Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin (EDITION I)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Lantus (insulin glargine); Drug: HOE901-U300 (new formulation of insulin glargine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01499082

EFC11628

2010-023769-23 (EudraCT Number)

Details and patient eligibility

About

Primary Objective:

• To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus

Secondary Objectives:

• To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia

Full description

The maximum study duration was up to approximately 58 weeks per participant, consisting of:

• up to 2 week screening period
• 6-month comparative efficacy and safety treatment period
• 6-month comparative safety extension period
• 4-week safety follow-up period in a subset of participants
• a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300

Enrollment: 807 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

• Participants with type 2 diabetes mellitus

• Substudy inclusion criteria:

  • Completion of the 6-month study period in main study (Visit 10)
  • Randomized and treated with insulin glargine new formulation during the 6-month treatment period (Baseline - month 6)

Exclusion criteria:

• Age less than (<) 18 years

• HbA1c <7.0% or greater than (>) 10% at screening

• Diabetes other than type 2 diabetes mellitus

• Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose

• Any contraindication to use of insulin glargine as defined in the national product label

• Participants using human regular insulin as mealtime insulin in the last 3 months before screening visit

• Use of an insulin pump in the last 6 months before screening visit

• Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before screening visit

• History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period

• Pregnant or breast-feeding women or women who intend to become pregnant during the study period

• Substudy exclusion criteria:

  • Participant not willing to use the adaptable injection intervals on at least two days per week

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

807 participants in 2 patient groups

HOE901-U300

Experimental group

Treatment:

Drug: HOE901-U300 (new formulation of insulin glargine)

Lantus

Active Comparator group

Treatment:

Drug: Lantus (insulin glargine)