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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004096-38 | EudraCT Number | ||
| U1111-1131-4936 | Other Identifier | UTN |
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Primary Objective:
- To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin.
Secondary Objectives:
- To compare the treatments/regimens on:
Approximately 41 weeks including a 26 week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lixisenatide | Experimental | Lixisenatide 10 mcg once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin. |
|
| Insulin Glulisine QD | Active Comparator | Insulin glulisine QD from randomization up to Week 26 on top of Insulin glargine with or without metformin. |
|
| Insulin Glulisine TID | Active Comparator | Insulin glulisine thrice daily (TID) from randomization up to Week 26 on top of Insulin glargine with or without metformin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lixisenatide (AVE0010) | Drug | Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection 30 to 60 minutes before breakfast or dinner. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline to Week 26 | Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period. | Baseline, Week 26 |
| Change in Body Weight From Baseline to Week 26 | Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID. Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. | Baseline, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26 | The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Missing data was imputed using LOCF. | Week 26 |
| Percentage of Participants With no Weight Gain at Week 26 |
Not provided
Inclusion criteria :
Exclusion criteria:
Exclusion Criteria for randomization at the end of the screening period before randomization:
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 840043 | Sun City | Arizona | 85351 | United States | ||
| Investigational Site Number 840042 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27222510 | Result | Rosenstock J, Guerci B, Hanefeld M, Gentile S, Aronson R, Tinahones FJ, Roy-Duval C, Souhami E, Wardecki M, Ye J, Perfetti R, Heller S; GetGoal Duo-2 Trial Investigators. Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial. Diabetes Care. 2016 Aug;39(8):1318-28. doi: 10.2337/dc16-0014. Epub 2016 May 23. | |
| 31848983 |
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Participants underwent a 12-week run-in period with switch from other basal insulins to insulin glargine. A total of 1265 participants were screen failures/run-in failures; the most frequent reason for run-in failure was that glycosylated hemoglobin (HbA1c) criteria were not met at the end of run-in phase. 894 participants were randomized.
The study was conducted at 199 centers in 18 countries. A total of 2159 participants were screened between January 08, 2013 and April 10, 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lixisenatide | Lixisenatide 10 mcg once daily (QD) subcutaneously (SC) for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin. |
| FG001 | Insulin Glulisine QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Insulin glulisine QD | Drug | Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before breakfast or dinner. The initial dose was 3-5 units and then individually titrated to obtain the SMPG value >5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before lunch (if administered at breakfast) or at bedtime (if administered at dinner). |
|
|
| Insulin glulisine TID | Drug | Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before each meal. The initial dose was 3-5 units for each meal and then individually titrated to obtain the SMPG value >5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before the next meal or at bedtime (for injection at dinner). |
|
|
| Insulin Glargine (Mandatory background drug) | Drug | Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection at breakfast or dinner. Doses were adjusted to maintain a fasting self-monitored plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL). |
|
|
| Metformin (Background drug) | Drug | Pharmaceutical form: Tablet; Route of administration: Oral administration. If previously taken, Metformin to be continued at stable dose (≥1.5 g/day) throughout the study. |
|
The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 3 days after the last dose of study drug. |
| Week 26 |
| Change in Average 7-point SMPG Profiles From Baseline to Week 26 | Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. | Baseline, Week 26 |
| Change in FPG From Baseline to Week 26 | Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. | Baseline, Week 26 |
| Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast) | The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. | Baseline, Week 26 |
| Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast) | Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change in glucose excursions was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. | Baseline, Week 26 |
