Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy

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 Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus Secondary Objective: * To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal hypoglycemia

Key facts

Study ID

NCT01499095

Run by

Sanofi

People needed

811

Starts

2011-12-01

Expected to finish

2013-11-01

Last updated by the study team

2022-03-23

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 6 months on basal insulin treatment together with oral antihyperglycemic drug(s) and self-monitoring of blood glucose
• Participants using sulfonylurea in the last 2 months before screening visit
• Any contraindication to use of insulin glargine as defined in the national product label
• Use of insulin pump in the last 6 months before screening
• Initiation of new glucose-lowering medications 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 840149 — Chandler, Arizona, United States
• Investigational Site Number 840093 — Glendale, Arizona, United States
• Investigational Site Number 840069 — Phoenix, Arizona, United States
• Investigational Site Number 840110 — Sun City, Arizona, United States
• Investigational Site Number 840068 — Tempe, Arizona, United States
• Investigational Site Number 840015 — Hot Springs, Arkansas, United States
• Investigational Site Number 840014 — Little Rock, Arkansas, United States
• Investigational Site Number 840114 — Little Rock, Arkansas, United States
• Investigational Site Number 840018 — Mountain Home, Arkansas, United States
• Investigational Site Number 840027 — Searcy, Arkansas, United States
• Investigational Site Number 840074 — Anaheim, California, United States
• Investigational Site Number 840509 — Bell Gardens, California, United States
• Investigational Site Number 840060 — Greenbrae, California, United States
• Investigational Site Number 840057 — La Jolla, California, United States
• Investigational Site Number 840003 — La Mesa, California, United States
• Investigational Site Number 840026 — Los Angeles, California, United States
• Investigational Site Number 840090 — Mission Hills, California, United States
• Investigational Site Number 840099 — Palm Springs, California, United States
• Investigational Site Number 840004 — San Diego, California, United States
• Investigational Site Number 840124 — Santa Barbara, California, United States
• Investigational Site Number 840012 — Tustin, California, United States
• Investigational Site Number 840104 — Colorado Springs, Colorado, United States
• Investigational Site Number 840128 — Colorado Springs, Colorado, United States
• Investigational Site Number 840098 — Denver, Colorado, United States
• Investigational Site Number 840517 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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