Comparison of a new formulation of insulin glargine with Lantus in patients with type 2 diabetes on basal insulin with oral 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® both in combination with oral antihyperglycemic drug(s) in Patients with Type 2 Diabetes Mellitus with a 6 month Safety Extension Period

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023770-39-DE

Enrollment

800

Registered

2011-09-29

Start date

2011-10-28

Completion date

Unknown

Last updated

2015-01-26

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: 16.0 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 pre-filled pen INN or Proposed INN: Insulin glargine CAS Number: 160337-95-1 Current Sponsor code: HOE901 - new form

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with type 2 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 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: o Age 10% at screening; o Diabetes other than type 2 diabetes mellitus; o Less than 6 months on basal insulin treatment together with oral antihyperglycemic drugs and self-monitoring of blood glucose; o Patients using sulfonylurea in the last 2 months before screening visit; o Any contraindication to use of insulin glargine as defined in the national product label; o Use of insulin pump in the last 6 months before screening; o Initiation of new glucose-lowering medications in the last 3 months before screening visit; o History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period; o Pregnant or breast-feeding women or women who intend to become pregnant during the study period

Design outcomes

Primary

Measure	Time frame
Main Objective: Change in HbA1c from baseline to endpoint (scheduled month 6);Secondary Objective: Hypoglycemia;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: 6 months	—

Secondary

Measure	Time frame
Secondary end point(s): Up to 6 months : - Incidence of patients (%) with at least one nocturnal hypoglycemia between start of week 9 and endpoint, indicated as severe and/or confirmed by plasma glucose = 70 mg/dL (3.9 mmol/L) which occurred between 0:00 and 5:59 hours Baseline, 6 months : - Change from baseline in preinjection plasma glucose - Change from baseline in variability of preinjection plasma glucose - Change from baseline in fasting plasma glucose (FPG) - Change from baseline in 8-point self-monitored plasma glucose profile - Change from baseline in daily basal insulin dose 6 months : - Percentage of patients with HbA1c < 7% at endpoint - Percentage of patients with FPG < 100mg/dL at endpoint Baseline, up to 6 months : - Change from baseline in treatment satisfaction score using the Diabetes Treatment Satisfaction Questionnaire (DTSQs) Up to 12 months : Number of Patients with various types of Hypoglycemia Events;Timepoint(s) of evaluation of this end point: Up to 6 months: Incidence of patients (%) with at least one nocturnal hypoglycemia between start of week 9 and endpoint, indicated as severe and/or confirmed by plasma glucose = 70 mg/dL (3.9 mmol/L) which occurred between 0:00 and 5:59 hours Baseline, 6 months: Change from baseline in preinjection plasma glucose, in variability of preinjection plasma glucose, in fasting plasma glucose (FPG), in 8-point self-monitored plasma glucose profile, in daily basal insulin dose 6 months: Percentage of patients with HbA1c < 7% at endpoint, with FPG <100mg/dL at endpoint Baseline, up to 6 months : Change from baseline in treatment satisfaction score using the Diabetes Treatment Satisfaction Questionnaire (DTSQs) Up to 12 months: Number of Patients with various types of Hypoglycemia Events	—

Measure

Time frame

Secondary end point(s): Up to 6 months : - Incidence of patients (%) with at least one nocturnal hypoglycemia between start of week 9 and endpoint, indicated as severe and/or confirmed by plasma glucose = 70 mg/dL (3.9 mmol/L) which occurred between 0:00 and 5:59 hours Baseline, 6 months : - Change from baseline in preinjection plasma glucose - Change from baseline in variability of preinjection plasma glucose - Change from baseline in fasting plasma glucose (FPG) - Change from baseline in 8-point self-monitored plasma glucose profile - Change from baseline in daily basal insulin dose 6 months : - Percentage of patients with HbA1c < 7% at endpoint - Percentage of patients with FPG < 100mg/dL at endpoint Baseline, up to 6 months : - Change from baseline in treatment satisfaction score using the Diabetes Treatment Satisfaction Questionnaire (DTSQs) Up to 12 months : Number of Patients with various types of Hypoglycemia Events;Timepoint(s) of evaluation of this end point: Up to 6 months: Incidence of patients (%) with at least one nocturnal hypoglycemia between start of week 9 and endpoint, indicated as severe and/or confirmed by plasma glucose = 70 mg/dL (3.9 mmol/L) which occurred between 0:00 and 5:59 hours Baseline, 6 months: Change from baseline in preinjection plasma glucose, in variability of preinjection plasma glucose, in fasting plasma glucose (FPG), in 8-point self-monitored plasma glucose profile, in daily basal insulin dose 6 months: Percentage of patients with HbA1c < 7% at endpoint, with FPG <100mg/dL at endpoint Baseline, up to 6 months : Change from baseline in treatment satisfaction score using the Diabetes Treatment Satisfaction Questionnaire (DTSQs) Up to 12 months: Number of Patients with various types of Hypoglycemia Events

—

Countries

Canada, Chile, Finland, Germany, Hungary, Mexico, Portugal, Russian Federation, South Africa, Spain, United States

Outcome results

None listed

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