| Change in Insulin Glargine Dose From Baseline to Week 26 | Change in Insulin glargine dose was calculated by subtracting the baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. | Baseline, Week 26 |
| Insulin Glulisine Dose at Week 26 | The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF. | Week 26 |
| Total Insulin Dose at Week 26 | The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF. The outcome is reporting results of total insulin (amounts of Insulin Glargine plus Insulin Glulisine ) only for the arms in which Insulin Glulisine was administered and is not applicable for the lixisenatide arm in which only Insulin Glargine is administered. Change in dose of the insulin used by patients in the Lixisenatide arm (i.e. Insulin Glargine) is reported in the secondary Outcome Measure 9. | Week 26 |
| Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia | Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <60 mg/dL (3.3 mmol/L). Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. | First dose of study drug up to 3 days after the last dose administration (maximum of 185 days) |
| Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period | The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. | Week 26 |
| Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26 | The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. | Week 26 |
| Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period | The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. Participants without post-baseline on-treatment values (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response, or if they experienced at least one documented symptomatic hypoglycemia during the on-treatment period. Otherwise, they were counted as missing data. | Week 26 |
| Tempe |
| Arizona |
| 85282 |
| United States |
| Investigational Site Number 840003 | Little Rock | Arkansas | 72205 | United States |
| Investigational Site Number 840031 | La Mesa | California | 91942 | United States |
| Investigational Site Number 840005 | Mission Viejo | California | 92691 | United States |
| Investigational Site Number 840057 | Northridge | California | 91325 | United States |
| Investigational Site Number 840035 | Santa Ana | California | 92704 | United States |
| Investigational Site Number 840002 | Temecula | California | 92591 | United States |
| Investigational Site Number 840037 | Walnut Creek | California | 94598 | United States |
| Investigational Site Number 840023 | West Hills | California | 91345 | United States |
| Investigational Site Number 840041 | Denver | Colorado | 80246 | United States |
| Investigational Site Number 840012 | Miami | Florida | 33136 | United States |
| Investigational Site Number 840061 | Miami | Florida | 33142 | United States |
| Investigational Site Number 840045 | Lawrenceville | Georgia | 30045 | United States |
| Investigational Site Number 840036 | Nampa | Idaho | 83686 | United States |
| Investigational Site Number 840024 | Chicago | Illinois | 60611 | United States |
| Investigational Site Number 840009 | Evanston | Illinois | 60201 | United States |
| Investigational Site Number 840004 | Avon | Indiana | 46123 | United States |
| Investigational Site Number 840055 | Avon | Indiana | 46123 | United States |
| Investigational Site Number 840027 | Des Moines | Iowa | 50314 | United States |
| Investigational Site Number 840006 | Wichita | Kansas | 67203 | United States |
| Investigational Site Number 840047 | Lexington | Kentucky | 40504 | United States |
| Investigational Site Number 840056 | Paducah | Kentucky | 42003 | United States |
| Investigational Site Number 840022 | Marrero | Louisiana | 70072 | United States |
| Investigational Site Number 840016 | Baltimore | Maryland | 21237 | United States |
| Investigational Site Number 840017 | Rockville | Maryland | 20852 | United States |
| Investigational Site Number 840025 | Buckley | Michigan | 49620 | United States |
| Investigational Site Number 840048 | Dearborn | Michigan | 48124 | United States |
| Investigational Site Number 840026 | Kalamazoo | Michigan | 49048 | United States |
| Investigational Site Number 840049 | Las Vegas | Nevada | 89148 | United States |
| Investigational Site Number 840029 | New Hyde Park | New York | 11042 | United States |
| Investigational Site Number 840060 | Smithtown | New York | 11787 | United States |
| Investigational Site Number 840030 | Staten Island | New York | 10301-3914 | United States |
| Investigational Site Number 840011 | Salisbury | North Carolina | 28144 | United States |
| Investigational Site Number 840028 | Fargo | North Dakota | 58103 | United States |
| Investigational Site Number 840007 | Oklahoma City | Oklahoma | 73104 | United States |
| Investigational Site Number 840021 | Pittsburgh | Pennsylvania | 15212 | United States |
| Investigational Site Number 840052 | Myrtle Beach | South Carolina | 29572 | United States |
| Investigational Site Number 840032 | Chattanooga | Tennessee | 37404 | United States |
