Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin

Completed · Phase 2

Conditions studied: Type 1 Diabetes Mellitus

In brief

Primary Objective: * To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus Secondary Objectives: * To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening * To compare the incidence and frequency of hypoglycemic episodes * To assess the safety and tolerability of the new formulation of insulin glargine

Key facts

Study ID

NCT01658579

Run by

Sanofi

People needed

59

Starts

2012-08-01

Expected to finish

2013-05-01

Last updated by the study team

2015-06-01

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with Type 1 diabetes mellitus

You may not qualify if…

• HbA1c greater than (>) 9% (at screening)
• Participants receiving >0.5 U/kg body weight basal insulin in the last 30 days prior to screening visit
• Participants not on stable insulin dose (+/- 20% total basal insulin dose) in the last 30 days prior to screening visit
• Less than 1 year on any basal plus mealtime insulin
• Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any antidiabetic drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit
• Use of an insulin pump in the last 6 months before screening visit;
• Any contraindication to use of insulin glargine as defined in the national product label
• Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening
• Hospitalization for diabetic ketoacidosis or history of severe hypoglycemia (requiring 3rd party assistance) in the last 6 months prior to randomization
• Initiation of any glucose-lowering agents in the last 3 months before screening visit
• Weight change of greater than equal to (>=) 5 kg during the last 3 months prior to screening visit
• Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require 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 840002 — Temecula, California, United States
• Investigational Site Number 840001 — Minneapolis, Minnesota, United States
• Investigational Site Number 840003 — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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