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

Completed · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT01499082

Run by

Sanofi

People needed

807

Starts

2011-12-01

Expected to finish

2013-09-01

Last updated by the study team

2022-03-25

Who can join

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

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840102 — Glendale, Arizona, United States
• Investigational Site Number 840071 — Phoenix, Arizona, United States
• Investigational Site Number 840121 — Sun City, Arizona, United States
• Investigational Site Number 840070 — Tempe, Arizona, United States
• Investigational Site Number 840016 — Hot Springs, Arkansas, United States
• Investigational Site Number 840015 — Little Rock, Arkansas, United States
• Investigational Site Number 840124 — Little Rock, Arkansas, United States
• Investigational Site Number 840032 — Searcy, Arkansas, United States
• Investigational Site Number 840076 — Anaheim, California, United States
• Investigational Site Number 840133 — Encino, California, United States
• Investigational Site Number 840062 — Greenbrae, California, United States
• Investigational Site Number 840057 — Huntington Beach, California, United States
• Investigational Site Number 840059 — La Jolla, California, United States
• Investigational Site Number 840004 — La Mesa, California, United States
• Investigational Site Number 840099 — Mission Hills, California, United States
• Investigational Site Number 840107 — Palm Springs, California, United States
• Investigational Site Number 840005 — San Diego, California, United States
• Investigational Site Number 840013 — Tustin, California, United States
• Investigational Site Number 840002 — Walnut Creek, California, United States
• Investigational Site Number 840114 — Colorado Springs, Colorado, United States
• Investigational Site Number 840136 — Colorado Springs, Colorado, United States
• Investigational Site Number 840092 — Longmont, Colorado, United States
• Investigational Site Number 840049 — Daytona Beach, Florida, United States
• Investigational Site Number 840050 — Hollywood, Florida, United States
• Investigational Site Number 840156 — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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