| Investigational Site Number 840033 | Nashville | Tennessee | 37232 | United States |
| Investigational Site Number 840034 | Corpus Christi | Texas | 78404 | United States |
| Investigational Site Number 840001 | Dallas | Texas | 75230 | United States |
| Investigational Site Number 840020 | Houston | Texas | 77081 | United States |
| Investigational Site Number 840018 | Norfolk | Virginia | 23502 | United States |
| Investigational Site Number 840015 | Salem | Virginia | 24153 | United States |
| Investigational Site Number 840010 | Milwaukee | Wisconsin | 53217 | United States |
| Investigational Site Number 124008 | Brampton | L6R 3J5 | Canada |
| Investigational Site Number 124015 | Burlington | L7M 4Y1 | Canada |
| Investigational Site Number 124018 | Chatham | N7L 1C1 | Canada |
| Investigational Site Number 124004 | Coquitlam | V3K 3P4 | Canada |
| Investigational Site Number 124016 | Etobicoke | M9R 4E1 | Canada |
| Investigational Site Number 124014 | Hamilton | L8L 5G8 | Canada |
| Investigational Site Number 124020 | Montreal | H1Y 3L1 | Canada |
| Investigational Site Number 124011 | Montreal | H3A 1A1 | Canada |
| Investigational Site Number 124017 | Newmarket | L3Y 5G8 | Canada |
| Investigational Site Number 124021 | Québec | G1N 4V3 | Canada |
| Investigational Site Number 124003 | Red Deer | T4N 6V7 | Canada |
| Investigational Site Number 124012 | Saint Romuald | G6W 5M6 | Canada |
| Investigational Site Number 124002 | Sherbrooke | J1H 5N4 | Canada |
| Investigational Site Number 124001 | Toronto | M4G 3E8 | Canada |
| Investigational Site Number 124010 | Toronto | M5C 2T2 | Canada |
| Investigational Site Number 124005 | Vancouver | V5Z 1M9 | Canada |
| Investigational Site Number 124006 | Victoria | V8V 4A1 | Canada |
| Investigational Site Number 124007 | Winnipeg | R3E 3P4 | Canada |
| Investigational Site Number 152103 | Santiago | 7500010 | Chile |
| Investigational Site Number 152107 | Santiago | 7500347 | Chile |
| Investigational Site Number 152101 | Santiago | 7500710 | Chile |
| Investigational Site Number 152105 | Santiago | 7591047 | Chile |
| Investigational Site Number 152102 | Santiago | 7980378 | Chile |
| Investigational Site Number 152106 | Santiago | 8053095 | Chile |
| Investigational Site Number 152108 | Santiago | 8053095 | Chile |
| Investigational Site Number 152109 | Santiago | Chile |
| Investigational Site Number 203107 | Beroun | 26601 | Czechia |
| Investigational Site Number 203103 | Jílové u Prahy | 254 01 | Czechia |
| Investigational Site Number 203101 | Ostrava | 702 00 | Czechia |
| Investigational Site Number 203110 | Police nad Metují | 549 54 | Czechia |
| Investigational Site Number 203105 | Prague | 14021 | Czechia |
| Investigational Site Number 203102 | Prague | 148 00 | Czechia |
| Investigational Site Number 203108 | Prague | 14900 | Czechia |
| Investigational Site Number 203104 | Trutnov | 54101 | Czechia |
| Investigational Site Number 233102 | Pärnu | 80018 | Estonia |
| Investigational Site Number 233103 | Tallinn | 13415 | Estonia |
| Investigational Site Number 233104 | Tallinn | 13419 | Estonia |
| Investigational Site Number 233101 | Viljandimaa | 71024 | Estonia |
| Investigational Site Number 250108 | Bois-Guillaume | 76230 | France |
| Investigational Site Number 250105 | Corbeil-Essonnes | 91100 | France |
| Investigational Site Number 250104 | La Rochelle | 17019 | France |
| Investigational Site Number 250106 | Lyon | 69495 | France |
| Investigational Site Number 250107 | Lyon | 69495 | France |
| Investigational Site Number 250109 | Mantes-la-Jolie | 78200 | France |
| Investigational Site Number 250102 | Paris | 75908 | France |
| Investigational Site Number 250101 | Vandœuvre-lès-Nancy | 54511 | France |
| Investigational Site Number 250103 | Vénissieux | 69200 | France |
| Investigational Site Number 276112 | Bad Mergentheim | 97980 | Germany |
| Investigational Site Number 276108 | Berlin | 13125 | Germany |
| Investigational Site Number 276102 | Dortmund | 44137 | Germany |
| Investigational Site Number 276120 | Dresden | 01067 | Germany |
| Investigational Site Number 276106 | Dresden | 01307 | Germany |
| Investigational Site Number 276117 | Frankfurt A.M. | 60596 | Germany |
| Investigational Site Number 276116 | Görlitz | 02826 | Germany |
| Investigational Site Number 276113 | Heidelberg | 69115 | Germany |
| Investigational Site Number 276118 | Leipzig | 04103 | Germany |
| Investigational Site Number 276119 | Magdeburg | 39104 | Germany |
| Investigational Site Number 276103 | Neumünster | 24534 | Germany |
| Investigational Site Number 276109 | Saint Ingbert-Oberwürzbach | 66386 | Germany |
| Investigational Site Number 276115 | Speyer | 67346 | Germany |
| Investigational Site Number 348107 | Budapest | 1134 | Hungary |
| Investigational Site Number 348108 | Budapest | 1138 | Hungary |
| Investigational Site Number 348102 | Budapest | 1139 | Hungary |
| Investigational Site Number 348101 | Eger | 3300 | Hungary |
| Investigational Site Number 348103 | Pápa | 8500 | Hungary |
| Investigational Site Number 348106 | Sátoraljaújhely | 3980 | Hungary |
| Investigational Site Number 348104 | Szeged | 6720 | Hungary |
| Investigational Site Number 348105 | Zalaegerszeg | 8900 | Hungary |
| Investigational Site Number 380103 | Bologna | 40138 | Italy |
| Investigational Site Number 380102 | Catania | 95122 | Italy |
| Investigational Site Number 380101 | Milan | 20132 | Italy |
| Investigational Site Number 380105 | Naples | 80131 | Italy |
| Investigational Site Number 380104 | Torino | 10126 | Italy |
| Investigational Site Number 428103 | Jelgava | LV-3001 | Latvia |
| Investigational Site Number 428104 | Ogre | LV-5001 | Latvia |
| Investigational Site Number 428102 | Riga | LV-1002 | Latvia |
| Investigational Site Number 428105 | Riga | LV-1006 | Latvia |
| Investigational Site Number 428101 | Sigulda | LV-2150 | Latvia |
| Investigational Site Number 440104 | Jonava | LT-55201 | Lithuania |
| Investigational Site Number 440103 | Kaunas | LT-48259 | Lithuania |
| Investigational Site Number 440102 | Kaunas | LT-49456 | Lithuania |
| Investigational Site Number 440101 | Kaunas | LT-51270 | Lithuania |
| Investigational Site Number 440105 | Klaipėda | LT-92288 | Lithuania |
| Investigational Site Number 484108 | Chihuahua City | 31200 | Mexico |
| Investigational Site Number 484101 | Cuernavaca | 62250 | Mexico |
| Investigational Site Number 484111 | Durango | 34080 | Mexico |
| Investigational Site Number 484104 | Guadalajara | 44150 | Mexico |
| Investigational Site Number 484109 | Guadalajara | 44210 | Mexico |
| Investigational Site Number 484107 | Guadalajara | 44600 | Mexico |
| Investigational Site Number 484105 | Guadalajara | 44650 | Mexico |
| Investigational Site Number 484110 | Guadalajara | 44656 | Mexico |
| Investigational Site Number 484103 | Mexico City | 11850 | Mexico |
| Investigational Site Number 484102 | México | 06700 | Mexico |
| Investigational Site Number 484106 | Monterrey | 64000 | Mexico |
| Investigational Site Number 616101 | Bialystok | 15-435 | Poland |
| Investigational Site Number 616103 | Bydgoszcz | 85-822 | Poland |
| Investigational Site Number 616102 | Bytom | 41-902 | Poland |
| Investigational Site Number 616106 | Krakow | 31-455 | Poland |
| Investigational Site Number 616104 | Krakow | 31-548 | Poland |
| Investigational Site Number 616105 | Puławy | 24-100 | Poland |
| Investigational Site Number 616107 | Warsaw | 02-507 | Poland |
| Investigational Site Number 642105 | Bacau | 600114 | Romania |
| Investigational Site Number 642108 | Cluj-Napoca | 400006 | Romania |
| Investigational Site Number 642106 | Deva | 330084 | Romania |
| Investigational Site Number 642113 | Galati | 800098 | Romania |
| Investigational Site Number 642107 | Hunedoara | 331057 | Romania |
| Investigational Site Number 642117 | Iași | 700547 | Romania |
| Investigational Site Number 642103 | Oradea | 410169 | Romania |
| Investigational Site Number 642104 | Oradea | 410169 | Romania |
| Investigational Site Number 642112 | Piteşti | 110084 | Romania |
| Investigational Site Number 642114 | Ploieşti | 100342 | Romania |
| Investigational Site Number 642102 | Reşiţa | 320076 | Romania |
| Investigational Site Number 642111 | Sibiu | 550371 | Romania |
| Investigational Site Number 642109 | Târgu Mureş | 540142 | Romania |
| Investigational Site Number 642110 | Târgu Mureş | 540142 | Romania |
| Investigational Site Number 642116 | Timișoara | 300133 | Romania |
| Investigational Site Number 642101 | Timișoara | 300456 | Romania |
| Investigational Site Number 642115 | Timișoara | 300723 | Romania |
| Investigational Site Number 643111 | Moscow | 117036 | Russia |
| Investigational Site Number 643107 | Moscow | 119991 | Russia |
| Investigational Site Number 643105 | Moscow | 129110 | Russia |
| Investigational Site Number 643110 | Penza | 440026 | Russia |
| Investigational Site Number 643101 | Saint Petersburg | 194044 | Russia |
| Investigational Site Number 643104 | Saint Petersburg | 194354 | Russia |
| Investigational Site Number 643109 | Saint Petersburg | 194354 | Russia |
| Investigational Site Number 643106 | Saint Petersburg | 194358 | Russia |
| Investigational Site Number 643108 | Saint Petersburg | 195112 | Russia |
| Investigational Site Number 643103 | Saint Petersburg | 195257 | Russia |
| Investigational Site Number 643102 | Saratov | 410030 | Russia |
| Investigational Site Number 724105 | A Coruña | 15006 | Spain |
| Investigational Site Number 724102 | Ferrol | 15403 | Spain |
| Investigational Site Number 724103 | Málaga | 29010 | Spain |
| Investigational Site Number 724104 | Seville | 41010 | Spain |
| Investigational Site Number 804104 | Chernivtsi | 58022 | Ukraine |
| Investigational Site Number 804107 | Donetsk | 83003 | Ukraine |
| Investigational Site Number 804103 | Donetsk | 83059 | Ukraine |
| Investigational Site Number 804108 | Mykolaiv | 54003 | Ukraine |
| Investigational Site Number 804110 | Odesa | 65059 | Ukraine |
