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

A Randomized, Open-label, 2-arm Parallel-group, Multicenter, 26-week Study Assessing the Safety and Efficacy of H0E901-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 - SENIOR

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002399-10-SE

Enrollment

920

Registered

2014-11-18

Start date

2015-01-08

Completion date

Unknown

Last updated

2017-07-24

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

Conditions

Type 2 diabetes mellitus MedDRA version: 17.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: HOE901 - U300 Product Code: HOE901 - U300 Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: INSULIN GLARGINE CAS Number: 160337-95-1 Current Sponsor code

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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: - 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 - Percentage of patients with at least one nocturnal (from 00:00–05:59) severe and/or confirmed (=70mg/dL [3.9mmol/L]) hypoglycemia event - 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 - HbA1c change;Primary end point(s): Change in HbA1c from baseline;Timepoint(s) of evaluation of this end point: baseline, week 26	—

Measure

Time frame

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: - 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 - Percentage of patients with at least one nocturnal (from 00:00–05:59) severe and/or confirmed (=70mg/dL [3.9mmol/L]) hypoglycemia event - 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 - HbA1c change;Primary end point(s): Change in HbA1c from baseline;Timepoint(s) of evaluation of this end point: baseline, week 26

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Secondary

Measure	Time frame
Secondary end point(s): 1 - Incidence (% of patients) of severe and/or confirmed (by plasma glucose =70mg/dL [3.9mmol/L]) hypoglycemia event (symptomatic or asymptomatic) from 22:00 to 08:59 next morning over 26 weeks of treatment 2 - Incidence (% of patients) of nocturnal (from 00:00 to 05:59) severe and/or confirmed (=70 mg/dL [3.9mmol/L]) hypoglycemia (symptomatic or asymptomatic) over 26 weeks of treatment 3 - Incidence (% of patients) of severe and/or confirmed (by plasma glucose =70mg/dL [3.9mmol/L]) hypoglycemia (symptomatic or asymptomatic), occurring at any time of day, over 26 weeks of treatment 4 - Percentage of patients with HbA1c (a) <7.5% (b), <7.0%, at Week 26 5 - Percentage of eligible patients with HbA1c (a) <7.5%, (b) <7.0%, at Week 26, with no severe and/or confirmed (by plasma glucose =70mg/dL [3.9mmol/L]) hypoglycemia event over 26 weeks of treatment 6 - Change in fasting plasma glucose (FPG) from baseline to Week 26 7 - Change in Patient Report Outmcome (PRO) instruments scores from baseline to Week 26 8 - Percentage of patients requiring rescue therapy over the 26 weeks of treatment;Timepoint(s) of evaluation of this end point: 1 - 2 - 3 - 4 - 5 - 8 - week 26 6 - 7 - baseline, week 26	—

Measure

Time frame

Secondary end point(s): 1 - Incidence (% of patients) of severe and/or confirmed (by plasma glucose =70mg/dL [3.9mmol/L]) hypoglycemia event (symptomatic or asymptomatic) from 22:00 to 08:59 next morning over 26 weeks of treatment 2 - Incidence (% of patients) of nocturnal (from 00:00 to 05:59) severe and/or confirmed (=70 mg/dL [3.9mmol/L]) hypoglycemia (symptomatic or asymptomatic) over 26 weeks of treatment 3 - Incidence (% of patients) of severe and/or confirmed (by plasma glucose =70mg/dL [3.9mmol/L]) hypoglycemia (symptomatic or asymptomatic), occurring at any time of day, over 26 weeks of treatment 4 - Percentage of patients with HbA1c (a) <7.5% (b), <7.0%, at Week 26 5 - Percentage of eligible patients with HbA1c (a) <7.5%, (b) <7.0%, at Week 26, with no severe and/or confirmed (by plasma glucose =70mg/dL [3.9mmol/L]) hypoglycemia event over 26 weeks of treatment 6 - Change in fasting plasma glucose (FPG) from baseline to Week 26 7 - Change in Patient Report Outmcome (PRO) instruments scores from baseline to Week 26 8 - Percentage of patients requiring rescue therapy over the 26 weeks of treatment;Timepoint(s) of evaluation of this end point: 1 - 2 - 3 - 4 - 5 - 8 - week 26 6 - 7 - baseline, week 26

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Countries

Argentina, Australia, Brazil, Canada, Colombia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Peru, Poland, Romania, Spain, Sweden, United Kingdom

Contacts

Public ContactCountry Team Manager Sweden

Sanofi AB

clinicaltrials.sweden@sanofi.com+46 8 634 5000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026