal Time from start of meal to the highest postprandial glucose level Differences between preprandial and highest postprandial glucose level for each meal post-breakfast glucose gradient AUC (over 180 mg/dL) for glycemic variability within 3 h of each meal AUC (over 0 mg/dL) for glycemic variability in 24 h AOC (under 70 mg/dL) for glycemic variability, mg.min/dL(24:00, 8:00-12:00, 0:00-8:00)	—

Measure

Time frame

CGM M-value(24:00, 8:00-12:00, 12:00-24:00, 0:00-8:00) MAGE MODD mean glucose level(24:00, 8:00-12:00, 12:00-24:00, 0:00-8:00) SD(24:00, 8:00-12:00, 12:00-24:00, 0:00-8:00) Preprandial glucose level Highest postprandial glucose level within 3 hours after each meal Time from start of meal to the highest postprandial glucose level Differences between preprandial and highest postprandial glucose level for each meal post-breakfast glucose gradient AUC (over 180 mg/dL) for glycemic variability within 3 h of each meal AUC (over 0 mg/dL) for glycemic variability in 24 h AOC (under 70 mg/dL) for glycemic variability, mg.min/dL(24:00, 8:00-12:00, 0:00-8:00)

—

Countries

Japan

Contacts

Public ContactTakeishi Soichi

General Inuyamachuo Hospital Department of Diabetes

souichi19811225@yahoo.co.jp0568-62-8111

Outcome results

None listed

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