Efficacy and safety of using insulin glargine 300 U/mL in patients on advanced insulin therapy with type 1 or type 2 diabetes failing to achieve their glycemic targets. The Toujeo-Neo trial.

Assessment of Treatment Efficacy and Safety when switching the Basal component of any BOTplus or Basal-Bolus Regimen in Patients Failing to Reach Treatment Targets to Insulin glargine U300

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN93674355

Enrollment

2500

Registered

2019-02-27

Start date

2015-08-11

Completion date

Unknown

Last updated

2022-10-10

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

Conditions

Type 1 and type 2 diabetes mellitus in adult patients requiring insulin therapy. Nutritional, Metabolic, Endocrine

Interventions

All data were collected three times: at baseline, approximately 6 and approximately 12 months after starting insulin glargine 300 U/mL therapy. Baseline documentation (documentation 1) had to start im

i.e. actual dose and frequency of dose changes during the last four weeks. Data had to be generated during the daily clinical routine of the physicians. Any change in the patient’s antidiabetic therap

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with type 1 diabetes (basal-bolus insulin therapy) or type 2 diabetes (basal insulin plus 1-2x prandial insulin and oral antidiabetic drugs or basal-bolus insulin therapy) with any basal insulin except insulin glargine 300 U/mL. 2. Adults and Seniors: Age at least 18 years, no upper age limit. 3. HbA1c between 7.5% to 10.0%. 4. Fasting blood glucose > 130 mg/dL. 5. Ability and willingness to perform blood glucose self-monitoring.

Exclusion criteria

Exclusion criteria: 1. Contraindications for a therapy with insulin glargine 300 U/mL. 2. Patients receiving oral antidiabetic drug therapy only. 3. Patients receiving basal insulin and oral antidiabetic drugs without prandial insulin. 4. Patients with known cancer disease. 5. Pregnancy. 6. Drug or alcohol abuse. 7. Dementia or general incapacity to understand the content of the observational study.

Design outcomes

Primary

Measure	Time frame
Duration (persistency) of response defined as time from start of response to end of response. Beginning of response was defined by time of the first of at least two FBG values below or equal to 110 mg/dL or time of first HbA1c below or equal to predefined individual target value whichever occurred first. End of response was defined as one of the following: - the second FBG value >110 mg/dL (>6.1 mmol/L) after start of FBG response or - the first HbA1c value above the individual predefined target or - change to another form of insulin therapy or change of basal insulin.	—

Measure

Time frame

Duration (persistency) of response defined as time from start of response to end of response. Beginning of response was defined by time of the first of at least two FBG values below or equal to 110 mg/dL or time of first HbA1c below or equal to predefined individual target value whichever occurred first. End of response was defined as one of the following: - the second FBG value >110 mg/dL (>6.1 mmol/L) after start of FBG response or - the first HbA1c value above the individual predefined target or - change to another form of insulin therapy or change of basal insulin.

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Secondary

Measure	Time frame
1. Absolute change in HbA1c from baseline to 6 months to 12 months 2. Absolute change in FBG from baseline to 6 months to 12 months 3. Response rate 6 and 12 months after start of insulin glargine 300 U/mL treatment defined by: - Reaching two FBG values below or equal to 110 mg/dL or at least once the predefined individual HbA1c target value or - Reaching at least one HbA1c value equal or less to the predefined individual HbA1c target value OR - Reaching two FBG values below or equal to 110 mg/dL or - Reaching two FBG values below or equal to 110 mg/dL and at least once the predefined individual HbA1c target value. 4. Time from start of insulin glargine 300 U/mL treatment to response for each of the response endpoints 5. Incidence rates and rates per patient-year were calculated for symptomatic, confirmed symptomatic, nocturnal, severe, and severe nocturnal hypoglycemia as reported in the electronic Case Report Form (eCRF). Confirmation of symptomatic hypoglycemia was defined as self-measured blood glucose (SMBG) measurement below or equal to 70 mg/dL. Severe hypoglycemia was defined as necessity of the assistance of another person or an SMBG measurement of below or equal to 56 mg/dL. Nocturnal hypoglycemia occurring during the night (approximately 10pm-6am), while the patient was asleep (symptomatic or confirmed by SMBG measurement below or equal to 70 mg/dL). Severe nocturnal hypoglycemia was defined as those nocturnal hypoglycemia fulfilling the Definition of severe hypoglycemia. 95% CIs for incidence rates were calculated according to Clopper-Pearson. Rates per patient-year were calculated as a cumulative number of hypoglycemia events for all patients divided by the cumulative duration of insulin glargine 300 U/mL therapy in years, whereas patients with missing treatment duration or missing number of hypo	—

Measure

Time frame

1. Absolute change in HbA1c from baseline to 6 months to 12 months 2. Absolute change in FBG from baseline to 6 months to 12 months 3. Response rate 6 and 12 months after start of insulin glargine 300 U/mL treatment defined by: - Reaching two FBG values below or equal to 110 mg/dL or at least once the predefined individual HbA1c target value or - Reaching at least one HbA1c value equal or less to the predefined individual HbA1c target value OR - Reaching two FBG values below or equal to 110 mg/dL or - Reaching two FBG values below or equal to 110 mg/dL and at least once the predefined individual HbA1c target value. 4. Time from start of insulin glargine 300 U/mL treatment to response for each of the response endpoints 5. Incidence rates and rates per patient-year were calculated for symptomatic, confirmed symptomatic, nocturnal, severe, and severe nocturnal hypoglycemia as reported in the electronic Case Report Form (eCRF). Confirmation of symptomatic hypoglycemia was defined as self-measured blood glucose (SMBG) measurement below or equal to 70 mg/dL. Severe hypoglycemia was defined as necessity of the assistance of another person or an SMBG measurement of below or equal to 56 mg/dL. Nocturnal hypoglycemia occurring during the night (approximately 10pm-6am), while the patient was asleep (symptomatic or confirmed by SMBG measurement below or equal to 70 mg/dL). Severe nocturnal hypoglycemia was defined as those nocturnal hypoglycemia fulfilling the Definition of severe hypoglycemia. 95% CIs for incidence rates were calculated according to Clopper-Pearson. Rates per patient-year were calculated as a cumulative number of hypoglycemia events for all patients divided by the cumulative duration of insulin glargine 300 U/mL therapy in years, whereas patients with missing treatment duration or missing number of hypo

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026