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.

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 either including no insulin, or with basal insulin as their only insulin.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-078-14

Enrollment

Registered

2015-05-13

Start date

2015-07-05

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

HOE901-U300 (insulin glargine 300 units/mL solution) is supplied for subcutaneous (SC) administration as a sterile, non-pyrogenic, clear, colorless solution in a prefilled ie, disposable pen. Lantu

a dose equal to the former total daily dose for patients treated with a single daily injection of basal insulin

and a dose equal to 80% of the former total daily dose for patients formerly treated with more than one daily injection of NPH.

Eligibility

Sex/Gender

All

Age

65 Years to 100 Years

Inclusion criteria

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

Exclusion criteria: • HbA1c at screening visit: - 10.0% for patients taking basal insulin, - 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]).

Countries

Argentina, Australia, Brazil, Canada, Colombia, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Romania, Spain, Switzerland, United Kindgdom, United States

Contacts

Public ContactKatia Meza

SANOFI AVENTIS DEL PERU S.A.

katia.meza-ext@sanofi.com4114710 anexo 4765

Outcome results