Comparison of the Safety and Efficacy of HOE901-U300 with Lantus in Older Patients with Type 2 Diabetes Insufficiently Controlled on their Current Antidiabetic Medications
- Conditions
- Type 2 diabetes mellitusMedDRA version: 17.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2014-002399-10-SE
- Lead Sponsor
- Sanofi-aventis recherche & développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 920
Patients =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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 920
HbA1c at screening visit:
- <7.0% or >10.0% for patients taking basal insulin.
- <7.5% or >11.0% for insulin-naïve patients.
History of type 2 diabetes mellitus for less than 1 year before screening.
Patients 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, eg, 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 will likely affect the patient’s ability to follow the study procedure. The patient will be eligible despite an MMSE score <24 if the investigator determines that the low score reflects educational or cultural background and not dementia as long as the patient is otherwise able to meet the study requirements.
Patients who have 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]).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c);Secondary Objective: To demonstrate the superiority of H0E901-U300 in comparison with Lantus in:<br>- Percentage of patients 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 <br>- Percentage of patients with at least one nocturnal (from 00:00–05:59) severe and/or confirmed (=70mg/dL [3.9mmol/L]) hypoglycemia event<br>- Percentage of patients with at least one severe and/or confirmed (by plasma glucose =70mg/dL [3.9mmol/L]) hypoglycemia event occurring at any time of day<br>- HbA1c change;Primary end point(s): Change in HbA1c from baseline;Timepoint(s) of evaluation of this end point: baseline, week 26
- Secondary Outcome Measures
Name Time Method