Comparison of a new formulation of insulin glargine with Lantus in patients with type 1 diabetes mellitus

A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected in the Morning or Evening in Patients with Type 1 Diabetes Mellitus with a 6-month Safety Extension Period - EDITION IV

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001524-35-DK

Enrollment

577

Registered

2012-08-23

Start date

2012-10-12

Completion date

Unknown

Last updated

2015-08-31

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

Conditions

Type 1 diabetes mellitus MedDRA version: 18.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Code: HOE901-new formulation Pharmaceutical Form: Solution for injection in cartridge INN or Proposed INN: INSULIN GLARGINE CAS Number: 160337-95-1 Current Sponsor code: HOE901 - new formulati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult Patients with type 1 diabetes mellitus Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 550 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: - HbA1c 10% (86 mmol/mol) at screening; - Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit; - Patients not on stable insulin dose (±20% total basal insulin dose) in the last 30 days prior to screening visit; - Patients using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit; - Use of an insulin pump in the last 6 months before screening visit and no plan to switch to insulin pump in the next 12 months; - Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening; - Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit; - Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled month 6) in patients with type 1 diabetes mellitus;Secondary Objective: To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose, pre-injection plasma glucose, 8-point self-measured plasma glucose profile;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: Baseline, 6 months	—

Measure

Time frame

Main Objective: To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled month 6) in patients with type 1 diabetes mellitus;Secondary Objective: To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose, pre-injection plasma glucose, 8-point self-measured plasma glucose profile;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: Baseline, 6 months

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Secondary

Measure	Time frame
Secondary end point(s): - Change in Pre-injection plasma glucose - Change in Fasting plasma glucose - Change in 8-point self-monitored plasma glucose profile - Hypoglycemia;Timepoint(s) of evaluation of this end point: Baseline, 6 months for : - Change in Pre-injection plasma glucose - Change in Fasting plasma glucose - Change in 8-point self-monitored plasma glucose profile 6 months for : - Hypoglycemia	—

Measure

Time frame

Secondary end point(s): - Change in Pre-injection plasma glucose - Change in Fasting plasma glucose - Change in 8-point self-monitored plasma glucose profile - Hypoglycemia;Timepoint(s) of evaluation of this end point: Baseline, 6 months for : - Change in Pre-injection plasma glucose - Change in Fasting plasma glucose - Change in 8-point self-monitored plasma glucose profile 6 months for : - Hypoglycemia

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Countries

Canada, Czech Republic, Denmark, Estonia, Finland, Hungary, Japan, Latvia, Netherlands, Puerto Rico, Sweden, United States

Contacts

Public ContactClinical Study Unit

sanofi-aventis Danmark A/S

clinicaltrialsinfo_denmark@sanofi-aventis.com+45 45 167000

Outcome results

None listed

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