| Investigational Site Number 804105 | Vinnytsia | 21001 | Ukraine |
| Investigational Site Number 804102 | Vinnytsia | 21010 | Ukraine |
| Investigational Site Number 804111 | Zaporizhia | 69600 | Ukraine |
| Investigational Site Number 826006 | Ashton-under-Lyne | OL6 9RW | United Kingdom |
| Investigational Site Number 826002 | Birmingham | B9 5SS | United Kingdom |
| Investigational Site Number 826007 | Carmarthen | SA31 2AF | United Kingdom |
| Investigational Site Number 826005 | Chester | CH2 1UL | United Kingdom |
| Investigational Site Number 826008 | Coventry | CV1 4FH | United Kingdom |
| Investigational Site Number 826009 | Dundee | DD1 9SI | United Kingdom |
| Investigational Site Number 826001 | Durham | DH1 5TW | United Kingdom |
| Investigational Site Number 826011 | Haddington | EH41 3PF | United Kingdom |
| Investigational Site Number 826012 | Leicester | LE5 4PW | United Kingdom |
| Investigational Site Number 826010 | Plymouth | PL6 8BX | United Kingdom |
| Investigational Site Number 826004 | Sheffield | S5 7AU | United Kingdom |
| Investigational Site Number 826003 | St Helens | WA93DA | United Kingdom |
| Derived |
| Tabak AG, Anderson J, Aschner P, Liu M, Saremi A, Stella P, Tinahones FJ, Wysham C, Meier JJ. Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis. Diabetes Ther. 2020 Jan;11(1):305-318. doi: 10.1007/s13300-019-00735-7. Epub 2019 Dec 17. |
| 29974618 | Derived | Rosenstock J, Handelsman Y, Vidal J, Ampudia Blasco FJ, Giorgino F, Liu M, Perfetti R, Meier JJ. Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes. Diabetes Obes Metab. 2018 Dec;20(12):2821-2829. doi: 10.1111/dom.13462. Epub 2018 Aug 13. |
Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
| FG002 | Insulin Glulisine TID | Insulin glulisine thrice daily (TID) SC up to Week 26 on top of insulin glargine with or without metformin. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lixisenatide | Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin. |
| BG001 | Insulin Glulisine QD | Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin. |
| BG002 | Insulin Glulisine TID | Insulin glulisine TID SC up to Week 26 on top of insulin glargine with or without metformin. |
| BG003 | 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 |
| |||||||||||||||
| Gender | Count of Participants | Participants |
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| Race | Number | participants |
| ||||||||||||||||
| Ethnicity | Number | participants |
| ||||||||||||||||
| Metformin Use at Screening | Number | participants |
| ||||||||||||||||
| Number of Participants with Categorical Body Mass Index (BMI) | Number | participants |
| ||||||||||||||||
| BMI | 893 participants (298 in Lixisenatide arm; 298 in Insulin glulisine QD and 297 in Insulin glulisine TID) were included for baseline BMI analysis. | Mean | Standard Deviation | kg/m^2 |
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| Weight | 893 participants (298 in Lixisenatide arm, 298 in Insulin glulisine QD and 297 in Insulin glulisine TID) were included for baseline weight analysis. | Mean | Standard Deviation | kg |
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| HbA1c | 893 participants (298 in Lixisenatide arm; 298 in Insulin glulisine QD and 297 in Insulin glulisine TID) were included for HbA1c analysis. | Mean | Standard Deviation | percentage of hemoglobin |
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| Fasting Plasma Glucose (FPG) | 893 participants (298 in Lixisenatide arm; 298 in Insulin glulisine QD and 297 in Insulin glulisine TID) were included for FPG analysis. | Mean | Standard Deviation | mmol/L |
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| 2-Hour Postprandial Plasma Glucose (PPG) | 258 participants (79 in Lixisenatide arm; 77 in Insulin glulisine QD and 102 in Insulin glulisine TID) were included for PPG analysis. | Mean | Standard Deviation | mmol/L |
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| 2-Hour Glucose Excursion | 243 participants (73 in Lixisenatide arm, 74 in Insulin glulisine QD and 96 in Insulin glulisine TID) were included for 2-hour glucose excursion analysis. | Mean | Standard Deviation | mmol/L |
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| Average 7-Point Self-monitored Plasma Glucose (SMPG) | 877 participants (292 in Lixisenatide arm; 291 in Insulin glulisine QD and 294 in Insulin glulisine TID) were included for average 7-point SMPG analysis. | Mean | Standard Deviation | mmol/L |
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| Insulin Glargine Dose | 893 participants (298 in Lixisenatide arm; 298 in Insulin glulisine QD and 297 in Insulin glulisine TID) were included for Insulin glargine dose analysis. | Mean | Standard Deviation | Units (U) |
