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

NCT01499082

CompletedPhase 3

Sponsor: Sanofi

Conditions: Type 2 Diabetes Mellitus

Interventions: HOE901-U300 (new formulation of insulin glargine), Lantus (insulin glargine)

Countries: United States, Canada, Czechia, Estonia, Finland, France, Germany, Hungary

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (193)

Chandler, Arizona, United States
Glendale, Arizona, United States
Phoenix, Arizona, United States
Sun City, Arizona, United States
Tempe, Arizona, United States
Hot Springs, Arkansas, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Searcy, Arkansas, United States
Anaheim, California, United States
Encino, California, United States
Greenbrae, California, United States
Huntington Beach, California, United States
La Jolla, California, United States
La Mesa, California, United States
Mission Hills, California, United States
Palm Springs, California, United States
San Diego, California, United States
Tustin, California, United States
Walnut Creek, California, United States
Colorado Springs, Colorado, United States
Colorado Springs, Colorado, United States
Longmont, Colorado, United States
Daytona Beach, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
New Port Richey, Florida, United States
Ocoee, Florida, United States
+ 163 more on CT.gov