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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004850-32 | |||
| U1111-1168-4639 | Other Identifier | UTN |
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Primary Objective:
To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change.
Secondary Objectives:
To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 [SGLT2] inhibitor) in participants with type 2 diabetes.
To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.
The maximum duration for GLP1-RA participants was approximately 29 weeks: up to 2 week screening period, a 26 week treatment period (either randomized or uncontrolled), and a 3 or 9 day post-treatment safety follow-up period.
Maximum duration for FRC participants was approximately 55 weeks: up to 2-week screening period, a 26-week randomized treatment period, a 26-week extension period and a 3-day post-treatment safety follow-up period.
All primary and secondary efficacy, safety and other outcome measures were assessed at the end of the extension period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | Experimental | Core period: FRC injected subcutaneously once daily (QD) for 26 weeks on top of oral anti-diabetic drug (OAD) therapy. Dose individually adjusted. Single arm extension period: Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted. |
|
| GLP-1 Receptor Agonist | Active Comparator | Core period: GLP-1 RA receptor agonist (liraglutide QD, exenatide twice daily [BID], exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin glargine/lixisenatide fixed ratio combination | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period | Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least squares (LS) mean and standard error (SE) were obtained from Mixed-effect model with repeated measures (MMRM) to account for missing data using all available post baseline data during the 26 week treatment period. | Baseline, Week 26 |
| Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period | Change in HbA1c was calculated by subtracting baseline value from Week 52 value. | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reaching HbA1c <7% or <=6.5% at Week 26: Core Period | Participants without any available HbA1c assessment at Week 26 were considered as non-responders. | Week 26 |
| Percentage of Participants Reaching HbA1c <7 % or <=6.5% at Week 52: Single Arm Extension Period |
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Inclusion criteria :
in combination with metformin (daily dose greater than equal to [>=] 1500 mg/day or maximum tolerated dose [MTD]), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening.
or
Participants who were treated with stable dose of one of the following GLP-1 receptor agonists for at least 6 months prior to screening visit (V1):
in combination with metformin (daily dose ≥1500 mg/day or MTD), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening;
-Signed written informed consent.
Exclusion criteria:
Exclusion criteria for the extension period:
The above information is not intended to contain all considerations relevant to a patient'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 8400064 | Birmingham | Alabama | 35205 | United States | ||
| Investigational Site Number 8400073 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35332216 | Derived | Kuruvilla DE, Mann JI, Tepper SJ, Starling AJ, Panza G, Johnson MAL. Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM). Sci Rep. 2022 Mar 24;12(1):5110. doi: 10.1038/s41598-022-09071-6. | |
| 35257461 | Derived | Ferrannini E, Niemoeller E, Dex T, Servera S, Mari A. Fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi) improves ss-cell function in people with type 2 diabetes. Diabetes Obes Metab. 2022 Jun;24(6):1159-1165. doi: 10.1111/dom.14688. Epub 2022 Mar 28. |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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A total of 514 participants were randomized in 1:1 (Insulin Glargine/Lixisenatide fixed ratio combination [FRC] or glucagon-like peptide-1 receptor agonist [GLP-1 RA]) ratio. Randomization was stratified by values of HbA1c at screening (<8%, >=8%) & GLP-1 RA subtype at screening (once/twice daily [QD/BID], once weekly [QW] formulations).