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| Duration of Diabetes | Mean | Standard Deviation | years |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in HbA1c From Baseline to Week 26 | Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period. | modified intent-to-treat (mITT) population: all randomized participants who received at least one dose of study drug; and had both baseline and at least one post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. | Posted | Least Squares Mean | Standard Error | percentage of hemoglobin | Baseline, Week 26 |
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| Primary | Change in Body Weight From Baseline to Week 26 | Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID. Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. | mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period. | Posted | Least Squares Mean | Standard Error | kg | Baseline, Week 26 |
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| Secondary | Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26 | The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Missing data was imputed using LOCF. | mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Percentage of Participants With no Weight Gain at Week 26 | The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 3 days after the last dose of study drug. | mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Change in Average 7-point SMPG Profiles From Baseline to Week 26 | Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. | mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 26 |
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| Secondary | Change in FPG From Baseline to Week 26 | Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. | mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 26 |
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| Secondary | Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast) | The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. | mITT population. Here, number of participants analyzed = participants with IMP injection before breakfast and baseline and at least one post-baseline 2-hour PPG assessment during on-treatment period. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 26 |
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| Secondary | Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast) | Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change in glucose excursions was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. | mITT population. Here, number of participants analyzed = participants with IMP injection before breakfast and baseline and at least one post-baseline glucose excursion assessment during on-treatment period. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 26 |
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| Secondary | Change in Insulin Glargine Dose From Baseline to Week 26 | Change in Insulin glargine dose was calculated by subtracting the baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. | mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline insulin glargine dose assessment during on-treatment period. | Posted | Least Squares Mean | Standard Error | U | Baseline, Week 26 |
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| Secondary | Insulin Glulisine Dose at Week 26 | The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF. | mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline insulin glulisine dose assessment during on-treatment period. | Posted | Mean | Standard Deviation | U | Week 26 |
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| Secondary | Total Insulin Dose at Week 26 | The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF. The outcome is reporting results of total insulin (amounts of Insulin Glargine plus Insulin Glulisine ) only for the arms in which Insulin Glulisine was administered and is not applicable for the lixisenatide arm in which only Insulin Glargine is administered. Change in dose of the insulin used by patients in the Lixisenatide arm (i.e. Insulin Glargine) is reported in the secondary Outcome Measure 9. | mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline total insulin dose assessment during on-treatment period. | Posted | Mean | Standard Deviation | U | Week 26 |
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| Secondary | Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia | Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <60 mg/dL (3.3 mmol/L). Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available. | All randomized participants who were exposed to at least one dose of study drug, regardless of the amount of treatment administered. The 4 participants in the TID group who received Insulin Glulisine QD were analyzed according to the QD dose.The 1 participant in the QD group who received Insulin Glulisine TID was analyzed according to the TID dose | Posted | Number | percentage of participants | First dose of study drug up to 3 days after the last dose administration (maximum of 185 days) |
