Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: Insulin Glargine (HOE901 - U300)Drug: Insulin Glargine (HOE901 - U100)Drug: Background therapy
- Registration Number
- NCT02320721
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1014
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HOE901-U300 Insulin Glargine (HOE901 - U300) HOE901-U300 (Insulin glargine, 300 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy. HOE901-U300 Background therapy HOE901-U300 (Insulin glargine, 300 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy. Lantus Insulin Glargine (HOE901 - U100) Lantus (Insulin glargine, 100 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy. Lantus Background therapy Lantus (Insulin glargine, 100 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
- Primary Outcome Measures
Name Time Method Change in HbA1c From Baseline to Week 26 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
Name Time Method 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 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 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 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).
Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26 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 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%.
Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period 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 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 Baseline, Week 26 Adjusted LS means from multiple imputation approach including post baseline values during the 26-week randomized period.
Trial Locations
- Locations (162)
Investigational Site Number 840021
🇺🇸Fresno, California, United States
Investigational Site Number 840019
🇺🇸Fresno, California, United States
Investigational Site Number 840030
🇺🇸Bradenton, Florida, United States
Investigational Site Number 840048
🇺🇸Asheville, North Carolina, United States
Investigational Site Number 840064
🇺🇸Los Angeles, California, United States
Investigational Site Number 170005
🇨🇴Bogota, Colombia
Investigational Site Number 348005
🇭🇺Budapest, Hungary
Investigational Site Number 348004
🇭🇺Balatonfüred, Hungary
Investigational Site Number 348007
🇭🇺Budapest, Hungary
Investigational Site Number 348008
🇭🇺Csongrád, Hungary
Investigational Site Number 348003
🇭🇺Budapest, Hungary
Investigational Site Number 484003
🇲🇽Monterrey, Mexico
Investigational Site Number 604004
🇵🇪Arequipa, Peru
Investigational Site Number 616005
🇵🇱Lublin, Poland
Investigational Site Number 616001
🇵🇱Zabrze, Poland
Investigational Site Number 642003
🇷🇴Targu Mures, Romania
Investigational Site Number 604001
🇵🇪Lima, Peru
Investigational Site Number 642004
🇷🇴Oradea, Romania
Investigational Site Number 642002
🇷🇴Targu Mures, Romania
Investigational Site Number 840017
🇺🇸Pittsburgh, Pennsylvania, United States
Investigational Site Number 840040
🇺🇸Greenbrae, California, United States
Investigational Site Number 840034
🇺🇸Knoxville, Tennessee, United States
Investigational Site Number 032003
🇦🇷Mar Del Plata, Argentina
Investigational Site Number 840038
🇺🇸Saint George, Utah, United States
Investigational Site Number 840060
🇺🇸Bridgeport, West Virginia, United States
Investigational Site Number 124010
🇨🇦Mirabel, Canada
Investigational Site Number 036004
🇦🇺Fitzroy, Australia
Investigational Site Number 840002
🇺🇸Chattanooga, Tennessee, United States
Investigational Site Number 840046
🇺🇸Chattanooga, Tennessee, United States
Investigational Site Number 036002
🇦🇺Box Hill, Australia
Investigational Site Number 840015
🇺🇸Greer, South Carolina, United States
Investigational Site Number 840025
🇺🇸Federal Way, Washington, United States
Investigational Site Number 276003
🇩🇪Essen, Germany
Investigational Site Number 032004
🇦🇷Ciudad Autonoma De Buenos Aire, Argentina
Investigational Site Number 032001
🇦🇷Caba, Argentina
Investigational Site Number 036003