The study was conducted at 112 sites in 9 countries. A total of 840 participants were screened between 06 July 2016 and 01 November 2017, of which 326 were screen failures. Screen failures were mainly due to glycated hemoglobin (HbA1c) level lesser than (<)7% or more than (>)9% at screening visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | Core period: FRC injected subcutaneously QD for 26 weeks on top of oral anti-diabetic drug (OAD) therapy. Dose individually adjusted. Single arm extension period: participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Period: 26 Weeks |
|
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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 | May 12, 2017 | May 23, 2019 |
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|
| liraglutide | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
|
|
| exenatide | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
|
|
| exenatide extended-release | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
|
|
| albiglutide | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
|
|
| dulaglutide | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
|
|
| Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor) | Drug | Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study. |
|
Participants without any available HbA1c assessment at Week 52 were considered as non-responders. |
| Week 52 |
| Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26: Core Period | Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period. | Baseline, Week 26 |
| Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52: Single Arm Extension Period | Change in FPG was calculated by subtracting baseline value from Week 52 value. | Baseline, Week 52 |
| Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 26: Core Period | The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period. | Baseline, Week 26 |
| Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 52: Single Arm Extension Period | The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal. | Baseline, Week 52 |
| Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 26: Core Period | The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last observation carried forward (LOCF). | Baseline, Week 26 |
| Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 52: Single Arm Extension Period | The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF. | Baseline, Week 52 |
| Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 26: Core Period | 2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. | Baseline, Week 26 |
| Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 52: Single Arm Extension Period | 2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before IMP administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF. | Baseline, Week 52 |
| Percentage of Participants Requiring Rescue Therapy During the 26 Week Treatment Period: Core Period | Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c >8%. | From Baseline to Week 26 |
| Percentage of Participants Requiring Rescue Therapy During the 52 Week Treatment Period: Single Arm Extension Period | Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c >8%. | From Week 26 to Week 52 |
| Change From Baseline in Body Weight at Week 26: Core Period | Change in body weight was calculated by subtracting baseline value from Week 26 value. | Baseline, Week 26 |
| Change From Baseline in Body Weight to Week 52: Single Arm Extension Period | Change in body weight was calculated by subtracting baseline value from Week 52 value. | Baseline, Week 52 |
| Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Core Period | Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of <3.0 mmol/L (54 mg/dL) were also analyzed. | From Baseline to Week 26 |
| Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Single Arm Extension Period | Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of <3.0 mmol/L (54 mg/dL) were also analyzed. | From Baseline to Week 52 |
| Fountain Hills |
| Arizona |
| 85268 |
| United States |
| Investigational Site Number 8400047 | Phoenix | Arizona | 85028 | United States |
| Investigational Site Number 8400103 | Bakersfield | California | 93309 | United States |
| Investigational Site Number 8400137 | Fresno | California | 93720 | United States |
| Investigational Site Number 8400043 | Huntington Park | California | 90255 | United States |
| Investigational Site Number 8400124 | Lamont | California | 93241 | United States |
| Investigational Site Number 8400027 | Lancaster | California | 93534 | United States |
| Investigational Site Number 8400098 | Los Angeles | California | 90017 | United States |
| Investigational Site Number 8400013 | Los Angeles | California | 90057 | United States |
| Investigational Site Number 8400042 | Mission Hills | California | 91345 | United States |
| Investigational Site Number 8400006 | Northridge | California | 91325 | United States |
| Investigational Site Number 8400021 | Orange | California | 92868 | United States |
| Investigational Site Number 8400126 | Rialto | California | 92377 | United States |
| Investigational Site Number 8400094 | Santa Ana | California | 92704 | United States |
| Investigational Site Number 8400009 | Ventura | California | 93003 | United States |
| Investigational Site Number 8400071 | Denver | Colorado | 80209 | United States |
| Investigational Site Number 8400036 | Denver | Colorado | 80246 | United States |
| Investigational Site Number 8400114 | Jacksonville | Florida | 32216 | United States |
| Investigational Site Number 8400133 | Miami | Florida | 33165 | United States |
| Investigational Site Number 8400058 | Port Charlotte | Florida | 33952 | United States |
| Investigational Site Number 8400084 | Tampa | Florida | 33612 | United States |
| Investigational Site Number 8400112 | West Palm Beach | Florida | 33401 | United States |
| Investigational Site Number 8400045 | Lawrenceville | Georgia | 30046 | United States |
| Investigational Site Number 8400096 | Snellville | Georgia | 30078 | United States |
| Investigational Site Number 8400023 | Springfield | Illinois | 62711 | United States |
| Investigational Site Number 8400049 | Avon | Indiana | 46123 | United States |
| Investigational Site Number 8400053 | Avon | Indiana | 46123 | United States |
| Investigational Site Number 8400085 | Avon | Indiana | 46123 | United States |
| Investigational Site Number 8400120 | Avon | Indiana | 46123 | United States |
| Investigational Site Number 8400041 | Evansville | Indiana | 47714 | United States |
| Investigational Site Number 8400038 | Indianapolis | Indiana | 46254-5469 | United States |
| Investigational Site Number 8400130 | Council Bluffs | Iowa | 51501 | United States |
| Investigational Site Number 8400034 | Lexington | Kentucky | 40503 | United States |
| Investigational Site Number 8400091 | Lexington | Kentucky | 40503 | United States |
| Investigational Site Number 8400078 | Marrero | Louisiana | 70072 | United States |
| Investigational Site Number 8400032 | Metairie | Louisiana | 70006 | United States |
| Investigational Site Number 8400088 | New Orleans | Louisiana | 70121 | United States |
| Investigational Site Number 8400033 | Baltimore | Maryland | 21237 | United States |
| Investigational Site Number 8400051 | Jefferson City | Missouri | 65109 | United States |
| Investigational Site Number 8400083 | Papillion | Nebraska | 68046-3136 | United States |
| Investigational Site Number 8400044 | Henderson | Nevada | 89052 | United States |
| Investigational Site Number 8400079 | Albany | New York | 12206 | United States |
| Investigational Site Number 8400061 | New York | New York | 10001 | United States |
| Investigational Site Number 8400123 | North Massapequa | New York | 11758 | United States |
| Investigational Site Number 8400095 | Staten Island | New York | 10301 | United States |
| Investigational Site Number 8400067 | West Seneca | New York | 14224 | United States |
| Investigational Site Number 8400111 | Yonkers | New York | 10704 | United States |
| Investigational Site Number 8400020 | Morehead City | North Carolina | 28557 | United States |
| Investigational Site Number 8400065 | Wilmington | North Carolina | 28401 | United States |
| Investigational Site Number 8400018 | Fargo | North Dakota | 58104 | United States |
| Investigational Site Number 8400019 | Columbus | Ohio | 43201 | United States |
| Investigational Site Number 8400056 | Dayton | Ohio | 45439 | United States |
| Investigational Site Number 8400125 | Mentor | Ohio | 44060 | United States |
| Investigational Site Number 8400099 | Oklahoma City | Oklahoma | 73112 | United States |
| Investigational Site Number 8400129 | Scottdale | Pennsylvania | 15683 | United States |
| Investigational Site Number 8400076 | Smithfield | Pennsylvania | 15478 | United States |
| Investigational Site Number 8400104 | Warwick | Rhode Island | 02886 | United States |
| Investigational Site Number 8400090 | Columbia | South Carolina | 29204 | United States |
| Investigational Site Number 8400139 | Austin | Texas | 78749 | United States |
| Investigational Site Number 8400001 | Dallas | Texas | 75230-6885 | United States |
| Investigational Site Number 8400118 | Edinburg | Texas | 78539 | United States |
| Investigational Site Number 8400008 | Houston | Texas | 77004 | United States |
| Investigational Site Number 8400109 | Houston | Texas | 77040 | United States |
| Investigational Site Number 8400063 | Houston | Texas | 77061 | United States |
| Investigational Site Number 8400106 | Houston | Texas | 77081 | United States |
| Investigational Site Number 8400014 | North Richland Hills | Texas | 76180 | United States |
| Investigational Site Number 8400089 | San Antonio | Texas | 78240 | United States |
| Investigational Site Number 8400135 | Schertz | Texas | 78154 | United States |
| Investigational Site Number 8400075 | Shavano Park | Texas | 78231 | United States |
| Investigational Site Number 8400107 | Sugar Land | Texas | 77478 | United States |
| Investigational Site Number 8400054 | Orem | Utah | 84058 | United States |
| Investigational Site Number 8400025 | Salt Lake City | Utah | 84102 | United States |
| Investigational Site Number 8400092 | Weber City | Virginia | 24290 | United States |
| Investigational Site Number 1240003 | Burlington | L7M 4Y1 | Canada |
| Investigational Site Number 1240006 | Corunna | N0N 1G0 | Canada |
| Investigational Site Number 1240002 | Red Deer | T4N 6V7 | Canada |
| Investigational Site Number 1240001 | Vancouver | V5Y 3W2 | Canada |
| Investigational Site Number 2330002 | Pärnu | 80018 | Estonia |
| Investigational Site Number 2330003 | Tallinn | 10138 | Estonia |
| Investigational Site Number 2330001 | Tallinn | 13419 | Estonia |
| Investigational Site Number 2330004 | Viljandi | 71024 | Estonia |
| Investigational Site Number 2760001 | Dresden | 01307 | Germany |
| Investigational Site Number 2760003 | Oldenburg in Holstein | 23758 | Germany |
| Investigational Site Number 3760001 | Haifa | 31096 | Israel |
| Investigational Site Number 3760002 | Haifa | 35152 | Israel |
| Investigational Site Number 3760005 | Jerusalem | 91120 | Israel |
| Investigational Site Number 3760006 | Jerusalem | 93106 | Israel |
| Investigational Site Number 3760004 | Tel Aviv | 6203854 | Israel |
| Investigational Site Number 3800008 | Bergamo | 24127 | Italy |
| Investigational Site Number 3800002 | Bologna | 40138 | Italy |
