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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
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
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
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
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
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
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
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
Timepoint [7] 0 0
Baseline, Week 26
Secondary outcome [8] 0 0
Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment
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
Sex
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
1/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
Accrual to date
Final
1014
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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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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02320721