Study to assess the efficacy and safety of a basal insulin (Glargine 300) on glycemic control type 2 diabetic patients during hospitalization and at discharge.

Phase IV study to evaluate the safety and efficacy of the treatment of hyperglycemia with Gla-300 in basal-bolus regimen in hospitalised T2D patients poorly controlled with basal insulin and/or non-insulin treatments and therapy intensification at discharge with basal insulin . - COBALTA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004715-20-ES

Enrollment

106

Registered

2016-01-13

Start date

2016-02-25

Completion date

Unknown

Last updated

2018-08-20

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

Conditions

Type 2 Diabetes MedDRA version: 18.1 Level: LLT Classification code 10049746 Term: Insulin-requiring type II diabetes mellitus System Organ Class: 100000004861

Interventions

Trade Name: Toujeo Product Name: Insulin glargine Product Code: HOE901 - U300 Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: INSULIN GLARGINE CAS Number: 160337-95-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subjects >18 and =65 years) yes F.1.3.1 Number of subjects for this age range 46

Exclusion criteria

Exclusion criteria: - Type 1 Diabetes Mellitus. - Admission to hospital for decompensation of diabetes. - Any psychiatric or neurological disability preventing follow-up - Critical illness. - Previous treatment with premix or rapid acting insulin (except for treatment of gestational diabetes or brief treatment with insulin for less than 1 week). - Glomerular filtration rate (GFR) < 30 ml/min measured by MDRD-4 equation. -Very high-risk patients who need mandatory insulin therapy at discharge (Treatment with corticoesteroids or pancreatic insufficiency (Pancreatitis / surgery). -Participation in any other study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of intensifying treatment at discharge with basal insulin strategy in hospitalised T2D patients poorly controlled with basal insulin and/or non-insulin treatments (HbA1c >=8.0 % on admission) measured by the decrease in HbA1c from discharge to month 6.;Secondary Objective: To evaluate the efficacy and safety of Gla-300 in basal-bolus regimen during hospitalization measured by in-patient blood glucose profile. To evaluate fasting plasma glucose at 3 and 6 months post-discharge. To evaluate the change in body weight from discharge to month 6. To evaluate patients' satisfaction with the study treatment. To know the incidence of confirmed or severe hypoglycemia during hospitalization and 6 months post-discharge. To study overall safety during hospitalization and 6 months post-discharge. All serious and non-serious adverse event and product technical complaints (device related) will be collected. To determine episodes of re-hospitalization or unexpected visits to the emergency room during 6 months post-discharge.;Primary end point(s): Mean change in HbA1c from discharge to 6 months.;Timepoint(s) of evaluation of this end point: From discharge to 6 months.	—

Measure

Time frame

Main Objective: To evaluate the effect of intensifying treatment at discharge with basal insulin strategy in hospitalised T2D patients poorly controlled with basal insulin and/or non-insulin treatments (HbA1c >=8.0 % on admission) measured by the decrease in HbA1c from discharge to month 6.;Secondary Objective: To evaluate the efficacy and safety of Gla-300 in basal-bolus regimen during hospitalization measured by in-patient blood glucose profile. To evaluate fasting plasma glucose at 3 and 6 months post-discharge. To evaluate the change in body weight from discharge to month 6. To evaluate patients' satisfaction with the study treatment. To know the incidence of confirmed or severe hypoglycemia during hospitalization and 6 months post-discharge. To study overall safety during hospitalization and 6 months post-discharge. All serious and non-serious adverse event and product technical complaints (device related) will be collected. To determine episodes of re-hospitalization or unexpected visits to the emergency room during 6 months post-discharge.;Primary end point(s): Mean change in HbA1c from discharge to 6 months.;Timepoint(s) of evaluation of this end point: From discharge to 6 months.

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Secondary

Measure	Time frame
Secondary end point(s): Efficacy secondary end points: - % of hyperglycemia (>200 mg/dl), and glycemia exceeding objectives (Glycemia preprandial >130 and posprandial >180 mg/dl) of the four BG measurements per day during hospitalization and seven BG measurements at the beginning and end of hospitalisation (mg/dl). - Mean change in fasting plasma glucose during hospitalization and from discharge to month 3 and 6. - Body weight measurements at discharge and month 6. - Mean change in HbA1c from discharge to 6 months across patients with baseline HbA1c below or above 9%. Clinical status on discharge: - Hyperglycaemia-provoking factors - Contraindications and risk of hypoglycaemic agents - Insulin during hospital stay: basal, bolus and correction insulin doses in the 24 hours prior to discharge. Treatment on discharge: - Medication, dose and frequency at discharge and 6 months after discharge - Mean change in Gla-300 dose during hospitalization and from discharge to month 3 and 6. Satisfaction with treatment: Average DTSQ total treatment satisfaction, hyperglycemia perception and hypoglycaemia perception scores will be described at month 6.. Safety: - Number and proportion of patients experiencing >= 1 episode of documented hypoglycaemia and number of documented and severe hypoglycaemic events per patient-year during hospitalization and between discharge and 6-month follow-up. Any hypglycaemic event at any time during day and night will be analyzed. (A Documented Hypoglycemic Episode is defined as an event during which typical symptoms of hypoglycemia or not are accompanied by a measured plasma glucose concentration < 70 mg/dl (3.9 mmol/l)) - All serious and non-serious adverse event and product technical complaints (device related) will be collected. - Episodes of re-hospitalization or unexpected visits to hospital from discharge to month 6.;Timepoint(s) of evaluation of this end point: During hospitalization and between discharge and 6-month.	—

Measure

Time frame

Secondary end point(s): Efficacy secondary end points: - % of hyperglycemia (>200 mg/dl), and glycemia exceeding objectives (Glycemia preprandial >130 and posprandial >180 mg/dl) of the four BG measurements per day during hospitalization and seven BG measurements at the beginning and end of hospitalisation (mg/dl). - Mean change in fasting plasma glucose during hospitalization and from discharge to month 3 and 6. - Body weight measurements at discharge and month 6. - Mean change in HbA1c from discharge to 6 months across patients with baseline HbA1c below or above 9%. Clinical status on discharge: - Hyperglycaemia-provoking factors - Contraindications and risk of hypoglycaemic agents - Insulin during hospital stay: basal, bolus and correction insulin doses in the 24 hours prior to discharge. Treatment on discharge: - Medication, dose and frequency at discharge and 6 months after discharge - Mean change in Gla-300 dose during hospitalization and from discharge to month 3 and 6. Satisfaction with treatment: Average DTSQ total treatment satisfaction, hyperglycemia perception and hypoglycaemia perception scores will be described at month 6.. Safety: - Number and proportion of patients experiencing >= 1 episode of documented hypoglycaemia and number of documented and severe hypoglycaemic events per patient-year during hospitalization and between discharge and 6-month follow-up. Any hypglycaemic event at any time during day and night will be analyzed. (A Documented Hypoglycemic Episode is defined as an event during which typical symptoms of hypoglycemia or not are accompanied by a measured plasma glucose concentration < 70 mg/dl (3.9 mmol/l)) - All serious and non-serious adverse event and product technical complaints (device related) will be collected. - Episodes of re-hospitalization or unexpected visits to hospital from discharge to month 6.;Timepoint(s) of evaluation of this end point: During hospitalization and between discharge and 6-month.

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Countries

Spain

Contacts

Public ContactUnidad Estudios Clínicos

SANOFI-AVENTIS, S.A.

ES-unidadestudiosclinicos@sanofi.com003493485 94 00

Outcome results

None listed

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