Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications

Completed · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

Primary Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c). Secondary Objectives: To demonstrate the superiority of H0E901-U300 in comparison with Lantus in: * Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event from 22:00 to 08:59 next morning * Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dL \[3.9mmol/L\]) hypoglycemia event * Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event occurring at any time of day * HbA1c change

Key facts

Study ID

NCT02320721

Run by

Sanofi

People needed

1014

Starts

2015-01-01

Expected to finish

2016-05-01

Last updated by the study team

2020-04-21

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants ≥65 years old with type 2 diabetes mellitus, inadequately controlled on antidiabetic regimens either including no insulin, or with basal insulin as their only insulin.
• Signed informed consent.

You may not qualify if…

• HbA1c at screening visit:
• <7.0% or >10.0% for participants taking basal insulin.
• <7.5% or >11.0% for insulin-naïve participants.
• History of type 2 diabetes mellitus for less than 1 year before screening.
• Participants not on stable basal insulin dose (±10% in the last 8 weeks prior to screening visit).
• Change in dose of antidiabetic treatment or initiation of new glucose-lowering medications in the last 8 weeks prior to screening.
• Chronic (>10 days continuous use in previous 6 months) use of bolus insulin injections, whether given separately or as part of a combination with basal insulin, e.g. premix insulin; For insulin-naïve individuals: current or previous insulin use except for a maximum of 10 consecutive days (e.g. acute illness, surgery) during the last year prior to screening.
• Cognitive disorder and dementia assessed clinically and by Mini-Mental State Examination (MMSE) score <24, or any neurologic disorder that would likely affect the participant's ability to follow the study procedure. The participant would be eligible despite an MMSE score <24 if the investigator determined that the low score reflected educational or cultural background and not dementia as long as the participant was otherwise able to meet the study requirements.
• Participants who had end-stage renal disease (<15 mL/min/1.73m\^2, per estimated Glomerular filtration rate (eGFR) measurement by Modification of Diet in Renal Disease (MDRD).
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840019 — Fresno, California, United States
• Investigational Site Number 840021 — Fresno, California, United States
• Investigational Site Number 840040 — Greenbrae, California, United States
• Investigational Site Number 840070 — Huntington Park, California, United States
• Investigational Site Number 840064 — Los Angeles, California, United States
• Investigational Site Number 840031 — Norwalk, California, United States
• Investigational Site Number 840065 — Oakland, California, United States
• Investigational Site Number 840050 — Orange, California, United States
• Investigational Site Number 840036 — Simi Valley, California, United States
• Investigational Site Number 840003 — Temecula, California, United States
• Investigational Site Number 840062 — Walnut Creek, California, United States
• Investigational Site Number 840027 — Longmont, Colorado, United States
• Investigational Site Number 840030 — Bradenton, Florida, United States
• Investigational Site Number 840010 — Miami, Florida, United States
• Investigational Site Number 840035 — Miami, Florida, United States
• Investigational Site Number 840014 — New Port Richey, Florida, United States
• Investigational Site Number 840051 — Ocoee, Florida, United States
• Investigational Site Number 840056 — Palm Harbor, Florida, United States
• Investigational Site Number 840007 — St. Petersburg, Florida, United States
• Investigational Site Number 840041 — Roswell, Georgia, United States
• Investigational Site Number 840053 — Statesboro, Georgia, United States
• Investigational Site Number 840042 — Woodstock, Georgia, United States
• Investigational Site Number 840005 — Arlington Heights, Illinois, United States
• Investigational Site Number 840004 — Peoria, Illinois, United States
• Investigational Site Number 840058 — Saraland, Alabama, United States

Full record on ClinicalTrials.gov

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