| Investigational Site Number 3800001 | Milan | 20132 | Italy |
| Investigational Site Number 3800006 | Milan | 20142 | Italy |
| Investigational Site Number 3800005 | Naples | 80131 | Italy |
| Investigational Site Number 3800004 | Roma | 00128 | Italy |
| Investigational Site Number 3800003 | Roma | 00133 | Italy |
| Investigational Site Number 6420004 | Bacau | 600154 | Romania |
| Investigational Site Number 6420006 | Brasov | 500097 | Romania |
| Investigational Site Number 6420001 | Bucharest | 020045 | Romania |
| Investigational Site Number 6420008 | Buzău | 120203 | Romania |
| Investigational Site Number 6420003 | Cluj-Napoca | 400006 | Romania |
| Investigational Site Number 6420002 | Oradea | 410159 | Romania |
| Investigational Site Number 6420009 | Targoviste | 130083 | Romania |
| Investigational Site Number 6420007 | Târgu Mureş | 540098 | Romania |
| Investigational Site Number 6420005 | Timișoara | 300125 | Romania |
| Investigational Site Number 7030006 | Bratislava | 85101 | Slovakia |
| Investigational Site Number 7030002 | Lučenec | 98401 | Slovakia |
| Investigational Site Number 7030009 | Ľubochňa | 034 91 | Slovakia |
| Investigational Site Number 7030005 | Malacky | 90101 | Slovakia |
| Investigational Site Number 7030007 | Prešov | 08001 | Slovakia |
| Investigational Site Number 7030001 | Rožňava | 04801 | Slovakia |
| Investigational Site Number 7030008 | Sabinov | 083 01 | Slovakia |
| Investigational Site Number 7030004 | Trenčín | 91101 | Slovakia |
| Investigational Site Number 7030003 | Žilina | 010 01 | Slovakia |
| Investigational Site Number 7240012 | Alzira | 46600 | Spain |
| Investigational Site Number 7240005 | Barcelona | 08035 | Spain |
| Investigational Site Number 7240002 | Ferrol | 15405 | Spain |
| Investigational Site Number 7240008 | Málaga | 29010 | Spain |
| Investigational Site Number 7240011 | Pozuelo de Alarcón | 28223 | Spain |
| Investigational Site Number 7240003 | Quart de Poblet | 46930 | Spain |
| Investigational Site Number 7240006 | Sabadell | 08208 | Spain |
| Investigational Site Number 7240007 | Seville | 41003 | Spain |
| Investigational Site Number 7240009 | Seville | 41010 | Spain |
| Investigational Site Number 7240004 | Seville | 41071 | Spain |
| 34894329 | Derived | Guja C, Giorgino F, Blonde L, Ali A, Prazny M, Meier JJ, Souhami E, Lubwama R, Ji C, Rosenstock J. Concomitant iGlarLixi and Sodium-Glucose Co-transporter-2 Inhibitor Therapy in Adults with Type 2 Diabetes: LixiLan-G Trial and Real-World Evidence Results. Diabetes Ther. 2022 Jan;13(1):205-215. doi: 10.1007/s13300-021-01180-1. Epub 2021 Dec 11. |
| 33468520 | Derived | Blonde L, Rosenstock J, Frias J, Birkenfeld AL, Niemoeller E, Souhami E, Ji C, Del Prato S, Aroda VR. Durable Effects of iGlarLixi Up to 52 Weeks in Type 2 Diabetes: The LixiLan-G Extension Study. Diabetes Care. 2021 Mar;44(3):774-780. doi: 10.2337/dc20-2023. Epub 2021 Jan 19. |
| 31530665 | Derived | Blonde L, Rosenstock J, Del Prato S, Henry R, Shehadeh N, Frias J, Niemoeller E, Souhami E, Ji C, Aroda VR. Switching to iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA in Type 2 Diabetes Inadequately Controlled by GLP-1 RA and Oral Antihyperglycemic Therapy: The LixiLan-G Randomized Clinical Trial. Diabetes Care. 2019 Nov;42(11):2108-2116. doi: 10.2337/dc19-1357. Epub 2019 Sep 17. |
| FG001 | GLP-1 Receptor Agonist | Core Period: GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| Extension Period:26 Weeks(Upto 52 Weeks) |
|
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Analysis was performed on randomized population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | FRC injected subcutaneously QD for 26 weeks on top of OAD therapy. Dose individually adjusted. |
| BG001 | GLP-1 Receptor Agonist | GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Body Mass Index (BMI) | Count of Participants | Participants |
| ||||||||||||||||
| Duration of diabetes | Mean | Standard Deviation | years |
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| Hemoglobin A1C (HbA1C) | Mean | Standard Deviation | percentage of HbA1c |
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| Daily dose of metformin at baseline | Mean | Standard Deviation | milligrams (mg) |
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| Daily dose of pioglitazone at baseline | Here, number analyzed=number of participants with available data for specified measure. | Mean | Standard Deviation | mg |
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| Daily dose of SGLT2 inhibitor at baseline | Here, number analyzed=number of participants with available data for specified categories. | Mean | Standard Deviation | mg |
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| Duration of GLP-1 receptor agonist treatment | Mean | Standard Deviation | years |
| |||||||||||||||
| GLP-1 receptor agonist use by type at screening | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period | Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least squares (LS) mean and standard error (SE) were obtained from Mixed-effect model with repeated measures (MMRM) to account for missing data using all available post baseline data during the 26 week treatment period. | Modified Intent-To-Treat (mITT) population:all randomized participants who had a baseline and at least 1 post-baseline assessment of any primary/secondary outcome measures, irrespective of compliance with study protocol and procedures."Overall number of participants analyzed"=participants with baseline and at least 1 post-baseline HbA1c assessment. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline, Week 26 |
