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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
2014-002399-10
Secondary ID [2] 0 0
EFC13799
Universal Trial Number (UTN)
Trial acronym
SENIOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c From Baseline to Week 26 - 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.
Timepoint [1] 0 0
Baseline, Week 26
Secondary outcome [1] 0 0
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 - 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).
Timepoint [1] 0 0
Baseline up to Week 26
Secondary outcome [2] 0 0
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 - 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).
Timepoint [2] 0 0
Baseline up to Week 26
Secondary outcome [3] 0 0
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 - 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).
Timepoint [3] 0 0
Baseline up to Week 26
Secondary outcome [4] 0 0
Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period - Participants without any available HbA1c assessment at Week 26 were considered as non-responders in the analyses.
Timepoint [4] 0 0
Baseline up to Week 26
Secondary outcome [5] 0 0
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 - 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).
Timepoint [5] 0 0
Baseline up to Week 26
Secondary outcome [6] 0 0
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 - Adjusted LS means from multiple imputation approach including post baseline values during the 26-week randomized period.
Timepoint [6] 0 0
Baseline, Week 26
Secondary outcome [7] 0 0
Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26 - 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).
Timepoint [7] 0 0
Baseline, Week 26
Secondary outcome [8] 0 0
Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment - 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%.
Timepoint [8] 0 0
Baseline up to Week 26

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.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036002 - Box Hill
Recruitment hospital [2] 0 0
Investigational Site Number 036004 - Fitzroy
Recruitment hospital [3] 0 0
Investigational Site Number 036001 - Geelong
Recruitment hospital [4] 0 0
Investigational Site Number 036003 - Herston
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment outside Australia
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Alabama
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Caba
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Capital Federal
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Argentina
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Ciudad Autonoma De Buenos Aire
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Mar Del Plata
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Montreal
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Sevilla
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Göteborg
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Härnösand
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Rättvik
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Sweden
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Västra Frölunda
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United Kingdom
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Belfast
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Bristol
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United Kingdom
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Redhill
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Rotherham
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United Kingdom
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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/show/NCT02320721
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications