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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001922-14 | EudraCT Number |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin low dose | Experimental | Empagliflozin tablets once daily |
|
| Empagliflozin high dose | Experimental | Empagliflozin tablets once daily |
|
| Placebo | Placebo Comparator | Placebo tablets matching empagliflozin once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug |
| ||
| Empagliflozin |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 | Change from baseline in glycated haemoglobin (HbA1c) for full analysis set (FAS) (observed cases [OC]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects. | Baseline to week 26 |
| Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD) ) | Change from baseline in glycated haemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data [OC-AD]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects. | Baseline to week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycaemia Adverse Events (AEs) With Confirmed Plasma Glucose (PG) | This is a key secondary endpoint. Rate per patient-year of investigator-reported symptomatic hypoglycaemia adverse events (AEs) with confirmed plasma glucose (PG) <54 milligram per deciliter (mg/dL) (<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycaemia AEs (i.e. all investigator-reported AEs that had confirmed PG <54 mg/dL [<3.0 mmol/L] with symptoms reported and all severe hypoglycaemia events that were confirmed by adjudication) is presented for (i) From week 5 to 26 and (ii) From week 1 to 26. Least squares mean is actually an adjusted event rate. |
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Inclusion criteria:
Male or female patient receiving insulin for the treatment of documented diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 1 year at the time of Visit 1
Fasting C-peptide value of < 0.7 ng/mL (0.23 nmol/L) at Visit 2 measured by the central laboratory
Use of, and be willing, based on the Investigator's judgement, to continue throughout the duration of the trial, either:
HbA1c >/= 7.5% and </= 10.0% at Visit 5 measured by the central laboratory
Age >/= 18 years at Visit 1
Additional inclusion criteria may apply
Exclusion criteria:
Additional exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute, Inc. | Escondido | California | 92025 | United States | ||
| Diabetes/Lipid Management and Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37616393 | Derived | Song C, Dhaliwal S, Bapat P, Scarr D, Bakhsh A, Budhram D, Verhoeff NJ, Weisman A, Fralick M, Ivers NM, Cherney DZI, Tomlinson G, Lovblom LE, Mumford D, Perkins BA. Point-of-Care Capillary Blood Ketone Measurements and the Prediction of Future Ketoacidosis Risk in Type 1 Diabetes. Diabetes Care. 2023 Nov 1;46(11):1973-1977. doi: 10.2337/dc23-0840. | |
| 30287422 |
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Not provided
6-week T1DM therapy (insulin) optimisation period followed by a 2-week placebo run-in period before randomisation. Patients who successfully completed both of the periods were randomised into the 52-week double-blind treatment period. All treatments were administered in addition to optimised insulin therapy.
Randomised, double-blind, placebo-controlled, parallel group, 52-week trial comparing 2 oral once daily doses (10 mg and 25 mg) of empagliflozin with placebo in patients with type 1 diabetes mellitus (T1DM), each as adjunctive to optimised insulin therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Matching Empagliflozin | Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks |
| FG001 | Empagliflozin 10 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 4, 2017 | Oct 21, 2018 |
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|
| Placebo | Drug |
|
| Week 5 to Week 26, Week 1 to Week 26 |
| Change From Baseline in Body Weight at Week 26 | Change from baseline in body weight is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. | Baseline to week 26 |
| Change From Baseline in Percentage of Time Spent in Target Glucose Range From Weeks 23 to 26 | Change from baseline in the percentage of time spent in target glucose range of >70 to ≤180 mg/dL (>3.9 to ≤10.0 mmol/L) as determined by continuous glucose monitoring (CGM) is presented in week 23 to 26. Least squares mean is actually an adjusted event rate. | Week 23 to 26 |
| Change From Baseline in Interstitial Glucose Variability Based on the Interquartile Range (IQR) as Determined by CGM in Weeks 23 to 26 | Change from baseline in interstitial glucose variability based on the IQR as determined by CGM is presented for week 23 to 26. Least squares mean is actually an adjusted event rate. | Week 23 to 26 |
| Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26 | Change from baseline in TDID is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. | Baseline to week 26 |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26 | Change from baseline in SBP and DBP is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. | Baseline to week 26 |
| Huntington Beach |
| California |
| 92648 |
| United States |
| National Research Institute | Los Angeles | California | 90057 | United States |
| Mills-Peninsula Health Services | San Mateo | California | 94401 | United States |
| Metabolic Institute of America | Tarzana | California | 91356 | United States |
| University Clinical Investigators, Inc. | Tustin | California | 92780 | United States |
| Creekside Endocrine Associates, PC | Denver | Colorado | 80246 | United States |
| The Center for Diabetes and Endocrine Care | Fort Lauderdale | Florida | 33312 | United States |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32204 | United States |
| Baptist Diabetes Associates, PA | Miami | Florida | 33156 | United States |
| Physicians Research Associates, LLC | Lawrenceville | Georgia | 30046 | United States |
| Endocrine Research Solutions, Inc. | Roswell | Georgia | 30076 | United States |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
| Northwest Endo Diabetes Research, LLC | Arlington Heights | Illinois | 60005 | United States |
| Midwest Endocrinology | Crystal Lake | Illinois | 60012 | United States |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50265 | United States |
| Diabetes anddocrine Associates, PC | Omaha | Nebraska | 68114 | United States |
| Desert Endocrinology Clinical Research Center | Henderson | Nevada | 89052 | United States |
| Palm Research Center | Las Vegas | Nevada | 89148 | United States |
| Southern New Hampshire Diabetes and Endocrinology | Nashua | New Hampshire | 03063 | United States |
| Albany Medical Center / Albany Medical College | Albany | New York | 12206 | United States |
| University Physicians Group Research Division | Staten Island | New York | 10301 | United States |
| Diabetes and Endocrinology Consultants, PC | Morehead City | North Carolina | 28557 | United States |
| The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Diabetes and Obesity Clinical Trials Center | Nashville | Tennessee | 37212 | United States |
| North Texas Endocrine Center | Dallas | Texas | 75231 | United States |
| Office of Dr. Michelle Zaniewski-Singh | Houston | Texas | 77090 | United States |
| Texas Diabetes and Endocrinology | Round Rock | Texas | 78681 | United States |
| Bateman Horne Center | Salt Lake City | Utah | 84102 | United States |
| Advanced Research Institute | South Ogden | Utah | 84405 | United States |
| Larry D Stonesifer, MD Inc., PS | Federal Way | Washington | 98003 | United States |
| Rainier Clinical Research Center, Inc | Renton | Washington | 98057 | United States |
| The Polyclinic | Seattle | Washington | 98104 | United States |
| MultiCare Institute for Research and Innovation | Tacoma | Washington | 98405 | United States |
| Coffs Endocrine & Diabetes Services | Coffs Harbour | New South Wales | 2450 | Australia |
| AIM Centre | Merewether | New South Wales | 2291 | Australia |
| Royal Brisbane & Women's Hospital-Endocrinology | Herston | Queensland | 4006 | Australia |
| VIVIT Instit.am LKH Feldkirch,Abt.f.Innere Med.u.Kardiologie | Feldkirch | 6807 | Austria |
| LKH Steyr, Kardiologie | Steyr | 4400 | Austria |
| KH Rudolfstiftung, 1. Med. Abt., Wien | Vienna | 1030 | Austria |
| Hospital Hietzing | Vienna | 1130 | Austria |
| Arlon - HOSP Sud Luxembourg - Vivalia | Arlon | 6700 | Belgium |
| Bonheiden - HOSP Imelda | Bonheiden | 2820 | Belgium |
| ULB Hopital Erasme | Brussels | 1070 | Belgium |
| Brussels - UNIV UZ Brussel | Brussels | 1090 | Belgium |
| Edegem - UNIV UZ Antwerpen | Edegem | 2650 | Belgium |
| UNIV UZ Gent | Ghent | 9000 | Belgium |
| La Louvière - UNIV CHU Tivoli | La Louvière | 7100 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Centre Hospitalier Universitaire de Liège | Liège | 4000 | Belgium |
| Liège - HOSP CHR de la Citadelle | Liège | 4000 | Belgium |
| Merksem - HOSP ZNA Jan Palfijn | Merksem | 2170 | Belgium |
| LMC Endocrinology Centres (Calgary) Ltd. | Calgary | Alberta | T2H 2G4 | Canada |
| The Bailey Clinic | Red Deer | Alberta | T4N 6V7 | Canada |
| Royal Jubilee Hospital | Victoria | British Columbia | V8R 1J8 | Canada |
| Health Sciences Centre Winnipeg | Winnipeg | Manitoba | R3E 3P4 | Canada |
| CHUM - Pavillon R | Montreal | Migration Data | Quebec | Canada |
| Capital District Health Auth. | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| LMC Thornhill/Vaughan | Thornhill | Ontario | L4J 8L7 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5T 3L9 | Canada |
| Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada |
| General Univ.hosp.in Prague (VFN), Diabetes ambulance | Prague | 128 08 | Czechia |
| Diabetology and Internal Practice Dr. Vladimir Lelek | Slaný | 274 01 | Czechia |
| Masaryk Hospital, Internal Department | Ústí nad Labem | 401 13 | Czechia |
| Aalborg Sygehus Syd | Aalborg | 9100 | Denmark |
| Aarhus Universitets Hospital | Aarhus C | 8000 | Denmark |
| Steno Diabetes Center Copenhagen | Gentofte Municipality | 2820 | Denmark |
| Nordsjællands Hospital - Hillerød | Hillerød | 3400 | Denmark |
| Køge Sygehus | Køge | 4600 | Denmark |
| IteLasaretti | Kuopio | FI-70100 | Finland |
| Terveystalo Oulu, Diapolis | Oulu | FI-90100 | Finland |
| TYKS | Turku | FI-20520 | Finland |
| HOP Côte de Nacre | Caen | 14033 | France |
| HOP Saint-Louis | La Rochelle | 17000 | France |
| HOP de Narbonne, diabéto endo, Narbonne | Narbonne | 11100 | France |
| HOP Robert Debré | Reims | 51092 | France |
| HOP de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| HOP les Portes du Sud, Diabéto, Vénissieux | Vénissieux | 69200 | France |
| Studienzentrum Aschaffenburg | Aschaffenburg | 63739 | Germany |
| Gemeinschaftspraxis, Asslar | Aßlar | 35614 | Germany |
| ikfe - Institut für klinische Forschung und Entwicklung Berlin GmbH | Berlin | 10115 | Germany |
| InnoDiab Forschung GmbH | Essen | 45136 | Germany |
| Praxis Dr. Kosch, Pirna | Pirna | 01796 | Germany |
| Allgemeinmedizinische und Diabetologische Schwerpunktpraxis | Rehlingen-Siersburg | 66780 | Germany |
| Praxis Dr. Hirschhäuser | Saarbrücken | 66121 | Germany |
| Praxis Dr. Segner, St. Ingbert | Saint Ingbert/Oberwürzbach | 66386 | Germany |
| Ambulanzzentrum Schweinfurt | Schweinfurt | 97421 | Germany |
| Noordwest Ziekenhuisgroep | Alkmaar | 1815 JD | Netherlands |
| Academisch Medisch Centrum (AMC) | Amsterdam | 1105 AZ | Netherlands |
| Rijnstate Hospital | Arnhem | 6815 AD | Netherlands |
| Martini Ziekenhuis | Groningen | 9728 NT | Netherlands |
| Bethesda Ziekenhuis Hoogeveen | Hoogeveen | 7909 AA | Netherlands |
| Sint Franciscus Gasthuis | Rotterdam | 3045 PM | Netherlands |
| Albert Schweitzer Ziekenhuis, Zwijndrecht | Zwijndrecht | 3331 LZ | Netherlands |
| Helse Møre og Romsdal HF, Ålesund sjukehus | Ålesund | N-6026 | Norway |
| Sykehuset Innlandet HF, Avd. Hamar | Hamar | N-2318 | Norway |
| Akershus Universitetssykehus HF | Lørenskog | N-1478 | Norway |
| Oslo Universitetssykehus HF, Aker Sykehus | Oslo | N-0424 | Norway |
| Med Univ Bialystok Clin Dep Endocrinol, Diabetol & Int Dis | Bialystok | 15-276 | Poland |
| NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny | Bialystok | 15-435 | Poland |
| Dobry Lekarz,Spec.Med.Clinics,Private Prac,Krakow | Krakow | 31011 | Poland |
| NZOZ Specialized Ambulance "MEDICA" | Lublin | 20-538 | Poland |
| Marcinkowski Poznan Univ of Med Sci, Clin Dept Diab, Poznan | Poznan | 60-834 | Poland |
| NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom | Radom | 26610 | Poland |
| Centrum Medyczne Medyk | Rzeszów | 35-055 | Poland |
| NBR Polska | Warsaw | 00-465 | Poland |
| C.A.P. Sardenya | Barcelona | 08025 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital de la Inmaculada Concepción | Granada | 18004 | Spain |
| Hospital Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital General de Segovia | Segovia | 40002 | Spain |
| Hospital Nuestra Señora de Valme | Seville | 41014 | Spain |
| Hospital Virgen Macarena | Seville | 41071 | Spain |
| Ladulaas Kliniska Studier | Borås | 506 30 | Sweden |
| Centralsjukhuset, Karlstad | Karlstad | 651 85 | Sweden |
| Läkarhuset, Vällingby | Vällingby | 162 68 | Sweden |
| Chung Shan Medical University Hospital | Taichung | 402 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Chi Mei Medical Center | Tainan | 710 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Tri-Service General Hospital | Taipei | 11490 | Taiwan |
