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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02320721
Registration number
NCT02320721
Ethics application status
Date submitted
16/12/2014
Date registered
19/12/2014
Date last updated
21/04/2020
Titles & IDs
Public title
Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications
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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
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Secondary ID [1]
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2014-002399-10
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Secondary ID [2]
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EFC13799
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Universal Trial Number (UTN)
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Trial acronym
SENIOR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Insulin Glargine (HOE901 - U300)
Treatment: Drugs - Insulin Glargine (HOE901 - U100)
Treatment: Drugs - Background therapy
Experimental: HOE901-U300 - HOE901-U300 (Insulin glargine, 300 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Active comparator: Lantus - Lantus (Insulin glargine, 100 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
Treatment: Drugs: Insulin Glargine (HOE901 - U300)
Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).
Treatment: Drugs: Insulin Glargine (HOE901 - U100)
Self-administered by SC injection in the evening using a pre-filled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).
Treatment: Drugs: Background therapy
Non-insulin anti-diabetic drugs with the exception of thiazolidinediones.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in HbA1c From Baseline to Week 26
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Assessment method [1]
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Adjusted least square (LS) means were obtained from analysis of covariance (ANCOVA) after multiple imputation of missing data including post baseline HbA1c data during the 26-week randomized period.
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Timepoint [1]
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Baseline, Week 26
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Secondary outcome [1]
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Percentage of Participants With At Least One Severe and/ or Confirmed (=3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (22:00 to 08:59 Hours Next Morning) During 26-Week Randomized Period
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Assessment method [1]
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Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose =3.9 mmol/L (70 mg/dL).
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Timepoint [1]
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Baseline up to Week 26
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Secondary outcome [2]
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Percentage of Participants With At Least One Severe and/ or Confirmed (=3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (00:00 to 05:59 Hours) During 26-Week Randomized Period
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Assessment method [2]
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Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose =3.9 mmol/L (70 mg/dL).
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Timepoint [2]
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Baseline up to Week 26
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Secondary outcome [3]
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Percentage of Participants With At Least One Severe and/ or Confirmed (=3.9 mmol/L [70 mg/dL]) Hypoglycemia Occurring at Any Time of the Day During 26-Week Randomized Period
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Assessment method [3]
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Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose =3.9 mmol/L (70 mg/dL).
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Timepoint [3]
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Baseline up to Week 26
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Secondary outcome [4]
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Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period
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Assessment method [4]
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Participants without any available HbA1c assessment at Week 26 were considered as non-responders in the analyses.
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Timepoint [4]
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Baseline up to Week 26
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Secondary outcome [5]
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Percentage of Participants With HbA1c <7.5% or <7.0% at Week 26 and No Severe and/or Confirmed (=3.9 mmol/L [70 mg/dL]) Hypoglycemia During 26-Week Randomized Period
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Assessment method [5]
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Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose =3.9 mmol/L (70 mg/dL).
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Timepoint [5]
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Baseline up to Week 26
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Secondary outcome [6]
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Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
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Assessment method [6]
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Adjusted LS means from multiple imputation approach including post baseline values during the 26-week randomized period.
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Timepoint [6]
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Baseline, Week 26
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Secondary outcome [7]
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Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26
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Assessment method [7]
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WHO-5 well-being index evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions, each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score was transformed into a percentage score ranging from 0 (worst possible quality of life) to 100 (best possible quality of life).
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Timepoint [7]
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Baseline, Week 26
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Secondary outcome [8]
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Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment
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Assessment method [8]
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Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after Week 14) values were used to determine the requirement of rescue medication. Threshold values at Week 14: FPG \>200 mg/dL (11 mmol/L), or HbA1c \>8.5%.
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Timepoint [8]
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Baseline up to Week 26
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Eligibility
Key inclusion criteria
Inclusion criteria:
* Participants =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.
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
* HbA1c at screening visit:
* <7.0% or >10.0% for participants taking basal insulin.
* <7.5% or >11.0% for insulin-naïve participants.
* History of type 2 diabetes mellitus for less than 1 year before screening.
* Participants 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, e.g. 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 would likely affect the participant's ability to follow the study procedure. The participant would be eligible despite an MMSE score <24 if the investigator determined that the low score reflected educational or cultural background and not dementia as long as the participant was otherwise able to meet the study requirements.
* Participants who had 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).
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2016
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Sample size
Target
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Accrual to date
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Final
1014
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site Number 036002 - Box Hill
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Investigational Site Number 036004 - Fitzroy
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Investigational Site Number 036001 - Geelong
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Recruitment hospital [4]
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Investigational Site Number 036003 - Herston
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3128 - Box Hill
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3065 - Fitzroy
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3220 - Geelong
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4029 - Herston
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Recruitment outside Australia
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Funding & Sponsors
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Name
Sanofi
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Ethics approval
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Summary
Brief summary
Primary Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c). Secondary Objectives: To demonstrate the superiority of H0E901-U300 in comparison with Lantus in: * Percentage of participants 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 participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (=70mg/dL \[3.9mmol/L\]) hypoglycemia event * Percentage of participants 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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Trial website
https://clinicaltrials.gov/study/NCT02320721
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Trial related presentations / publications
Ritzel R, Harris SB, Baron H, Florez H, Roussel R, Espinasse M, Muehlen-Bartmer I, Zhang N, Bertolini M, Brulle-Wohlhueter C, Munshi M, Bolli GB. A Randomized Controlled Trial Comparing Efficacy and Safety of Insulin Glargine 300 Units/mL Versus 100 Units/mL in Older People With Type 2 Diabetes: Results From the SENIOR Study. Diabetes Care. 2018 Aug;41(8):1672-1680. doi: 10.2337/dc18-0168. Epub 2018 Jun 12. Erratum In: Diabetes Care. 2019 Aug;42(8):1604. doi: 10.2337/dc19-er08.
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Public notes
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Contacts
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Clinical Sciences & Operations
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Sanofi
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Journal
Ritzel R, Harris SB, Baron H, Florez H, Roussel R,...
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https://clinicaltrials.gov/study/NCT02320721
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