🇦🇺Herston, Australia
Investigational Site Number 276001
🇩🇪München, Germany
Investigational Site Number 410003
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 170007
🇨🇴Barranquilla, Colombia
Investigational Site Number 380004
🇮🇹Bologna, Italy
Investigational Site Number 380002
🇮🇹Milano, Italy
Investigational Site Number 840001
🇺🇸Dallas, Texas, United States
Investigational Site Number 840024
🇺🇸Irving, Texas, United States
Investigational Site Number 840028
🇺🇸Richmond, Texas, United States
Investigational Site Number 032006
🇦🇷Capital Federal, Argentina
Investigational Site Number 124001
🇨🇦Vancouver, Canada
Investigational Site Number 276005
🇩🇪Potsdam, Germany
Investigational Site Number 170004
🇨🇴Armenia, Colombia
Investigational Site Number 170001
🇨🇴Bogota, Colombia
Investigational Site Number 170003
🇨🇴Manizales, Colombia
Investigational Site Number 348009
🇭🇺Debrecen, Hungary
Investigational Site Number 348002
🇭🇺Gyula, Hungary
Investigational Site Number 410001
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 348001
🇭🇺Budapest, Hungary
Investigational Site Number 124003
🇨🇦Brampton, Canada
Investigational Site Number 276004
🇩🇪Dresden, Germany
Investigational Site Number 380005
🇮🇹Chieti, Italy
Investigational Site Number 840061
🇺🇸North Richland Hills, Texas, United States
Investigational Site Number 840055
🇺🇸Arlington, Texas, United States
Investigational Site Number 380001
🇮🇹Milano, Italy
Investigational Site Number 124005
🇨🇦Burlington, Canada
Investigational Site Number 392008
🇯🇵Adachi-Ku, Japan
Investigational Site Number 032002
🇦🇷Caba, Argentina
Investigational Site Number 124002
🇨🇦Toronto, Canada
Investigational Site Number 124004
🇨🇦Thornhill, Canada
Investigational Site Number 124007
🇨🇦Vancouver, Canada
Investigational Site Number 124009
🇨🇦Montreal, Canada
Investigational Site Number 250006
🇫🇷Nantes Cedex 01, France
Investigational Site Number 250005
🇫🇷Poitiers Cedex, France
Investigational Site Number 276002
🇩🇪Saarlouis, Germany
Investigational Site Number 124008
🇨🇦Chatham, Canada
Investigational Site Number 752002
🇸🇪Göteborg, Sweden
Investigational Site Number 752004
🇸🇪Härnösand, Sweden
Investigational Site Number 380003
🇮🇹Genova, Italy
Investigational Site Number 410004
🇰🇷Wonju, Korea, Republic of
Investigational Site Number 826005
🇬🇧Belfast, United Kingdom
Investigational Site Number 392004
🇯🇵Sakado-Shi, Japan
Investigational Site Number 392012
🇯🇵Sendai-Shi, Japan
Investigational Site Number 724004
🇪🇸Alzira, Spain
Investigational Site Number 724007
🇪🇸Quart De Poblet, Spain
Investigational Site Number 826001
🇬🇧Bristol, United Kingdom
Investigational Site Number 484001
🇲🇽Guadalajara, Mexico
Investigational Site Number 604007
🇵🇪Ica, Peru
Investigational Site Number 604005
🇵🇪Lima, Peru
Investigational Site Number 642007
🇷🇴Constanta, Romania
Investigational Site Number 724005
🇪🇸Sevilla, Spain
Investigational Site Number 392010
🇯🇵Sagamihara-Shi, Japan
Investigational Site Number 484004
🇲🇽Cuernavaca, Mexico
Investigational Site Number 604002
🇵🇪Lima, Peru
Investigational Site Number 604006
🇵🇪Lima, Peru
Investigational Site Number 826004
🇬🇧Redhill, United Kingdom
Investigational Site Number 642001
🇷🇴Bucuresti, Romania
Investigational Site Number 724002
🇪🇸El Ferrol, Spain
Investigational Site Number 604003
🇵🇪Piura, Peru
Investigational Site Number 616003
🇵🇱Warszawa, Poland
Investigational Site Number 616002
🇵🇱Warszawa, Poland
Investigational Site Number 642005
🇷🇴Sibiu, Romania
Investigational Site Number 724008
🇪🇸La Coruña, Spain
Investigational Site Number 826003
🇬🇧Belfast, United Kingdom
Investigational Site Number 724006
🇪🇸Málaga, Spain
Investigational Site Number 724003
🇪🇸Sanlúcar De Barrameda, Spain
Investigational Site Number 840010
🇺🇸Miami, Florida, United States
Investigational Site Number 840035
🇺🇸Miami, Florida, United States
Investigational Site Number 840063
🇺🇸San Antonio, Texas, United States
Investigational Site Number 752001
