Diabetes Mellitus, Type 2 Clinical Trial
— AWARD-11Official title:
A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide Doses When Added to Metformin in Patients With Type 2 Diabetes Mellitus
| Verified date | December 15, 2019 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with type 2 diabetes with inadequate blood sugar control.
| Status | Completed |
| Enrollment | 1842 |
| Est. completion date | October 10, 2019 |
| Est. primary completion date | May 28, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Have type 2 diabetes mellitus (T2DM) for at least 6 months - Have been treated with stable metformin dose for at least 3 months - Have HbA1c =7.5% and =11.0% at study entry - Have body mass index (BMI) =25 kilograms per meter squared (kg/m^2) Exclusion Criteria: - Have type 1 diabetes mellitus - Have used any glucagon-like peptide-1 receptor agonist (GLP-1 RA) or insulin, not including prior short term insulin use (=14 days) - Have been taking any other medicine for diabetes (other than metformin) during the last 3 months - Have used in the last 3 months (or plan to use) prescription weight loss medications - Have disorders associated with slowed emptying of the stomach contents, or have had any stomach surgeries for the purpose of weight loss - Current participation in or intent to begin during the study an organized diet and/or exercise weight reduction program (other than the lifestyle and dietary measures for diabetes) - Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial - Had chronic or acute pancreatitis any time prior to study entry - Have had a heart attack or stroke in the past 2 months, or have heart failure that significantly limits their physical activity - Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73m^2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead-in - Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2 - Have proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | AXISMED SRL - Bioclinica Research Network | Buenos Aires | |
| Argentina | CEDIC-Centro de Investigaciones Clinicas | Caba | Buenos Aires |
| Argentina | Centro Medico CICEMO | Caba | Buenos Aires |
| Argentina | Investigaciones Medicas IMOBA S.R.L. | Caba | Buenos Aires |
| Argentina | Centro de Investigacion y Prevencion Cardiovascular (CIPREC) | Ciudad Autonoma de | Buenos Aires |
| Argentina | Mautalen Salud e Investigación - Servicio de Endocrinología | Ciudad Autonoma De Buenos Air | |
| Argentina | Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff | Ciudad Autonoma de Buenos Aire | |
| Argentina | Centro de Investigaciones Metabólicas (CINME) | Ciudad Autonoma de Buenos Aire | Buenos Aires |
| Argentina | Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada | Ciudad Autonoma de Buenos Aire | Buenos Aires |
| Argentina | Centro Médico Viamonte | Ciudad Autonoma de Buenos Aire | |
| Argentina | CENUDIAB | Ciudad Autonoma de Buenos Aire | |
| Argentina | Instituto Centenario | Ciudad Autonoma de Buenos Aire | |
| Argentina | Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC | Cordoba | |
| Argentina | Centro Medico Privado San Vicente Diabetes | Cordoba | |
| Argentina | Instituto Medico Strusberg | Cordoba | |
| Argentina | CIPADI | Godoy Cruz | Mendoza |
| Argentina | Instituto de Investigaciones Clinicas Mar del Plata | Mar del Plata | Buenos Aires |
| Austria | VIVIT Institut am LKH Feldkirch | Feldkirch | Vorarlberg |
| Austria | Universitätsklinikum Graz | Graz | Steiermark |
