Comparison of a new formulation of insulin glargine with Lantus in patients with type 2 diabetes on non-insulin antidiabetic therapy

6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients with Type 2 Diabetes Mellitus not Adequately Controlled with Non-Insulin Antihyperglycemic Drugs with a 6-month Safety Extension Period - EDITION III

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000146-35-DK

Enrollment

1200

Registered

2012-08-23

Start date

2012-10-12

Completion date

Unknown

Last updated

2015-01-06

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

Conditions

Type 2 diabetes mellitus MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 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 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s); - Signed written informed consent. 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 900 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

Exclusion criteria: - HbA1c 11% (> 97 mmol/mol) [at screening]; - History of type 2 diabetes mellitus for less than 1 year before screening; - Less than 6 months before screening with non-insulin antihyperglycemic treatment; - Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening; - Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of GLP-1 receptor agonist in the last 6 months before screening visit; - Patients receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinides (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin, sulfonylurea and glinides are to be discontinued at baseline); - Current or previous insulin use except for a maximum of 8 consecutive days (e.g. acute illness, surgery) during the last year prior to screening; - Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (e.g. 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 at month 6, week 26) in patients with type 2 diabetes mellitus.;Secondary Objective: To compare a new formulation of insulin glargine and Lantus in terms of occurrence of nocturnal hypoglycemia;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 at month 6, week 26) in patients with type 2 diabetes mellitus.;Secondary Objective: To compare a new formulation of insulin glargine and Lantus in terms of occurrence of nocturnal hypoglycemia;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: Baseline, 6 months

—

Secondary

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

Countries

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

Contacts

Public ContactClinical Study Unit

sanofi-aventis Denmark A/S

clinicaltrialsinfo_denmark@sanofi-aventis.com+45 45167000

Outcome results

None listed

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