A RANDOMIZED, OPEN-LABEL, 2-ARM PARALLEL-GROUP, MULTICENTER, 26-WEEK STUDY ASSESSING THE SAFETY AND EFFICACY OF HOE901-U300 VERSUS LANTUS IN OLDER PATIENTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED ON ANTIDIABETIC REGIMENS.

Not Applicable

• Conditions: -E14 Unspecified diabetes mellitus; Unspecified diabetes mellitus; E14

• Registration Number: PER-078-14
• Lead Sponsor: Sanofi Aventis Recherche & Development,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-13
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

- Patients ≥ 65 years old with type 2 diabetes mellitus, inadequately controlled on pharmacologic antidiabetic regimens either including no insulin, or with basal insulin as their only insulin; and
- Signed informed consent

Exclusion Criteria

• HbA1c at screening visit:
- < 7.0% or > 10.0% for patients taking basal insulin,
- < 7.5% or > 11.0% for insulin-naïve patients.
• Patients not on stable basal insulin dose (±10% in the last 8 weeks prior to screening visit); Change in dose of non-insulin 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.
• 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.
• Patients who have end-stage renal disease (<15 mL/min/1.73m2, per estimated Glomerular filtration rate (eGFR) measurement by Modification of Diet in Renal Disease [MDRD]).

Study & Design

• Study Type: Interventional
• Study Design: Not specified