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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Insulin Glargine (HOE901 - U300) Drug: Insulin Glargine (HOE901 - U100) Drug: Background therapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1014 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HOE901-U300
HOE901-U300 (Insulin glargine, 300 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
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: Background therapy
Non-insulin anti-diabetic drugs with the exception of thiazolidinediones.

Active Comparator: Lantus
Lantus (Insulin glargine, 100 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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).

  6. 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.

  7. 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).

  8. 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%.


Other Outcome Measures:
  1. 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).

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320721


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Locations
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United States, Alabama
Investigational Site Number 840058
Saraland, Alabama, United States, 36571
United States, California
Investigational Site Number 840019
Fresno, California, United States, 93720
Investigational Site Number 840021
Fresno, California, United States, 93722
Investigational Site Number 840040
Greenbrae, California, United States, 94904
Investigational Site Number 840070
Huntington Park, California, United States, 90255
Investigational Site Number 840064
Los Angeles, California, United States, 90057
Investigational Site Number 840031
Norwalk, California, United States, 90650
Investigational Site Number 840065
Oakland, California, United States, 94612
Investigational Site Number 840050
Orange, California, United States, 92868
Investigational Site Number 840036
Simi Valley, California, United States, 93065
Investigational Site Number 840003
Temecula, California, United States, 92591
Investigational Site Number 840062
Walnut Creek, California, United States, 94598
United States, Colorado
Investigational Site Number 840027
Longmont, Colorado, United States, 80501
United States, Florida
Investigational Site Number 840030
Bradenton, Florida, United States, 34208
Investigational Site Number 840010
Miami, Florida, United States, 33156
Investigational Site Number 840035
Miami, Florida, United States, 33156
Investigational Site Number 840014
New Port Richey, Florida, United States, 34652
Investigational Site Number 840051
Ocoee, Florida, United States, 34761
Investigational Site Number 840056
Palm Harbor, Florida, United States, 34684
Investigational Site Number 840007
Saint Petersburg, Florida, United States
United States, Georgia
Investigational Site Number 840041
Roswell, Georgia, United States, 30076
Investigational Site Number 840053
Statesboro, Georgia, United States, 30461
Investigational Site Number 840042
Woodstock, Georgia, United States, 30189
United States, Illinois
Investigational Site Number 840005
Arlington Heights, Illinois, United States, 60005
Investigational Site Number 840004
Peoria, Illinois, United States, 61602
Investigational Site Number 840029
Springfield, Illinois, United States, 62704
United States, Indiana
Investigational Site Number 840013
Avon, Indiana, United States, 46123
Investigational Site Number 840023
Avon, Indiana, United States, 46123
Investigational Site Number 840039
Evansville, Indiana, United States, 47714
Investigational Site Number 840006
Muncie, Indiana, United States, 47304
United States, Iowa
Investigational Site Number 840026
Des Moines, Iowa, United States, 50314
Investigational Site Number 840033
West Des Moines, Iowa, United States, 50266
United States, Kansas
Investigational Site Number 840032
Overland Park, Kansas, United States, 66209
United States, Louisiana
Investigational Site Number 840069
Metairie, Louisiana, United States, 70006
United States, Michigan
Investigational Site Number 840020
Flint, Michigan, United States, 48504
United States, New Hampshire
Investigational Site Number 840037
Nashua, New Hampshire, United States, 03063
United States, New York
Investigational Site Number 840018
New York, New York, United States, 10001
United States, North Carolina