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| Primary | Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period | Change in HbA1c was calculated by subtracting baseline value from Week 52 value. | Analysis was performed on mITT population who entered the extension period. Here, "Overall number of participants analyzed" = participants with baseline and at least 1 post-baseline HbA1c assessment. | Posted | Mean | Standard Error | percentage of HbA1c | Baseline, Week 52 |
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| Secondary | Percentage of Participants Reaching HbA1c <7% or <=6.5% at Week 26: Core Period | Participants without any available HbA1c assessment at Week 26 were considered as non-responders. | Analysis was performed on mITT population. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Percentage of Participants Reaching HbA1c <7 % or <=6.5% at Week 52: Single Arm Extension Period | Participants without any available HbA1c assessment at Week 52 were considered as non-responders. | Analysis was performed on mITT population who entered the extension period. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26: Core Period | Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period. | Analysis was performed using mITT population. Here, "overall number of participants analyzed" = participants with baseline and at least one post-baseline FPG assessment. | Posted | Least Squares Mean | Standard Error | millimoles per litre (mmol/L) | Baseline, Week 26 |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52: Single Arm Extension Period | Change in FPG was calculated by subtracting baseline value from Week 52 value. | Analysis was performed on mITT population who entered the extension period. Here, "overall number of participants analyzed" = participants with baseline and at least one post-baseline FPG assessment. | Posted | Mean | Standard Error | mmol/L | Baseline, Week 52 |
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| Secondary | Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 26: Core Period | The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period. | Analysis was performed using mITT population. Here, "overall number of participants analyzed" = participants with baseline and at least one post-baseline 7-point SMPG assessment. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 26 |
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| Secondary | Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 52: Single Arm Extension Period | The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal. | Analysis was performed on mITT population who entered the extension period. Here, "overall number of participants analyzed" = participants with baseline and at least one post-baseline 7-point SMPG assessment. | Posted | Mean | Standard Error | mmol/L | Baseline, Week 52 |
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| Secondary | Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 26: Core Period | The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last observation carried forward (LOCF). | Analysis was performed on mITT population. Here, "overall number of participants analyzed" = participants with baseline and at least one post-baseline plasma glucose assessment. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 26 |
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| Secondary | Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 52: Single Arm Extension Period | The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF. | Analysis was performed on mITT population who entered the extension period. Here, "overall number of participants analyzed" = participants with baseline and at least one post-baseline plasma glucose assessment. | Posted | Mean | Standard Error | mmol/L | Baseline, Week 52 |
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| Secondary | Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 26: Core Period | 2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. | Analysis was performed using mITT population. Here, "overall number of participants analyzed" = participants with baseline and Week 26 assessments. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 26 |
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| Secondary | Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 52: Single Arm Extension Period | 2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before IMP administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF. | Analysis was performed on mITT population who entered the extension period. Here, "overall number of participants analyzed" = participants with baseline and Week 52 assessments. | Posted | Mean | Standard Error | mmol/L | Baseline, Week 52 |
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| Secondary | Percentage of Participants Requiring Rescue Therapy During the 26 Week Treatment Period: Core Period | Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c >8%. | Analysis was performed using mITT population. | Posted | Number | percentage of participants | From Baseline to Week 26 |
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| Secondary | Percentage of Participants Requiring Rescue Therapy During the 52 Week Treatment Period: Single Arm Extension Period | Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c >8%. | Analysis was performed on mITT population who entered the extension period. | Posted | Number | percentage of participants | From Week 26 to Week 52 |
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| Secondary | Change From Baseline in Body Weight at Week 26: Core Period | Change in body weight was calculated by subtracting baseline value from Week 26 value. | Analysis was performed using mITT population. Here, "overall number of participants analyzed" = participants with baseline and at least one post-baseline body weight assessment. | Posted | Least Squares Mean | Standard Error | kilogram (kg) | Baseline, Week 26 |
