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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002399-10 | |||
| U1111-1159-3018 | Other Identifier | UTN |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HOE901-U300 | Experimental | HOE901-U300 (Insulin glargine, 300 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy. |
|
| Lantus | Active Comparator | Lantus (Insulin glargine, 100 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine (HOE901 - U300) | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment | 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). |
Inclusion criteria:
Exclusion criteria:
HbA1c at screening visit:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840058 | Saraland | Alabama | 36571 | United States | ||
| Investigational Site Number 840019 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29895556 | Result | Ritzel R, Harris SB, Baron H, Florez H, Roussel R, Espinasse M, Muehlen-Bartmer I, Zhang N, Bertolini M, Brulle-Wohlhueter C, Munshi M, Bolli GB. A Randomized Controlled Trial Comparing Efficacy and Safety of Insulin Glargine 300 Units/mL Versus 100 Units/mL in Older People With Type 2 Diabetes: Results From the SENIOR Study. Diabetes Care. 2018 Aug;41(8):1672-1680. doi: 10.2337/dc18-0168. Epub 2018 Jun 12. |
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A total of 1014 participants were randomized in 1:1 ratio to either HOE901-U300 or Lantus, stratified by screening hemoglobin A1c (HbA1c) values (<8% or ≥8%); previous use of insulin (insulin-naïve versus pre-treated); and use of sulfonylurea or meglitinides at screening ('yes' versus 'no').
The study was conducted at 162 study centers across 18 countries. A total of 1515 participants were screened between 16 January 2015 and 14 October 2015, of whom 501 were screen failures.
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| ID | Title | Description |
|---|---|---|
| FG000 | HOE901-U300 | HOE901-U300 (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy. |
| FG001 | Lantus |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
| Insulin Glargine (HOE901 - U100) | Drug | 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). |
|
|
| Background therapy | Drug | Non-insulin anti-diabetic drugs with the exception of thiazolidinediones. |
|
| Baseline up to Week 26 |
| 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). | Baseline up to Week 26 |
| 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). | Baseline up to Week 26 |
| 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. | Baseline up to Week 26 |
| 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). | Baseline up to Week 26 |
| 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. | Baseline, Week 26 |
| 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). | Baseline, Week 26 |
| 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%. | Baseline up to Week 26 |
| Baseline up to Week 26 |
| Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year During the 26 Weeks of Treatment | 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). | Baseline up to Week 26 |
| Fresno |
| California |
| 93720 |
| United States |
| Investigational Site Number 840021 | Fresno | California | 93722 | United States |
| Investigational Site Number 840040 | Greenbrae | California | 94904 | United States |
| Investigational Site Number 840070 | Huntington Park | California | 90255 | United States |
| Investigational Site Number 840064 | Los Angeles | California | 90057 | United States |
| Investigational Site Number 840031 | Norwalk | California | 90650 | United States |
| Investigational Site Number 840065 | Oakland | California | 94612 | United States |
| Investigational Site Number 840050 | Orange | California | 92868 | United States |
| Investigational Site Number 840036 | Simi Valley | California | 93065 | United States |
| Investigational Site Number 840003 | Temecula | California | 92591 | United States |
| Investigational Site Number 840062 | Walnut Creek | California | 94598 | United States |
| Investigational Site Number 840027 | Longmont | Colorado | 80501 | United States |
| Investigational Site Number 840030 | Bradenton | Florida | 34208 | United States |
| Investigational Site Number 840010 | Miami | Florida | 33156 | United States |
| Investigational Site Number 840035 | Miami | Florida | 33156 | United States |
| Investigational Site Number 840014 | New Port Richey | Florida | 34652 | United States |
| Investigational Site Number 840051 | Ocoee | Florida | 34761 | United States |
| Investigational Site Number 840056 | Palm Harbor | Florida | 34684 | United States |
| Investigational Site Number 840007 | St. Petersburg | Florida | United States |
| Investigational Site Number 840041 | Roswell | Georgia | 30076 | United States |
| Investigational Site Number 840053 | Statesboro | Georgia | 30461 | United States |
| Investigational Site Number 840042 | Woodstock | Georgia | 30189 | United States |
| Investigational Site Number 840005 | Arlington Heights | Illinois | 60005 | United States |
| Investigational Site Number 840004 | Peoria | Illinois | 61602 | United States |