Investigational Site Number 840048
Asheville, North Carolina, United States, 28805
Investigational Site Number 840009
Charlotte, North Carolina, United States, 28209
Investigational Site Number 840011
Greensboro, North Carolina, United States, 27408
Investigational Site Number 840047
Greenville, North Carolina, United States, 27834
Investigational Site Number 840016
Salisbury, North Carolina, United States, 28144
Investigational Site Number 840012
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Investigational Site Number 840022
Fargo, North Dakota, United States, 58103
United States, Ohio
Investigational Site Number 840072
Cincinnati, Ohio, United States, 45219
Investigational Site Number 840054
Wadsworth, Ohio, United States, 44281
United States, Oregon
Investigational Site Number 840067
Bend, Oregon, United States, 97702
Investigational Site Number 840057
Corvallis, Oregon, United States, 97330
United States, Pennsylvania
Investigational Site Number 840045
Feasterville, Pennsylvania, United States, 19053
Investigational Site Number 840017
Pittsburgh, Pennsylvania, United States, 15220
United States, South Carolina
Investigational Site Number 840059
Greenville, South Carolina, United States, 29605
Investigational Site Number 840015
Greer, South Carolina, United States, 29651
United States, Tennessee
Investigational Site Number 840002
Chattanooga, Tennessee, United States, 37404
Investigational Site Number 840046
Chattanooga, Tennessee, United States, 37404
Investigational Site Number 840034
Knoxville, Tennessee, United States, 37912
United States, Texas
Investigational Site Number 840055
Arlington, Texas, United States, 76014
Investigational Site Number 840001
Dallas, Texas, United States, 75230
Investigational Site Number 840024
Irving, Texas, United States, 75039
Investigational Site Number 840061
North Richland Hills, Texas, United States, 76180
Investigational Site Number 840028
Richmond, Texas, United States, 77469
Investigational Site Number 840063
San Antonio, Texas, United States, 78230
United States, Utah
Investigational Site Number 840038
Saint George, Utah, United States, 84790
United States, Washington
Investigational Site Number 840025
Federal Way, Washington, United States, 98003
United States, West Virginia
Investigational Site Number 840060
Bridgeport, West Virginia, United States, 26330
Argentina
Investigational Site Number 032001
Caba, Argentina, 1120
Investigational Site Number 032002
Caba, Argentina, 1405
Investigational Site Number 032006
Capital Federal, Argentina, 1180
Investigational Site Number 032004
Ciudad Autonoma De Buenos Aire, Argentina, 1206
Investigational Site Number 032003
Mar Del Plata, Argentina, 7602
Australia
Investigational Site Number 036002
Box Hill, Australia, 3128
Investigational Site Number 036004
Fitzroy, Australia, 3065
Investigational Site Number 036001
Geelong, Australia, 3220
Investigational Site Number 036003
Herston, Australia, 4029
Canada
Investigational Site Number 124003
Brampton, Canada, L6S 0C9
Investigational Site Number 124005
Burlington, Canada, L7M 4Y1
Investigational Site Number 124008
Chatham, Canada, N7L 1C1
Investigational Site Number 124010
Mirabel, Canada, J7J 2K8
Investigational Site Number 124009
Montreal, Canada, H2X 0A9
Investigational Site Number 124006
Sainte-Foy, Canada, G1W4R4
Investigational Site Number 124004
Thornhill, Canada, L4J 8L7
Investigational Site Number 124002
Toronto, Canada, M4G 3E8
Investigational Site Number 124001
Vancouver, Canada, V5Y 3W2
Investigational Site Number 124007
Vancouver, Canada, V5Z 1L8
Colombia
Investigational Site Number 170004
Armenia, Colombia, 630004
Investigational Site Number 170007
Barranquilla, Colombia, 80020
Investigational Site Number 170001
Bogota, Colombia, 110221
Investigational Site Number 170005
Bogota, Colombia, 111311
Investigational Site Number 170003
Manizales, Colombia, 170004
France
Investigational Site Number 250004
Lyon, France, 69495
Investigational Site Number 250006
Nantes Cedex 01, France, 44093
Investigational Site Number 250005
Poitiers Cedex, France, 86021
Germany
Investigational Site Number 276004
Dresden, Germany, 01307
Investigational Site Number 276003
Essen, Germany, 45359
Investigational Site Number 276001
München, Germany, 81925
Investigational Site Number 276005
Potsdam, Germany, 14469
Investigational Site Number 276002
