Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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21 December 2021 |
Main ID: |
EUCTR2014-002399-10-HU |
Date of registration:
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26/11/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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:
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23/12/2014 |
Target sample size:
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920 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002399-10 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Brazil
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Canada
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Colombia
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France
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Germany
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Hungary
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Italy
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Japan
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Korea, Republic of
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Mexico
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Peru
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Poland
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Romania
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Spain
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Sweden
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United Kingdom
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Contacts
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Name:
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NA.
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Address:
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Tó u. 1-5.
1045
Budapest
Hungary |
Telephone:
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Email:
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kapcsolat@sanofi.com |
Affiliation:
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sanofi-aventis Zrt. |
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Name:
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NA.
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Address:
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Tó u. 1-5.
1045
Budapest
Hungary |
Telephone:
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Email:
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kapcsolat@sanofi.com |
Affiliation:
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sanofi-aventis Zrt. |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
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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
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Intervention(s)
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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-
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Primary Outcome(s)
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Main Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c)
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Primary end point(s): Change in HbA1c from baseline
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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
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Timepoint(s) of evaluation of this end point: baseline, week 26
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Secondary Outcome(s)
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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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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
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Secondary ID(s)
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2014-002399-10-SE
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EFC13799
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Source(s) of Monetary Support
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Sanofi-aventis recherche & développement
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Ethics review
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Status: Approved
Approval date: 16/12/2014
Contact:
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