| Investigational Site Number 840029 | Springfield | Illinois | 62704 | United States |
| Investigational Site Number 840013 | Avon | Indiana | 46123 | United States |
| Investigational Site Number 840023 | Avon | Indiana | 46123 | United States |
| Investigational Site Number 840039 | Evansville | Indiana | 47714 | United States |
| Investigational Site Number 840006 | Muncie | Indiana | 47304 | United States |
| Investigational Site Number 840026 | Des Moines | Iowa | 50314 | United States |
| Investigational Site Number 840033 | West Des Moines | Iowa | 50266 | United States |
| Investigational Site Number 840032 | Overland Park | Kansas | 66209 | United States |
| Investigational Site Number 840069 | Metairie | Louisiana | 70006 | United States |
| Investigational Site Number 840020 | Flint | Michigan | 48504 | United States |
| Investigational Site Number 840037 | Nashua | New Hampshire | 03063 | United States |
| Investigational Site Number 840018 | New York | New York | 10001 | United States |
| Investigational Site Number 840048 | Asheville | North Carolina | 28805 | United States |
| Investigational Site Number 840009 | Charlotte | North Carolina | 28209 | United States |
| Investigational Site Number 840011 | Greensboro | North Carolina | 27408 | United States |
| Investigational Site Number 840047 | Greenville | North Carolina | 27834 | United States |
| Investigational Site Number 840016 | Salisbury | North Carolina | 28144 | United States |
| Investigational Site Number 840012 | Wilmington | North Carolina | 28401 | United States |
| Investigational Site Number 840022 | Fargo | North Dakota | 58103 | United States |
| Investigational Site Number 840072 | Cincinnati | Ohio | 45219 | United States |
| Investigational Site Number 840054 | Wadsworth | Ohio | 44281 | United States |
| Investigational Site Number 840067 | Bend | Oregon | 97702 | United States |
| Investigational Site Number 840057 | Corvallis | Oregon | 97330 | United States |
| Investigational Site Number 840045 | Feasterville | Pennsylvania | 19053 | United States |
| Investigational Site Number 840017 | Pittsburgh | Pennsylvania | 15220 | United States |
| Investigational Site Number 840059 | Greenville | South Carolina | 29605 | United States |
| Investigational Site Number 840015 | Greer | South Carolina | 29651 | United States |
| Investigational Site Number 840002 | Chattanooga | Tennessee | 37404 | United States |
| Investigational Site Number 840046 | Chattanooga | Tennessee | 37404 | United States |
| Investigational Site Number 840034 | Knoxville | Tennessee | 37912 | United States |
| Investigational Site Number 840055 | Arlington | Texas | 76014 | United States |
| Investigational Site Number 840001 | Dallas | Texas | 75230 | United States |
| Investigational Site Number 840024 | Irving | Texas | 75039 | United States |
| Investigational Site Number 840061 | North Richland Hills | Texas | 76180 | United States |
| Investigational Site Number 840028 | Richmond | Texas | 77469 | United States |
| Investigational Site Number 840063 | San Antonio | Texas | 78230 | United States |
| Investigational Site Number 840038 | St. George | Utah | 84790 | United States |
| Investigational Site Number 840025 | Federal Way | Washington | 98003 | United States |
| Investigational Site Number 840060 | Bridgeport | West Virginia | 26330 | United States |
| Investigational Site Number 032001 | Caba | 1120 | Argentina |
| Investigational Site Number 032002 | Caba | 1405 | Argentina |
| Investigational Site Number 032006 | Capital Federal | 1180 | Argentina |
| Investigational Site Number 032004 | Ciudad Autonoma de Buenos Aire | 1206 | Argentina |
| Investigational Site Number 032003 | Mar del Plata | 7602 | Argentina |
| Investigational Site Number 036002 | Box Hill | 3128 | Australia |
| Investigational Site Number 036004 | Fitzroy | 3065 | Australia |
| Investigational Site Number 036001 | Geelong | 3220 | Australia |
| Investigational Site Number 036003 | Herston | 4029 | Australia |
| Investigational Site Number 124003 | Brampton | L6S 0C9 | Canada |
| Investigational Site Number 124005 | Burlington | L7M 4Y1 | Canada |
| Investigational Site Number 124008 | Chatham | N7L 1C1 | Canada |
| Investigational Site Number 124010 | Mirabel | J7J 2K8 | Canada |
| Investigational Site Number 124009 | Montreal | H2X 0A9 | Canada |
| Investigational Site Number 124006 | Sainte-Foy | G1W4R4 | Canada |
| Investigational Site Number 124004 | Thornhill | L4J 8L7 | Canada |
| Investigational Site Number 124002 | Toronto | M4G 3E8 | Canada |
| Investigational Site Number 124001 | Vancouver | V5Y 3W2 | Canada |
| Investigational Site Number 124007 | Vancouver | V5Z 1L8 | Canada |
| Investigational Site Number 170004 | Armenia | 630004 | Colombia |
| Investigational Site Number 170007 | Barranquilla | 80020 | Colombia |
| Investigational Site Number 170001 | Bogotá | 110221 | Colombia |
| Investigational Site Number 170005 | Bogotá | 111311 | Colombia |
| Investigational Site Number 170003 | Manizales | 170004 | Colombia |
| Investigational Site Number 250004 | Lyon | 69495 | France |
| Investigational Site Number 250006 | Nantes | 44093 | France |
| Investigational Site Number 250005 | Poitiers | 86021 | France |
| Investigational Site Number 276004 | Dresden | 01307 | Germany |
| Investigational Site Number 276003 | Essen | 45359 | Germany |
| Investigational Site Number 276001 | München | 81925 | Germany |
| Investigational Site Number 276005 | Potsdam | 14469 | Germany |
| Investigational Site Number 276002 | Saarlouis | 66740 | Germany |
| Investigational Site Number 348004 | Balatonfüred | 8230 | Hungary |
| Investigational Site Number 348001 | Budapest | 1036 | Hungary |
| Investigational Site Number 348005 | Budapest | 1062 | Hungary |
| Investigational Site Number 348007 | Budapest | 1062 | Hungary |
| Investigational Site Number 348003 | Budapest | 1213 | Hungary |
| Investigational Site Number 348008 | Csongrád | 6640 | Hungary |
| Investigational Site Number 348009 | Debrecen | 4031 | Hungary |
| Investigational Site Number 348002 | Gyula | 5700 | Hungary |
| Investigational Site Number 380004 | Bologna | 40138 | Italy |
| Investigational Site Number 380005 | Chieti | 66013 | Italy |
| Investigational Site Number 380003 | Genova | 16132 | Italy |
| Investigational Site Number 380002 | Milan | 20122 | Italy |
| Investigational Site Number 380001 | Milan | 20132 | Italy |
| 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 | Japan |
| Investigational Site Number 392012 | Sendai | Japan |
| Investigational Site Number 484002 | Aguascalientes | 20230 | Mexico |
| Investigational Site Number 484004 | Cuernavaca | 62250 | Mexico |
| Investigational Site Number 484001 | Guadalajara | 44150 | Mexico |
| Investigational Site Number 484003 | Monterrey | 64460 | Mexico |
| Investigational Site Number 604004 | Arequipa | Peru |
| Investigational Site Number 604007 | Ica | 056 | Peru |
| Investigational Site Number 604002 | Lima | 27 | Peru |
| Investigational Site Number 604005 | Lima | Lima 09 | Peru |
| Investigational Site Number 604001 | Lima | LIMA 14 | Peru |
| Investigational Site Number 604006 | Lima | Lima 32 | Peru |
| Investigational Site Number 604003 | Piura | 20001 | Peru |
| Investigational Site Number 616005 | Lublin | 20-538 | Poland |
| Investigational Site Number 616004 | Szczecin | 70-506 | Poland |
| Investigational Site Number 616003 | Warsaw | 02-507 | Poland |
| Investigational Site Number 616002 | Warsaw | 03-242 | Poland |
| Investigational Site Number 616001 | Zabrze | 41-800 | Poland |
| Investigational Site Number 642006 | Bacau | 600154 | Romania |
| Investigational Site Number 642001 | Bucharest | 020042 | Romania |
| Investigational Site Number 642007 | Constanța | 900675 | Romania |
| Investigational Site Number 642004 | Oradea | 410159 | Romania |
| Investigational Site Number 642005 | Sibiu | 550371 | Romania |
| Investigational Site Number 642002 | Târgu Mureş | 540142 | Romania |
| Investigational Site Number 642003 | Târgu Mureş | 540142 | Romania |
| Investigational Site Number 410003 | Seoul | 110-744 | South Korea |
| Investigational Site Number 410005 | Seoul | 110-746 | South Korea |
| Investigational Site Number 410002 | Seoul | 135-710 | South Korea |
| Investigational Site Number 410001 | Seoul | 136-705 | South Korea |
| Investigational Site Number 410004 | Wŏnju | 220-701 | South Korea |
| Investigational Site Number 724008 | A Coruña | 15006 | Spain |
| Investigational Site Number 724004 | Alzira | 46600 | Spain |
| Investigational Site Number 724001 | Badalona | 08916 | Spain |
| Investigational Site Number 724002 | Ferrol | 15405 | Spain |
| Investigational Site Number 724006 | Málaga | 29010 | Spain |
| Investigational Site Number 724007 | Quart de Poblet | 46930 | Spain |
| Investigational Site Number 724003 | Sanlúcar de Barrameda | 11540 | Spain |
| Investigational Site Number 724005 | Seville | 41071 | Spain |
| Investigational Site Number 752002 | Gothenburg | 405 45 | Sweden |
| Investigational Site Number 752004 | Härnösand | 871 82 | Sweden |
| Investigational Site Number 752003 | Rättvik | 79530 | Sweden |
| Investigational Site Number 752001 | Västra Frölunda | 421 44 | Sweden |
| Investigational Site Number 826003 | Belfast | BT12 6BA | United Kingdom |
| Investigational Site Number 826005 | Belfast | BT16 1RH | United Kingdom |
| Investigational Site Number 826001 | Bristol | BS10 5NB | United Kingdom |
| Investigational Site Number 826004 | Redhill | RH1 5RH | United Kingdom |
| Investigational Site Number 826006 | Rotherham | S60 2UD | United Kingdom |
| Investigational Site Number 826002 | Swansea | SA2 8PP | United Kingdom |
Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.
| Treated (Safety Population) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HOE901-U300 | HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy. |
| BG001 | Lantus | Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Number of participants analyzed = participants with available data for this baseline measure. | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Duration of Type 2 Diabetes | Mean | Standard Deviation | years |
| |||||||||||||||
| Baseline Glycated Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | percentage of HbA1c |
| |||||||||||||||
| Randomization strata of insulin | Count of Participants | Participants |
| ||||||||||||||||
| Age Group | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent-to-treat (ITT) population included all randomized participants regardless of whether the treatment kit was used, and analyzed according to the treatment group allocated by randomization. | Posted | Least Squares Mean | Standard Error | percentage of hemoglobin | Baseline, Week 26 |
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| Secondary | 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). | ITT population. | Posted | Number | percentage of participants | Baseline up to Week 26 |
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| Secondary | 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). | ITT population. | Posted | Number | percentage of participants | Baseline up to Week 26 |
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| Secondary | 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). | ITT population. | Posted | Number | percentage of participants | Baseline up to Week 26 |
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| Secondary | 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. | ITT population. | Posted | Number | percentage of participants | Baseline up to Week 26 |
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| Secondary | 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). | ITT population. | Posted | Number | percentage of participants | Baseline up to Week 26 |
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| Secondary | 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. | ITT population. Here 'Overall number of participants analyzed' signifies participants with available data for this outcome measure. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 26 |
|
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| Secondary | 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). | ITT population. Here 'Overall number of participants analyzed' signifies participants with available data for this outcome measure. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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%. | ITT population. | Posted | Number | percentage of participants | Baseline up to Week 26 |
|
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| Other Pre-specified | Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment | 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). | Safety population included all randomized participants who actually received at least 1 dose or part of a dose of investigational medicinal product (IMP) and analyzed according to the treatment actually received. | Posted | Number | percentage of participants | Baseline up to Week 26 |
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| Other Pre-specified | Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year During the 26 Weeks of Treatment | 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). | Safety population. | Posted | Number | events per participant year | Baseline up to Week 26 |
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| Post-Hoc | Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year: By Age Categorical Data During the 26 Weeks of Treatment | 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). | Safety population. | Posted | Number | events per participant year | Baseline up to Week 26 |
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All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 184) regardless of seriousness or relationship to IMP.
Reported AEs and deaths were treatment emergent that is AEs that developed/worsened and deaths that occurred during 'on treatment period' (from first dose of IMP injection up to 2 days after the last injection of IMP, regardless of introduction of rescue therapy). Analysis was performed using safety population which included all the treated participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HOE901-U300 | HOE901-U300 (Insulin glargine, 300 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy. | 1 | 508 | 41 | 508 | 62 | 508 |
| EG001 | Lantus | Lantus (Insulin glargine, 100 U/mL) SC injection once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy. | 0 | 505 | 34 | 505 | 64 | 505 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Adrenal mass | Endocrine disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Bacterial pyelonephritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Heart injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Endometrial cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| IIIrd nerve paresis | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neuromyopathy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral venous disease | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
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| Insulin pre-treated |
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| ≥75 years of age |
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| Counts |
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| Participants |
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