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| Secondary | Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period | The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. | mITT population. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26 | The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. | mITT population. Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response. Otherwise, they were counted as missing data. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period | The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. Participants without post-baseline on-treatment values (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response, or if they experienced at least one documented symptomatic hypoglycemia during the on-treatment period. Otherwise, they were counted as missing data. | mITT population.Participants without post-baseline on-treatment values(HbA1c;body weight),no more than 30 days apart counted as non-responders if at least one of components(HbA1c;body weight) was available,showed non-response or experienced at least one symptomatic hypoglycemia during on-treatment period.Otherwise,they were counted as missing data. | Posted | Number | percentage of participants | Week 26 |
|
All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 185) regardless of seriousness or relationship to IMP.
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the first dose of study drug up to 3 days after the last dose of study drug). Analysis was done on safety population.
4 participants randomized to TID group, but received insulin glulisine QD were analyzed according to the QD dose. 1 participant randomized to QD group, but received insulin glulisine TID was analyzed according to the TID dose.
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 | Lixisenatide | Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin (Median exposure of 182 days). | 11 | 298 | 183 | 298 | ||
| EG001 | Insulin Glulisine QD | Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin (Median exposure of 182 days). | 11 | 301 | 186 | 301 | ||
| EG002 | Insulin Glulisine TID | Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin (Median exposure of 182 days). | 14 | 294 | 195 | 294 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erysipelas | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Penile infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Septic arthritis staphylococcal | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Neuritis cranial | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Epigastric discomfort | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Hepatic mass | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
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| Diabetic bullosis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Skin ulcer haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Blood glucose decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 17.1 | 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 | 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 |
|---|---|
| C479460 | lixisenatide |
| D000069036 | Insulin Glargine |
| D008687 | Metformin |
| 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 |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
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| Black |
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| Asian/Oriental |
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| Other |
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| Non-Hispanic |
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| No |
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| ≥30 kg/m^2 |
|
| Participants not analyzed for BMI |
|
Pre-specified non-inferiority margin of 0.4%.
| Analysis was performed using ANCOVA model as described above. Hochberg procedure was used to control type 1 error at significance level = 0.025 (1-sided) for comparison between Lixisenatide vs Insulin glulisine TID in HbA1c and body weight. If both comparisons were met, then both would be declared significant. Otherwise, if only one was met, then the one met should be tested at α=0.0125 (1-sided). | ANCOVA | LS Mean Difference | 0.21 | Standard Error of the Mean | 0.059 | 2-Sided | 95 | 0.095 | 0.328 | Lixisenatide vs Insulin Glulisine TID | Yes | Non-Inferiority or Equivalence | Pre-specified non-inferiority margin of 0.4%. |
| Units | Counts |
|---|---|
| Participants |
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| Participants |
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| Participants |
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Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Units | Counts |
|---|
| Participants |
|
|
|
|
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| OG002 | Insulin Glulisine TID | Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin. |
|
|
|
|
|
|
| OG001 | Insulin Glulisine QD | Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin. |
| OG002 | Insulin Glulisine TID | Insulin glulisine TID SC up to Week 26 on top of insulin glargine with or without metformin. |
|
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