| Milton Keynes Hospital | Buckinghamshire | MK65LD | United Kingdom |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Wellcome Trust Clinical Research Facility | Edinburgh | EH4 2XU | United Kingdom |
| Leicester General Hospital | Leicester | LE5 4PW | United Kingdom |
| Royal London Hospital | London | E1 1BB | United Kingdom |
| Queen's Medical Centre | Nottingham | NG7 2UH | United Kingdom |
| George Eliot Hospital | Nuneaton | CV10 7DJ | United Kingdom |
| East Surrey Hospital | Surrey | RH1 5RH | United Kingdom |
| Queen Elizabeth II Hospital | Welwyn Garden City | AL7 4HQ | United Kingdom |
| Rosenstock J, Marquard J, Laffel LM, Neubacher D, Kaspers S, Cherney DZ, Zinman B, Skyler JS, George J, Soleymanlou N, Perkins BA. Empagliflozin as Adjunctive to Insulin Therapy in Type 1 Diabetes: The EASE Trials. Diabetes Care. 2018 Dec;41(12):2560-2569. doi: 10.2337/dc18-1749. Epub 2018 Oct 4. |
Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
| FG002 | Empagliflozin 25 mg | Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomised set (RS): All patients from the screened set (SCR) who were randomised to trial medication regardless of whether any trial medication was taken.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Matching Empagliflozin | Patients administered placebo matching empagliflozin film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks |
| BG001 | Empagliflozin 10 mg | Patients administered empagliflozin 10 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks. |
| BG002 | Empagliflozin 25 mg | Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks. |
| 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 | RS | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | RS | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | RS | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | RS | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 | Change from baseline in glycated haemoglobin (HbA1c) for full analysis set (FAS) (observed cases [OC]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects. | Full analysis set (FAS) (observed cases [OC]): Patients in the Treated Set (TS) who had a baseline and at least 1 on-treatment HbA1c measurement; the FAS was the basis for the primary efficacy analysis | Posted | Least Squares Mean | Standard Error | Percentage (%) | Baseline to week 26 |
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| Primary | Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD) ) | Change from baseline in glycated haemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data [OC-AD]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects. | Modified intention-to-treat set (mITT) (observed case - all data [OC-AD]): Patients in the TS who had a baseline and at least 1 post-baseline HbA1c measurement. | Posted | Least Squares Mean | Standard Error | Percentage (%) | Baseline to week 26 |
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| Secondary | Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycaemia Adverse Events (AEs) With Confirmed Plasma Glucose (PG) | This is a key secondary endpoint. Rate per patient-year of investigator-reported symptomatic hypoglycaemia adverse events (AEs) with confirmed plasma glucose (PG) <54 milligram per deciliter (mg/dL) (<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycaemia AEs (i.e. all investigator-reported AEs that had confirmed PG <54 mg/dL [<3.0 mmol/L] with symptoms reported and all severe hypoglycaemia events that were confirmed by adjudication) is presented for (i) From week 5 to 26 and (ii) From week 1 to 26. Least squares mean is actually an adjusted event rate. | FAS (OC) | Posted | Least Squares Mean | 95% Confidence Interval | Event per patient year | Week 5 to Week 26, Week 1 to Week 26 |
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| Secondary | Change From Baseline in Body Weight at Week 26 | Change from baseline in body weight is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. | FAS (OC) | Posted | Least Squares Mean | Standard Error | Kilogram (kg) | Baseline to week 26 |
