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

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 - 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031044

Enrollment

Registered

2018-01-29

Start date

2016-06-01

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

diabetes

Interventions

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 participant

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Minamiosaka hospital for the purpose of glycemic control and education.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactYuji Kawaguchi

Minamiosaka Hospital Internal medicine

y.kawaguchi@minamiosaka.com06-6685-0221

Outcome results

None listed

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