NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: Insulin Glargine (HOE901 - U300), Insulin Glargine (HOE901 - U100), Background therapy
Countries: United States, Argentina, Australia, Canada, Colombia, France, Germany, Hungary
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
Sex: ALL
Age: 65 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion criteria: * 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. Exclusion criteria: * 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.
- Saraland, Alabama, United States
- Fresno, California, United States
- Fresno, California, United States
- Greenbrae, California, United States
- Huntington Park, California, United States
- Los Angeles, California, United States
- Norwalk, California, United States
- Oakland, California, United States
- Orange, California, United States
- Simi Valley, California, United States
- Temecula, California, United States
- Walnut Creek, California, United States
- Longmont, Colorado, United States
- Bradenton, Florida, United States
- Miami, Florida, United States
- Miami, Florida, United States
- New Port Richey, Florida, United States
- Ocoee, Florida, United States
- Palm Harbor, Florida, United States
- St. Petersburg, Florida, United States
- Roswell, Georgia, United States
- Statesboro, Georgia, United States
- Woodstock, Georgia, United States
- Arlington Heights, Illinois, United States
- Peoria, Illinois, United States
- Springfield, Illinois, United States
- Avon, Indiana, United States
- Avon, Indiana, United States
- Evansville, Indiana, United States
- Muncie, Indiana, United States
- + 132 more on CT.gov