🇸🇪Västra Frölunda, Sweden
Investigational Site Number 392002
🇯🇵Kamakura-Shi, Japan
Investigational Site Number 036001
🇦🇺Geelong, Australia
Investigational Site Number 840011
🇺🇸Greensboro, North Carolina, United States
Investigational Site Number 840070
🇺🇸Huntington Park, California, United States
Investigational Site Number 840003
🇺🇸Temecula, California, United States
Investigational Site Number 840065
🇺🇸Oakland, California, United States
Investigational Site Number 840050
🇺🇸Orange, California, United States
Investigational Site Number 840036
🇺🇸Simi Valley, California, United States
Investigational Site Number 840031
🇺🇸Norwalk, California, United States
Investigational Site Number 840062
🇺🇸Walnut Creek, California, United States
Investigational Site Number 840027
🇺🇸Longmont, Colorado, United States
Investigational Site Number 840051
🇺🇸Ocoee, Florida, United States
Investigational Site Number 840014
🇺🇸New Port Richey, Florida, United States
Investigational Site Number 840056
🇺🇸Palm Harbor, Florida, United States
Investigational Site Number 840041
🇺🇸Roswell, Georgia, United States
Investigational Site Number 840007
🇺🇸Saint Petersburg, Florida, United States
Investigational Site Number 840029
🇺🇸Springfield, Illinois, United States
Investigational Site Number 840005
🇺🇸Arlington Heights, Illinois, United States
Investigational Site Number 840042
🇺🇸Woodstock, Georgia, United States
Investigational Site Number 840023
🇺🇸Avon, Indiana, United States
Investigational Site Number 840004
🇺🇸Peoria, Illinois, United States
Investigational Site Number 840053
🇺🇸Statesboro, Georgia, United States
Investigational Site Number 840013
🇺🇸Avon, Indiana, United States
Investigational Site Number 840039
🇺🇸Evansville, Indiana, United States
Investigational Site Number 840006
🇺🇸Muncie, Indiana, United States
Investigational Site Number 840026
🇺🇸Des Moines, Iowa, United States
Investigational Site Number 840032
🇺🇸Overland Park, Kansas, United States
Investigational Site Number 840020
🇺🇸Flint, Michigan, United States
Investigational Site Number 840037
🇺🇸Nashua, New Hampshire, United States
Investigational Site Number 840033
🇺🇸West Des Moines, Iowa, United States
Investigational Site Number 840069
🇺🇸Metairie, Louisiana, United States
Investigational Site Number 840018
🇺🇸New York, New York, United States
Investigational Site Number 840009
🇺🇸Charlotte, North Carolina, United States
Investigational Site Number 840047
🇺🇸Greenville, North Carolina, United States
Investigational Site Number 840016
🇺🇸Salisbury, North Carolina, United States
Investigational Site Number 840012
🇺🇸Wilmington, North Carolina, United States
Investigational Site Number 840022
🇺🇸Fargo, North Dakota, United States
Investigational Site Number 840072
🇺🇸Cincinnati, Ohio, United States
Investigational Site Number 840054
🇺🇸Wadsworth, Ohio, United States
Investigational Site Number 840057
🇺🇸Corvallis, Oregon, United States
Investigational Site Number 840067
🇺🇸Bend, Oregon, United States
Investigational Site Number 840045
🇺🇸Feasterville, Pennsylvania, United States
Investigational Site Number 840059
🇺🇸Greenville, South Carolina, United States
Investigational Site Number 124006
🇨🇦Sainte-Foy, Canada
Investigational Site Number 250004
🇫🇷Lyon, France
Investigational Site Number 392003
🇯🇵Atsugi-Shi, Japan
Investigational Site Number 410005
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410002
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 392013
🇯🇵Sapporo-Shi, Japan
Investigational Site Number 484002
🇲🇽Aguascalientes, Mexico
Investigational Site Number 642006
🇷🇴Bacau, Romania
Investigational Site Number 616004
🇵🇱Szczecin, Poland
Investigational Site Number 724001
🇪🇸Badalona, Spain
Investigational Site Number 826002
🇬🇧Swansea, United Kingdom
Investigational Site Number 752003
🇸🇪Rättvik, Sweden
Investigational Site Number 826006
🇬🇧Rotherham, United Kingdom
Investigational Site Number 840058
🇺🇸Saraland, Alabama, United States