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| Secondary | Change From Baseline in Percentage of Time Spent in Target Glucose Range From Weeks 23 to 26 | Change from baseline in the percentage of time spent in target glucose range of >70 to ≤180 mg/dL (>3.9 to ≤10.0 mmol/L) as determined by continuous glucose monitoring (CGM) is presented in week 23 to 26. Least squares mean is actually an adjusted event rate. | FAS observed cases excluding data after use of paracetamol (OC-P) | Posted | Least Squares Mean | Standard Error | Percentage of time | Week 23 to 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Interstitial Glucose Variability Based on the Interquartile Range (IQR) as Determined by CGM in Weeks 23 to 26 | Change from baseline in interstitial glucose variability based on the IQR as determined by CGM is presented for week 23 to 26. Least squares mean is actually an adjusted event rate. | FAS observed cases excluding data after use of paracetamol (OC-P) | Posted | Least Squares Mean | Standard Error | milligrams (mg)/ deciliter (dL) | Week 23 to 26 |
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| Secondary | Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26 | Change from baseline in TDID is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. | FAS (OC) | Posted | Least Squares Mean | Standard Error | Unit/kilogram (U/kg) | Baseline to week 26 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26 | Change from baseline in SBP and DBP is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. | FAS observed cases excluding data after change in use of anti-hypertensives (OC-H) | Posted | Least Squares Mean | Standard Error | Millimeters of mercury (mmHg) | Baseline to week 26 |
|
From the first dose of trial medication until 7 days after last in-take of trial medication, up to 422 days
Treated set (TS): all patients who were treated with at least one dose of randomised trial medication; the TS was the basis for safety analyses. The total number of participants at risk is based on treated set.
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 | Placebo Matching Empagliflozin | Patients administered placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimised insulin therapy for 52 weeks. | 0 | 243 | 28 | 243 | 197 | 243 |
| EG001 | Empagliflozin 10 mg | Patients administered Empagliflozin 10 mg film-coated tablet orally once daily in addition as adjunctive to optimised insulin therapy for 52 weeks. | 0 | 243 | 43 | 243 | 197 | 243 |
| EG002 | Empagliflozin 25 mg | Patients administered Empagliflozin 25 mg film-coated tablet orally once daily in addition as adjunctive to optimised insulin therapy for 52 weeks. | 0 | 244 | 26 | 244 | 195 | 244 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Macular fibrosis | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Normal tension glaucoma | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pleurisy viral | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Carbon monoxide poisoning | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Shunt malfunction | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood ketone body increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Clostridium test positive | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ketosis | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lacunar stroke | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Radicular syndrome | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Psychiatric decompensation | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acquired phimosis | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Menstrual disorder | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood ketone body increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2017 | Oct 21, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Superiority |
| Model MMRM included the fixed categorical effects of treatment, pre-existing insulin therapy, visit, and treatment-by- visit interaction, as well as the continuous, fixed covariates of baseline HbA1c, baseline eGFR, and baseline HbA1c-by- visit interaction. Patient was included as random effect. An unstructured covariance structure was used to model the within-patient measurements. | MMRM | <0.0001 | Mean Difference (Final Values) | -0.53 | Standard Error of the Mean | 0.06 | 2-Sided | 97.5 | -0.66 | -0.41 | Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean | Superiority |
| Empagliflozin 25 mg |
Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks. |
|
|
|
Patients administered empagliflozin 25 mg film-coated tablet orally once daily as adjunctive to optimised insulin therapy for 52 weeks.
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