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Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications (SENIOR)

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ClinicalTrials.gov Identifier: NCT02320721
Recruitment Status : Completed
First Posted : December 19, 2014
Results First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE December 16, 2014
First Posted Date  ICMJE December 19, 2014
Results First Submitted Date  ICMJE May 18, 2017
Results First Posted Date  ICMJE July 11, 2017
Last Update Posted Date July 11, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2017)
Change in HbA1c From Baseline to Week 26 [ Time Frame: Baseline, 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2014)
Change in HbA1c from baseline [ Time Frame: Baseline, Week 26 ]
Change History Complete list of historical versions of study NCT02320721 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2017)
  • 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 [ Time Frame: Baseline up to Week 26 ]
    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).
  • 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 [ Time Frame: Baseline up to Week 26 ]
    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).
  • 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 [ Time Frame: Baseline up to Week 26 ]
    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).
  • Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period [ Time Frame: Baseline up to Week 26 ]
    Participants without any available HbA1c assessment at Week 26 were considered as non-responders in the analyses.
  • 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 [ Time Frame: Baseline up to Week 26 ]
    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).
  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]
    Adjusted LS means from multiple imputation approach including post baseline values during the 26-week randomized period.
  • Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26 [ Time Frame: Baseline, 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).
  • Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment [ Time Frame: Baseline up to Week 26 ]
    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%.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2014)
  • 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 [ Time Frame: week 26 ]
  • 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 [ Time Frame: week 26 ]
  • 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 [ Time Frame: week 26 ]
  • Percentage of patients with HbA1c (a) <7.5% (b), <7.0%, at Week 26 [ Time Frame: week 26 ]
  • 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 [ Time Frame: week 26 ]
  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]
  • Change in Patient Report Outmcome (PRO) instruments scores from baseline to Week 26 [ Time Frame: Baseline, Week 26 ]
  • Percentage of patients requiring rescue therapy over the 26 weeks of treatment [ Time Frame: week 26 ]
Current Other Pre-specified Outcome Measures
 (submitted: June 12, 2017)
  • Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment [ Time Frame: Baseline up to Week 26 ]
    Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).
  • Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year During the 26 Weeks of Treatment [ Time Frame: Baseline up to Week 26 ]
    Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications
Official Title  ICMJE 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
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
Detailed Description The study consisted of a 4-week screening period, a 26-week treatment period comparing HOE901-U300 to Lantus, and a 2-day safety follow-up period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: 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).
    Other Name: Toujeo®
  • Drug: 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).
    Other Name: Lantus®
  • Drug: Background therapy
    Non-insulin anti-diabetic drugs with the exception of thiazolidinediones.
Study Arms  ICMJE
  • Experimental: HOE901-U300
    HOE901-U300 (Insulin glargine, 300 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
    Interventions:
    • Drug: Insulin Glargine (HOE901 - U300)
    • Drug: Background therapy
  • Active Comparator: Lantus
    Lantus (Insulin glargine, 100 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
    Interventions:
    • Drug: Insulin Glargine (HOE901 - U100)
    • Drug: Background therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2016)
1014
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2014)
920
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Canada,   Colombia,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Mexico,   Peru,   Poland,   Romania,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02320721
Other Study ID Numbers  ICMJE EFC13799
2014-002399-10
U1111-1159-3018 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP