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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005101-36 | EudraCT Number | ||
| U1111-1177-6327 | Other Identifier | UTN |
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Primary Objective:
To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change from Baseline to Week 24.
Secondary Objectives:
Change From Baseline in HbA1c to Week 12
To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® at week 12 and week 24 on:
To assess the safety in each treatment group.
To assess the treatment effects in each treatment group on Patient Reported Outcomes (PRO).
Percentage of participants requiring rescue therapy.
The maximum study duration per participant was approximately 27 weeks: an up to 2-week screening period, a 24-week randomized treatment period (including 12 weeks active titration), and a 7-day posttreatment safety follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toujeo | Experimental | Toujeo® (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 24 on top of non-insulin antidiabetic treatment. |
|
| Tresiba | Active Comparator | Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin glargine, 300U/mL | 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 80 to 100 mg/dL (4.4 to 5.6 mmol/L). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c to Week 24 | Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Adjusted Least Square (LS) means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the 24-week on-treatment period. | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in HbA1c to Week 12 | Change in HbA1c was calculated by subtracting baseline value from Week 12 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM. | Baseline, Week 12 |
| Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Diabetes Treatment Satisfaction Questionnaire (DTSQ) Status at Week 12 and Week 24 | The DTSQs is a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consists of 8 items that are answered on a Likert scale from 0 to 6. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment). Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM. |
Inclusion criteria :
Exclusion criteria:
The above information is 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 840038 | Sheffield | Alabama | 35660 | United States | ||
| Investigational Site Number 840066 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30104294 | Derived | Rosenstock J, Cheng A, Ritzel R, Bosnyak Z, Devisme C, Cali AMG, Sieber J, Stella P, Wang X, Frias JP, Roussel R, Bolli GB. More Similarities Than Differences Testing Insulin Glargine 300 Units/mL Versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The Randomized Head-to-Head BRIGHT Trial. Diabetes Care. 2018 Oct;41(10):2147-2154. doi: 10.2337/dc18-0559. Epub 2018 Aug 13. |
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A total of 929 participants were randomized in 1:1 ratio to either Toujeo or Tresiba, stratified by screening glycated hemoglobin (HbA1c) values (<8% or >=8%); and use of sulfonylurea (SU) or meglitinides before the day of screening ('yes' versus 'no').
The study was conducted at 158 study centers across 16 countries. A total of 1376 participants were screened between 19 May 2016 and 19 February 2017, of whom 447 were screen failures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Toujeo | Toujeo® (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 24 on top of non-insulin antidiabetic treatment. |
| FG001 | Tresiba | Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2015 | Jul 18, 2018 |
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|
| Insulin degludec, 100 U/mL | 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 80 to 100 mg/dL (4.4 to 5.6 mmol/L). Route of administration: subcutaneous |
|
|
| Non-insulin anti-diabetic treatment | Drug | Background therapy: Oral Anti diabetics Drugs (OADs), Glucagon-like peptide-1 (GLP-1) receptor agonist. |
|
Change in FPG was calculated by subtracting baseline value from Week 12 and Week 24 value. Adjusted LS means were obtained from MMRM including post baseline values during the 24-week on-treatment period. |
| Baseline, Week 12 and Week 24 |
| Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24 | Fasting SMPG was measured by the participant before breakfast and before the administration of the glucose-lowering agents once a day during the study. Adjusted LS means were obtained from MMRM including post baseline values during the 24 week on treatment period. | Baseline, Week 12 and Week 24 |
| Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point | 8-point SMPG profiles were measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. | Baseline, Week 12 and Week 24 |
| Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point | 4-point SMPG profiles were measured at the following 4 points: prebreakfast, prelunch, predinner and bedtime. | Baseline, Week 12 and Week 24 |
| Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24 | The 8-point SMPG profile was measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Adjusted LS means were obtained from MMRM. | Baseline, Week 12 and Week 24 |
| Change From Baseline in Variability of Fasting SMPG to Week 12 and Week 24 | Adjusted LS means were obtained from MMRM. Variability was assessed by the mean of coefficient of variation calculated over at least 3 SMPG measured during the 7 days preceding the given visit. | Baseline, Week 12 and Week 24 |
| Change From Baseline in Variability of 24-Hour 8-Point SMPG Profiles at Week 12 and Week 24 | Adjusted LS means were obtained from MMRM. | Baseline, Week 12 and Week 24 |
| Percentage of Participants Reaching Target HbA1c of < 7% and =<6.5% at Week 12 and Week 24 | Only the post-baseline HbA1c measurements before rescue and during the 12 week and 24-week on-treatment period were considered in the analysis. | Week 12, and Week 24 |
| Percentage of Participants Reaching Target HbA1c <7% and =<6.5% at Week 12 and Week 24 Without Severe and/or Confirmed Hypoglycemia (70 mg/dL) Event | Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed by plasma glucose =<3.9 mmol/L (=<70 mg/dL). | Week 12, and Week 24 |
| Percentage of Participants With Sulphonylurea or Meglitinide Dose Reduction/ Discontinuation Due to Hypoglycemia During 24 Weeks Treatment Period | Percentage of participants With Sulphonylurea or Meglitinide dose reduction/ discontinuation due to Hypoglycemia during 24 Week treatment period were reported. Only participants with Sulphonylurea or meglitinides at Screening as per actual strata were taken into account in this analysis. | Baseline to Week 24 |
| Percentage of Participants Requiring a Rescue Therapy During 24 Weeks Treatment Period | Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. Threshold values at Week 12: FPG >200 mg/dL (11 mmol/L), or HbA1c >8.5%. | Baseline to Week 24 |
| Change From Baseline in Basal Insulin Dose (U/kg Body Weight) to Week 12 and Week 24 | Only the insulin dose measurements performed before initiation of rescue therapy and during the on-treatment period were considered in the analysis. | Baseline, Week 12 and Week 24 |
| Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) by Study Period | Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Assessment was done by treatment period (for =<12 weeks, for >12 weeks to =<24 weeks (24W)). Percentage of participants with at least one hypoglycemia (hypo) event at any time of the day were reported. | Day 1-Week 12, Week 13-Week 24, and 24 Week Period |
| Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal) by Study Period | Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycaemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time). Assessment was done by treatment period (for =<12 weeks, for >12 weeks to =<24 weeks). | Day 1-Week 12, Week 13-Week 24, and 24 Week Period |
| Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) Event Rate Per Participant Year During Study Period | Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). | Day 1-Week 12, Week 13-Week 24, and 24 Week Period |
| Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal ) Event Rate Per Participant Year During Study Period | Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time). | Day 1-Week 12, Week 13-Week 24, and 24 Week Period |
| Baseline, Week 12 and Week 24 |
| Phoenix |
| Arizona |
| 85020 |
| United States |
| Investigational Site Number 840051 | Anaheim | California | 92801 | United States |
| Investigational Site Number 840081 | Chino | California | 91710 | United States |
| Investigational Site Number 840016 | Huntington Park | California | 90255 | United States |
| Investigational Site Number 840002 | La Jolla | California | 92037 | United States |
| Investigational Site Number 840091 | Los Angeles | California | 90017 | United States |
| Investigational Site Number 840058 | Northridge | California | 91324 | United States |
| Investigational Site Number 840021 | Palm Springs | California | 92262 | United States |
| Investigational Site Number 840087 | Santa Ana | California | 92704 | United States |
| Investigational Site Number 840030 | Torrance | California | 90505 | United States |
| Investigational Site Number 840065 | Van Nuys | California | 91405 | United States |
| Investigational Site Number 840075 | Bradenton | Florida | 34201 | United States |
| Investigational Site Number 840076 | New Port Richey | Florida | 34652 | United States |
| Investigational Site Number 840026 | Ocoee | Florida | 34761 | United States |
| Investigational Site Number 840052 | Palm Harbor | Florida | 34684 | United States |
| Investigational Site Number 840080 | Palm Harbor | Florida | 34684 | United States |
| Investigational Site Number 840018 | Port Charlotte | Florida | 33952 | United States |
| Investigational Site Number 840071 | Lawrenceville | Georgia | 30046 | United States |
| Investigational Site Number 840085 | Roswell | Georgia | 30076 | United States |
| Investigational Site Number 840072 | Statesboro | Georgia | 30461 | United States |
| Investigational Site Number 840039 | Stockbridge | Georgia | 30281 | United States |
| Investigational Site Number 840036 | Arlington Heights | Illinois | 60005 | United States |
| Investigational Site Number 840010 | Chicago | Illinois | 60616 | United States |
| Investigational Site Number 840005 | Avon | Indiana | 46123 | United States |
| Investigational Site Number 840063 | Council Bluffs | Iowa | 51501 | United States |
| Investigational Site Number 840098 | Des Moines | Iowa | 50134 | United States |
| Investigational Site Number 840101 | Des Moines | Iowa | 50314 | United States |
| Investigational Site Number 840096 | West Des Moines | Iowa | 50266 | United States |
| Investigational Site Number 840061 | Paris | Kentucky | 40361 | United States |
| Investigational Site Number 840011 | Hyattsville | Maryland | 20782 | United States |
| Investigational Site Number 840001 | Rockville | Maryland | 20852 | United States |
| Investigational Site Number 840041 | Flint | Michigan | 48504 | United States |
| Investigational Site Number 840057 | Flint | Michigan | 48532 | United States |
| Investigational Site Number 840033 | Troy | Michigan | 48085 | United States |
| Investigational Site Number 840084 | Olive Branch | Mississippi | 38654 | United States |
| Investigational Site Number 840048 | Chesterfield | Missouri | 63017 | United States |
| Investigational Site Number 840023 | Las Vegas | Nevada | 89117 | United States |
| Investigational Site Number 840045 | Las Vegas | Nevada | 89128 | United States |
| Investigational Site Number 840031 | Linden | New Jersey | 07036 | United States |
| Investigational Site Number 840060 | Hickory | North Carolina | 28601 | United States |
| Investigational Site Number 840064 | Morganton | North Carolina | 28655 | United States |
| Investigational Site Number 840043 | Wilmington | North Carolina | 28401 | United States |
| Investigational Site Number 840082 | Winston-Salem | North Carolina | 27103 | United States |
| Investigational Site Number 840025 | Oklahoma City | Oklahoma | 73104 | United States |
| Investigational Site Number 840022 | Oklahoma City | Oklahoma | 73112 | United States |
| Investigational Site Number 840029 | Beaver | Pennsylvania | 15009 | United States |
| Investigational Site Number 840056 | Downingtown | Pennsylvania | 19335 | United States |
| Investigational Site Number 840093 | Anderson | South Carolina | 29621 | United States |
| Investigational Site Number 840097 | Greenville | South Carolina | 29605 | United States |
| Investigational Site Number 840070 | Greer | South Carolina | 29651 | United States |
| Investigational Site Number 840044 | North Myrtle Beach | South Carolina | 29582 | United States |
| Investigational Site Number 840069 | Simpsonville | South Carolina | 29681 | United States |
| Investigational Site Number 840079 | Bristol | Tennessee | United States |
| Investigational Site Number 840006 | Chattanooga | Tennessee | 37404 | United States |
| Investigational Site Number 840088 | Knoxville | Tennessee | 37912 | United States |
| Investigational Site Number 840077 | New Tazewell | Tennessee | 37825 | United States |
| Investigational Site Number 840007 | Dallas | Texas | 75230 | United States |
| Investigational Site Number 840086 | Dallas | Texas | 75231 | United States |
| Investigational Site Number 840027 | Houston | Texas | 77061 | United States |
| Investigational Site Number 840004 | Houston | Texas | 77083-4436 | United States |
| Investigational Site Number 840040 | Houston | Texas | 77090 | United States |
| Investigational Site Number 840046 | Houston | Texas | 77095 | United States |
| Investigational Site Number 840054 | Hurst | Texas | 76054 | United States |
| Investigational Site Number 840017 | Mesquite | Texas | 75149 | United States |
| Investigational Site Number 840008 | Missouri City | Texas | 77459 | United States |
| Investigational Site Number 840094 | San Antonio | Texas | 78229-3907 | United States |
| Investigational Site Number 840009 | Sugar Land | Texas | 77478 | United States |
| Investigational Site Number 840053 | Waco | Texas | 76710 | United States |
| Investigational Site Number 840095 | Ogden | Utah | 84405 | United States |
| Investigational Site Number 840032 | Salt Lake City | Utah | 84102 | United States |
| Investigational Site Number 840024 | Norfolk | Virginia | United States |
| Investigational Site Number 840020 | Richmond | Virginia | 23219 | United States |
| Investigational Site Number 840012 | Renton | Washington | 98055 | United States |
| Investigational Site Number 100001 | Sofia | 1431 | Bulgaria |
| Investigational Site Number 100002 | Sofia | 1505 | Bulgaria |
| Investigational Site Number 100003 | Sofia | Bulgaria |
| Investigational Site Number 191001 | Rijeka | 51000 | Croatia |
| Investigational Site Number 191002 | Rijeka | 51000 | Croatia |
| Investigational Site Number 191003 | Zagreb | Croatia |
| Investigational Site Number 203009 | Hlučín | Czechia |
| Investigational Site Number 203006 | Jílové u Prahy | 25401 | Czechia |
| Investigational Site Number 203005 | Liberec | 46001 | Czechia |
| Investigational Site Number 203001 | Pardubice | 53002 | Czechia |
| Investigational Site Number 203007 | Prague | 11000 | Czechia |
| Investigational Site Number 203008 | Prague | 12808 | Czechia |
| Investigational Site Number 203002 | Prague | 18100 | Czechia |
| Investigational Site Number 203004 | Vsetín | 75501 | Czechia |
| Investigational Site Number 208003 | Aarhus | 8000 | Denmark |
| Investigational Site Number 208002 | Hillerød | 3400 | Denmark |
| Investigational Site Number 208001 | København NV | 2400 | Denmark |
| Investigational Site Number 208004 | Odense | 5000 | Denmark |
| Investigational Site Number 250002 | La Roche-sur-Yon | 85025 | France |
| Investigational Site Number 250003 | La Rochelle | 17019 | France |
| Investigational Site Number 250001 | Nantes | 44093 | France |
| Investigational Site Number 250006 | Nîmes | 30029 | France |
| Investigational Site Number 250005 | Poitiers | 86021 | France |
| Investigational Site Number 250007 | Vénissieux | 69200 | France |
| Investigational Site Number 300005 | Alexandroupoli | 68100 | Greece |
| Investigational Site Number 300001 | Athens | 17562 | Greece |
| Investigational Site Number 300002 | Athens | Greece |
| Investigational Site Number 300003 | Athens | Greece |
| Investigational Site Number 348004 | Budapest | 1042 | Hungary |
| Investigational Site Number 348002 | Budapest | 1083 | Hungary |
| Investigational Site Number 348001 | Budapest | 1106 | Hungary |
| Investigational Site Number 348003 | Gyöngyös | 3200 | Hungary |
| Investigational Site Number 376001 | Haifa | 31096 | Israel |
| Investigational Site Number 376004 | Haifa | Israel |
| Investigational Site Number 376008 | Haifa | Israel |
| Investigational Site Number 376009 | Kfar Saba | Israel |
| Investigational Site Number 376002 | Petah Tikva | Israel |
| Investigational Site Number 376006 | Tel Aviv | Israel |
| Investigational Site Number 376007 | Tel Aviv | Israel |
| Investigational Site Number 376003 | Tel Litwinsky | 52621 | Israel |
| Investigational Site Number 380007 | Bari | 70124 | Italy |
| Investigational Site Number 380009 | Catanzaro | Italy |
| Investigational Site Number 380010 | Chieti | 66013 | Italy |
| Investigational Site Number 380014 | Milan | 20132 | Italy |
| Investigational Site Number 380002 | Moncalieri | 10024 | Italy |
| Investigational Site Number 380011 | Naples | 80131 | Italy |
| Investigational Site Number 380008 | Roma | Italy |
| Investigational Site Number 380015 | Roma | Italy |
| Investigational Site Number 380016 | Roma | Italy |
| Investigational Site Number 380013 | Sesto San Giovanni | 20099 | Italy |
| Investigational Site Number 380005 | Torino | 10126 | Italy |
| Investigational Site Number 380012 | Verona | 37126 | Italy |
| Investigational Site Number 642007 | Brasov | 500097 | Romania |
| Investigational Site Number 642008 | Brasov | 500326 | Romania |
| Investigational Site Number 642001 | Bucharest | 022441 | Romania |
| Investigational Site Number 642013 | Bucharest | 040172 | Romania |
| Investigational Site Number 642015 | Bucharest | Romania |
| Investigational Site Number 642003 | Cluj-Napoca | 400006 | Romania |
| Investigational Site Number 642009 | Constanța | 900675 | Romania |
| Investigational Site Number 642014 | Iași | 700547 | Romania |
| Investigational Site Number 642005 | Oradea | Romania |
| Investigational Site Number 642012 | Oradea | Romania |
| Investigational Site Number 642010 | Târgu Mureş | 540015 | Romania |
| Investigational Site Number 642004 | Târgu Mureş | 540142 | Romania |
| Investigational Site Number 642006 | Târgu Mureş | Romania |
| Investigational Site Number 688001 | Belgrade | 11000 | Serbia |
| Investigational Site Number 688002 | Niš | Serbia |
| Investigational Site Number 688003 | Niš | Serbia |
| Investigational Site Number 703006 | Košice | 04013 | Slovakia |
| Investigational Site Number 703002 | Ľubochňa | 03491 | Slovakia |
| Investigational Site Number 703001 | Moldava nad Bodvou | 04525 | Slovakia |
| Investigational Site Number 703003 | Sabinov | 08301 | Slovakia |
| Investigational Site Number 703005 | Trebišov | 07501 | Slovakia |
| Investigational Site Number 752102 | Lund | 22241 | Sweden |
| Investigational Site Number 752101 | Skövde | 54150 | Sweden |
| Investigational Site Number 756003 | Olten | 4600 | Switzerland |
| Investigational Site Number 756001 | Sankt Gallen | 9016 | Switzerland |
| Investigational Site Number 826001 | Chertsey | KT160PZ | United Kingdom |
| Investigational Site Number 826005 | Gillingham | ME75NY | United Kingdom |
| Investigational Site Number 826008 | Lincoln | LN25QY | United Kingdom |
| Investigational Site Number 826002 | London | SW109NH | United Kingdom |
| Investigational Site Number 826009 | Manchester | M415SL | United Kingdom |
| Investigational Site Number 826006 | Margate | CT94ANA | United Kingdom |
| Investigational Site Number 826004 | Swansea | SA66NL | United Kingdom |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline population included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Toujeo | Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment. |
| BG001 | Tresiba | Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | Kg/m^2 |
| |||||||||||||||
| Duration of Type 2 Diabetes Mellitus | Mean | Standard Deviation | years |
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| Baseline HbA1c | Mean | Standard Deviation | Percentage of HbA1c |
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| Basal Insulin Daily Dose | Number of participants analyzed = participants with available data for specified measure. | Mean | Standard Deviation | Units per kilogram (U/kg) |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in HbA1c to Week 24 | Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Adjusted Least Square (LS) means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the 24-week on-treatment period. | Intent-to-treat(ITT) population: all randomized participants who received at least 1 dose of IMP, regardless of whether treatment was actually being received & analyzed as per allocated treatment group. Overall number of participants analyzed=participants with at least 1 baseline & 1 post-baseline HbA1c assessment during 24week on-treatment period. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline, Week 24 |
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| Secondary | Change From Baseline in HbA1c to Week 12 | Change in HbA1c was calculated by subtracting baseline value from Week 12 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM. | ITT population. Here, overall number of participants analyzed = participants with at least one baseline and one post-baseline HbA1c assessment during the 12 week on-treatment period. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline, Week 12 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24 | Change in FPG was calculated by subtracting baseline value from Week 12 and Week 24 value. Adjusted LS means were obtained from MMRM including post baseline values during the 24-week on-treatment period. | ITT population. Here, number analyzed = participants with at least one baseline and one post baseline FPG values at specified timepoints. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 12 and Week 24 |
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| Secondary | Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24 | Fasting SMPG was measured by the participant before breakfast and before the administration of the glucose-lowering agents once a day during the study. Adjusted LS means were obtained from MMRM including post baseline values during the 24 week on treatment period. | ITT population. Here, overall number analyzed =participants with at least one baseline and one post baseline fasting SMPG values at specified timepoints. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 12 and Week 24 |
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| Secondary | Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point | 8-point SMPG profiles were measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. | ITT population. Number Analyzed = participants with at least one baseline and one post baseline 8 Point SMPG values at specified time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 12 and Week 24 |
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| Secondary | Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point | 4-point SMPG profiles were measured at the following 4 points: prebreakfast, prelunch, predinner and bedtime. | ITT population. Number analyzed = Participants with at least one baseline and one post-baseline 4-point SMPG values at specified timepoints. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 12 and Week 24 |
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| Secondary | Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24 | The 8-point SMPG profile was measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Adjusted LS means were obtained from MMRM. | ITT population. Here, number analyzed = Participants with at least one baseline and one post-baseline 24-hour average SMPG values at specified time points. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 12 and Week 24 |
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| Secondary | Change From Baseline in Variability of Fasting SMPG to Week 12 and Week 24 | Adjusted LS means were obtained from MMRM. Variability was assessed by the mean of coefficient of variation calculated over at least 3 SMPG measured during the 7 days preceding the given visit. | ITT population. Number Analyzed = participants with at least one baseline and one post baseline Fasting SMPG values at specified time point. | Posted | Least Squares Mean | Standard Error | percentage of mean variability | Baseline, Week 12 and Week 24 |
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| Secondary | Change From Baseline in Variability of 24-Hour 8-Point SMPG Profiles at Week 12 and Week 24 | Adjusted LS means were obtained from MMRM. | ITT population. Here, number analyzed = Participants with at least one baseline and one post-baseline 24-hour average SMPG values at specified time points. | Posted | Least Squares Mean | Standard Error | percentage of mean variability | Baseline, Week 12 and Week 24 |
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| Secondary | Percentage of Participants Reaching Target HbA1c of < 7% and =<6.5% at Week 12 and Week 24 | Only the post-baseline HbA1c measurements before rescue and during the 12 week and 24-week on-treatment period were considered in the analysis. | ITT population. | Posted | Number | percentage of participants | Week 12, and Week 24 |
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| Secondary | Percentage of Participants Reaching Target HbA1c <7% and =<6.5% at Week 12 and Week 24 Without Severe and/or Confirmed Hypoglycemia (70 mg/dL) Event | Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed by plasma glucose =<3.9 mmol/L (=<70 mg/dL). | ITT population. | Posted | Number | percentage of participants | Week 12, and Week 24 |
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| Secondary | Percentage of Participants With Sulphonylurea or Meglitinide Dose Reduction/ Discontinuation Due to Hypoglycemia During 24 Weeks Treatment Period | Percentage of participants With Sulphonylurea or Meglitinide dose reduction/ discontinuation due to Hypoglycemia during 24 Week treatment period were reported. Only participants with Sulphonylurea or meglitinides at Screening as per actual strata were taken into account in this analysis. | ITT population. | Posted | Number | percentage of participants | Baseline to Week 24 |
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| Secondary | Percentage of Participants Requiring a Rescue Therapy During 24 Weeks Treatment Period | Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. Threshold values at Week 12: FPG >200 mg/dL (11 mmol/L), or HbA1c >8.5%. | ITT population. | Posted | Number | percentage of participants | Baseline to Week 24 |
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| Secondary | Change From Baseline in Basal Insulin Dose (U/kg Body Weight) to Week 12 and Week 24 | Only the insulin dose measurements performed before initiation of rescue therapy and during the on-treatment period were considered in the analysis. | Safety population included all randomized participants who did actually receive at least one dose of IMP, regardless of the amount of treatment administered. | Posted | Mean | Standard Deviation | Units per kilogram (U/kg) | Baseline, Week 12 and Week 24 |
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| Secondary | Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) by Study Period | Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Assessment was done by treatment period (for =<12 weeks, for >12 weeks to =<24 weeks (24W)). Percentage of participants with at least one hypoglycemia (hypo) event at any time of the day were reported. | Safety population. | Posted | Number | percentage of participants | Day 1-Week 12, Week 13-Week 24, and 24 Week Period |
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| Secondary | Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal) by Study Period | Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycaemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time). Assessment was done by treatment period (for =<12 weeks, for >12 weeks to =<24 weeks). | Safety population included all randomized participants who did actually receive at least one dose of IMP, regardless of the amount of treatment administered. | Posted | Number | percentage of participants | Day 1-Week 12, Week 13-Week 24, and 24 Week Period |
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| Secondary | Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) Event Rate Per Participant Year During Study Period | Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). | Safety population | Posted | Number | Events per participant year | Day 1-Week 12, Week 13-Week 24, and 24 Week Period |
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| Other Pre-specified | Change From Baseline in Total Diabetes Treatment Satisfaction Questionnaire (DTSQ) Status at Week 12 and Week 24 | The DTSQs is a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consists of 8 items that are answered on a Likert scale from 0 to 6. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment). Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM. | ITT population. Number Analyzed = participants with at least one baseline and one post-baseline DTSQ status (DTSQs) total score. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 12 and Week 24 |
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| Secondary | Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal ) Event Rate Per Participant Year During Study Period | Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time). | Safety population | Posted | Number | Events per participant year | Day 1-Week 12, Week 13-Week 24, and 24 Week Period |
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All Adverse Events were collected from signature of the informed consent form until 7 days after last treatment administration (maximum exposure: 24 Weeks).
Reported adverse events and death were treatment-emergent adverse events that is adverse events that developed/worsened during the 'on treatment period' (On-treatment period was defined as the time from the first injection of open-label Investigational Medicinal Product (IMP) up to 7 days after the last injection of open-label IMP, regardless of the introduction of rescue therapy). Analysis was performed on safety population.
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 | Toujeo | Toujeo® (Insulin glargine, 300 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment. | 1 | 462 | 21 | 462 | 56 | 462 |
| EG001 | Tresiba | Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment. | 0 | 462 | 20 | 462 | 58 | 462 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Atrial Flutter | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Coronary Artery Disease | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Coronary Artery Insufficiency | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| Retinal Haemorrhage | Eye disorders | MedDRA 20.0 | Systematic Assessment |
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| Gastric Ulcer | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Rectal Fissure | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Non-Cardiac Chest Pain | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Bacterial Pyelonephritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Acoustic Neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Adenocarcinoma Of Colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Carcinoid Tumour Pulmonary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Pancreatic Carcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Carpal Tunnel Syndrome | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Ischaemic Stroke | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Trigeminal Neuralgia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Alcohol Abuse | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Drug Use Disorder | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Major Depression | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Aortic Stenosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
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| Hypertensive Crisis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
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| Varicose Ulceration | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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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 | 800-633-1610 | 1# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 3, 2017 | Jul 18, 2018 | SAP_001.pdf |
| 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 |
| C571886 | insulin degludec |
| 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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Non-inferiority of Toujeo vs Tresiba was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was <0.3%. |
| Superiority of Toujeo over Tresiba was demonstrated if the upper bound of the two-sided 95% CI for the difference in the mean change in HbA1c from baseline to Week 24 between Toujeo over Tresiba on ITT population was <0 (zero). | Mixed Models Analysis | 0.3302 | LS Mean Difference | -0.05 | Standard Error of the Mean | 0.052 | 2-Sided | 95 | -0.152 | 0.051 | Superiority |
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