Saarlouis, Germany, 66740
Hungary
Investigational Site Number 348004
Balatonfüred, Hungary, 8230
Investigational Site Number 348001
Budapest, Hungary, 1036
Investigational Site Number 348005
Budapest, Hungary, 1062
Investigational Site Number 348007
Budapest, Hungary, 1062
Investigational Site Number 348003
Budapest, Hungary, 1213
Investigational Site Number 348008
Csongrád, Hungary, 6640
Investigational Site Number 348009
Debrecen, Hungary, 4031
Investigational Site Number 348002
Gyula, Hungary, 5700
Italy
Investigational Site Number 380004
Bologna, Italy, 40138
Investigational Site Number 380005
Chieti, Italy, 66013
Investigational Site Number 380003
Genova, Italy, 16132
Investigational Site Number 380002
Milano, Italy, 20122
Investigational Site Number 380001
Milano, Italy, 20132
Japan
Investigational Site Number 392008
Adachi-Ku, Japan
Investigational Site Number 392003
Atsugi-Shi, Japan
Investigational Site Number 392002
Kamakura-Shi, Japan
Investigational Site Number 392010
Sagamihara-Shi, Japan
Investigational Site Number 392004
Sakado-Shi, Japan
Investigational Site Number 392013
Sapporo-Shi, Japan
Investigational Site Number 392012
Sendai-Shi, Japan
Korea, Republic of
Investigational Site Number 410003
Seoul, Korea, Republic of, 110-744
Investigational Site Number 410005
Seoul, Korea, Republic of, 110-746
Investigational Site Number 410002
Seoul, Korea, Republic of, 135-710
Investigational Site Number 410001
Seoul, Korea, Republic of, 136-705
Investigational Site Number 410004
Wonju, Korea, Republic of, 220-701
Mexico
Investigational Site Number 484002
Aguascalientes, Mexico, 20230
Investigational Site Number 484004
Cuernavaca, Mexico, 62250
Investigational Site Number 484001
Guadalajara, Mexico, 44150
Investigational Site Number 484003
Monterrey, Mexico, 64460
Peru
Investigational Site Number 604004
Arequipa, Peru
Investigational Site Number 604007
Ica, Peru, 056
Investigational Site Number 604002
Lima, Peru, 27
Investigational Site Number 604005
Lima, Peru, Lima 09
Investigational Site Number 604001
Lima, Peru, LIMA 14
Investigational Site Number 604006
Lima, Peru, Lima 32
Investigational Site Number 604003
Piura, Peru, 20001
Poland
Investigational Site Number 616005
Lublin, Poland, 20-538
Investigational Site Number 616004
Szczecin, Poland, 70-506
Investigational Site Number 616003
Warszawa, Poland, 02-507
Investigational Site Number 616002
Warszawa, Poland, 03-242
Investigational Site Number 616001
Zabrze, Poland, 41-800
Romania
Investigational Site Number 642006
Bacau, Romania, 600154
Investigational Site Number 642001
Bucuresti, Romania, 020042
Investigational Site Number 642007
Constanta, Romania, 900675
Investigational Site Number 642004
Oradea, Romania, 410159
Investigational Site Number 642005
Sibiu, Romania, 550371
Investigational Site Number 642002
Targu Mures, Romania, 540142
Investigational Site Number 642003
Targu Mures, Romania, 540142
Spain
Investigational Site Number 724004
Alzira, Spain, 46600
Investigational Site Number 724001
Badalona, Spain, 08916
Investigational Site Number 724002
El Ferrol, Spain, 15405
Investigational Site Number 724008
La Coruña, Spain, 15006
Investigational Site Number 724006
Málaga, Spain, 29010
Investigational Site Number 724007
Quart De Poblet, Spain, 46930
Investigational Site Number 724003
Sanlúcar De Barrameda, Spain, 11540
Investigational Site Number 724005
Sevilla, Spain, 41071
Sweden
Investigational Site Number 752002
Göteborg, Sweden, 405 45
Investigational Site Number 752004
Härnösand, Sweden, 871 82
Investigational Site Number 752003
Rättvik, Sweden, 79530
Investigational Site Number 752001
Västra Frölunda, Sweden, 421 44
United Kingdom
Investigational Site Number 826003
Belfast, United Kingdom, BT12 6BA
Investigational Site Number 826005
Belfast, United Kingdom, BT16 1RH
Investigational Site Number 826001
Bristol, United Kingdom, BS10 5NB
Investigational Site Number 826004
Redhill, United Kingdom, RH1 5RH
Investigational Site Number 826006
Rotherham, United Kingdom, S60 2UD
Investigational Site Number 826002
Swansea, United Kingdom, SA2 8PP
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02320721     History of Changes
Other Study ID Numbers: EFC13799
2014-002399-10
U1111-1159-3018 ( Other Identifier: UTN )
First Posted: December 19, 2014    Key Record Dates
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs