Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy (EDITION III)

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

NCT01676220

2012-000146-35 (EudraCT Number)

U1111-1124-5261 (Other Identifier)

EFC12347

Details and patient eligibility

About

Primary 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 participants with type 2 diabetes mellitus

Secondary Objectives:

To compare a new formulation of insulin glargine and Lantus in terms of:

occurrence of nocturnal hypoglycemia

Full description

The maximum study duration was up to approximately 54 weeks per participant, consisting of:

Up to 2 week screening period; it can be exceptionally extended of up to one additional week
6-month comparative efficacy and safety treatment period
6-month comparative safety extension period
2-day post-treatment safety follow-up period

Enrollment

878 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

Adult participants with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s);
Signed written informed consent.

Exclusion criteria:

HbA1c less than (<) 7.0% (< 53 millimole per mole [mmol/mol]) or greater than (>) 11% (> 97 mmol/mol)
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 Glucagon-like peptide-1 (GLP-1) receptor agonist in the last 6 months before screening visit
Participants receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinide (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin, sulfonylurea and glinide are to be discontinued at baseline)
Current or previous insulin use except for a maximum of 8 consecutive days (for example, 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 (for example, laser, surgical treatment or injectable drugs) during the study period

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