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

• Register: EUCTR
• Last refreshed on: 24 July 2017
• Main ID: EUCTR2014-002399-10-SE
• Date of registration: 18/11/2014
• Prospective Registration: Yes
• Primary sponsor: Sanofi-aventis recherche & développement
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 08/01/2015
• Target sample size: 920
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002399-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Country Team Manager Sweden
• Affiliation: Sanofi AB

• Name: Country Team Manager Sweden
• Affiliation: Sanofi AB

Key inclusion & exclusion 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:
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]).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

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

Intervention(s)

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: HOE901 - U300
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 300-

Trade Name: Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337-95-1
Current Sponsor code: HOE901
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): Change in HbA1c from baseline

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

Timepoint(s) of evaluation of this end point: baseline, week 26

Main Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1 - 2 - 3 - 4 - 5 - 8 - week 26

6 - 7 - baseline, week 26

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

Secondary ID(s)

EFC13799

Source(s) of Monetary Support

Sanofi-aventis recherche & développement