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| Secondary | Change From Baseline in Body Weight to Week 52: Single Arm Extension Period | Change in body weight was calculated by subtracting baseline value from Week 52 value. | Analysis was performed using mITT population who entered the extension period. Here, "overall number of participants analyzed" = participants with baseline and at least one post-baseline body weight assessment. | Posted | Mean | Standard Error | kg | Baseline, Week 52 |
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| Secondary | Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Core Period | Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of <3.0 mmol/L (54 mg/dL) were also analyzed. | Analysis was performed on safety population which included all randomized participants who received at least one dose of open-label IMP, regardless of the amount of treatment administered. Participants were analyzed according to the treatment actually received (as treated). | Posted | Number | events per participant-year | From Baseline to Week 26 |
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| Secondary | Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Single Arm Extension Period | Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of <3.0 mmol/L (54 mg/dL) were also analyzed. | Analysis was performed on safety population who entered the extension period and their data for whole study duration was analyzed and reported. | Posted | Number | events per participant-year | From Baseline to Week 52 |
|
|
All Adverse Events (AEs) were collected from signature of informed consent until the end of the study (up to 52 weeks).
Reported AEs are treatment-emergent that is AEs that developed/worsened during during the period from the administration of first dose of the study treatments up to 3 days (9 days for the weekly GLP1) after the last administration. 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 | Fixed Ratio Combination | FRC injected subcutaneously QD for 26 weeks on top of OAD therapy. Dose individually adjusted (median exposure: 183 days). | 0 | 255 | 10 | 255 | 69 | 255 |
| EG001 | GLP-1 Receptor Agonist | GLP-1 RA receptor agonist (liraglutide QD, exenatide BID, exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization (median exposure: 183 days). | 0 | 256 | 9 | 256 | 48 | 256 |
| EG002 | Fixed Ratio Combination Whole Study Period | Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted (median exposure: 365 days). | 1 | 206 | 21 | 206 | 75 | 206 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis Coronary Artery | Cardiac disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Ischaemic Cardiomyopathy | Cardiac disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Duodenal Ulcer | Gastrointestinal disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Large Intestine Polyp | Gastrointestinal disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Infected Skin Ulcer | Infections and infestations | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Postoperative Abscess | Infections and infestations | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Subarachnoid Haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Subcutaneous Haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Electrolyte Imbalance | Metabolism and nutrition disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Adenosquamous Cell Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Bladder Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Endometrial Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Hepatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Invasive Ductal Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Papillary Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Cerebral Infarction | Nervous system disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Diabetic Neuropathy | Nervous system disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Hypoglycaemic Unconsciousness | Nervous system disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Intraventricular Haemorrhage | Nervous system disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Dermal Cyst | Skin and subcutaneous tissue disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Vasculitis Necrotising | Vascular disorders | MedDRA 21.0 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 21.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 21.0 21.1 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 1# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 7, 2017 | May 23, 2019 | 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 |
| C479460 | lixisenatide |
| D000069450 | Liraglutide |
| D000077270 | Exenatide |
| C534611 | rGLP-1 protein |
| C555680 | dulaglutide |
| D008687 | Metformin |
| D000077205 | Pioglitazone |
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| 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 |
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |
Not provided
Not provided
| Other than specified |
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| Asian/Oriental |
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| Black |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Unknown or Not Reported' |
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| >=30 |
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| Empagliflozin |
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| Dapagliflozin |
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| Once weekly formulation |
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| Superiority |
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