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

Completed · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT01676220

Run by

Sanofi

People needed

878

Starts

2012-08-01

Expected to finish

2014-03-01

Last updated by the study team

2015-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840273 — Chandler, Arizona, United States
• Investigational Site Number 840217 — Mesa, Arizona, United States
• Investigational Site Number 840220 — Peoria, Arizona, United States
• Investigational Site Number 840211 — Phoenix, Arizona, United States
• Investigational Site Number 840207 — Phoenix, Arizona, United States
• Investigational Site Number 840264 — Tempe, Arizona, United States
• Investigational Site Number 840234 — Tempe, Arizona, United States
• Investigational Site Number 840304 — Little Rock, Arkansas, United States
• Investigational Site Number 840347 — Bell Gardens, California, United States
• Investigational Site Number 840244 — Escondido, California, United States
• Investigational Site Number 840257 — Fresno, California, United States
• Investigational Site Number 840213 — Greenbrae, California, United States
• Investigational Site Number 840267 — Huntington Beach, California, United States
• Investigational Site Number 840230 — La Jolla, California, United States
• Investigational Site Number 840235 — La Mesa, California, United States
• Investigational Site Number 840274 — La Mesa, California, United States
• Investigational Site Number 840222 — Long Beach, California, United States
• Investigational Site Number 840243 — Palm Springs, California, United States
• Investigational Site Number 840250 — Spring Valley, California, United States
• Investigational Site Number 840209 — Temecula, California, United States
• Investigational Site Number 840297 — Torrance, California, United States
• Investigational Site Number 840272 — Tustin, California, United States
• Investigational Site Number 840223 — Walnut Creek, California, United States
• Investigational Site Number 840249 — Colorado Springs, Colorado, United States
• Investigational Site Number 840324 — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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