| Austria | Ordination Dr. Evelyn Fließer-Görzer | Saint Stefan Ob Stainz | Steiermark |
| Austria | Landesklinikum Korneuburg-Stockerau, Standort Stockerau | Stockerau | Niederösterreich |
| Austria | KA Rudolfstiftung | Wien | |
| Austria | Zentrum für klinische Studien Dr. Ursula Hanusch GmbH | Wien | |
| Canada | Aggarwal and Associates Ltd | Brampton | Ontario |
| Canada | T. Nemtean Medicine Professional Corporation | Mississauga | Ontario |
| Canada | Bailey Clinic | Red Deer | Alberta |
| Canada | Bluewater Clinical Research Group Inc | Sarnia | Ontario |
| Canada | Stayner Medical Clinic | Stayner | Ontario |
| Canada | Dr. Anil K. Gupta Medicine Professional Corporation | Toronto | Ontario |
| Greece | Laiko General Hospital of Athens | Ampelokipoi | Attica |
| Greece | Athens Euroclinic | Athens | |
| Greece | Gen Hospital of Athens G Gennimatas | Athens | Attiki |
| Greece | G.Papanikolaou General Hospital | Exohi | Thessaloniki |
| Greece | University General Hospital of Larissa | Larissa | |
| Greece | Iatriko Palaiou Falirou, Medical Center | Palaio Faliro | Athens |
| Greece | Thermi Clinic | Thermi | Thessaloniki |
| Greece | AHEPA Hospital | Thessaloniki | |
| Greece | Euromedica - General Clinic of Thessaloniki | Thessaloniki | |
| Greece | Ippokrateio General Hospital of Thessaloniki | Thessaloniki | |
| Hungary | ClinDiab Kft. | Budapest | |
| Hungary | Strazsahegy Medicina Bt. | Budapest | |
| Hungary | Szent Margit Rendelointezet | Budapest | |
| Hungary | TRANTOR 99 Bt. | Budapest | |
| Hungary | Kenezy Gyula Korhaz es Rendelointezet | Debrecen | Hajdu-Bihar |
| Hungary | Studium Egeszseghaz Kft. | Kalocsa | Bacs-Kiskun |
| Hungary | Kanizsai Dorottya Korhaz | Nagykanizsa | |
| Hungary | Grof Esterhazy Korhaz es Rendelointezeti Szakrendelo | Papa | Veszprem |
| Hungary | Zala Megyei Szent Rafael Korhaz | Zalaegerszeg | |
| Israel | Linn Medical Center | Haifa | |
| Israel | Maccabi Diabetes Clinic, Grand Canyon, North District, Haifa | Haifa | |
| Israel | Hadassah Medical Center | Jerusalem | |
| Israel | Meir Medical Center | Kfar Saba | |
| Israel | Clalit Health Services - Shuali Clinic | Raanana | |
| Israel | ZIV Medical Center | Safed | |
| Israel | Sakhnin Community Clinic, Clalit Health Services | Sakhnin | |
| Israel | Diabetes Medical Center (DMC) | Tel Aviv | |
| Israel | Tel Aviv Sourasky Medical Center | Tel Aviv Jaffa | |
| Italy | Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | |
| Italy | Policlinico Mater Domini | Catanzaro | |
| Italy | Fondazione Universitaria degli Studi G D'Annunzio | Chieti | |
| Italy | Azienda Ospedaliera Universitaria Careggi | Firenze | Florence |
| Italy | Ospedale Santa Maria Goretti | Latina | |
| Italy | Policlinico Giaccone | Palermo | |
| Italy | Istituto Clinico Humanitas | Rozzano | Milano |
| Italy | A.O.U. Senese Policlinico Santa Maria alle Scotte | Siena | SI |
| Italy | Ospedale Civile Maggiore Borgo Trento | Verona | |
| Mexico | Investigacion en Salud y Metabolismo S.C | Chihuahua | |
| Mexico | Hospital Univ. Dr. Jose Eleuterio Gonzalez | Monterrey | Nuevo León |
| Poland | NS ZOZ Osrodek Diabetologiczny " Popula" | Bialystok | |
| Poland | NZOZ ZDROWIE Osteo-Medic | Bialystok | |
| Poland | Poradnia Diabetologiczna SN ZOZ Lege Artis | Bialystok | |
| Poland | Centrum Badan Klinicznych, PI House | Gdansk | |
| Poland | NZOZ Salvia s.c. | Katowice | |
| Poland | NZOZ Diab-Endo-Met | Krakow | |
| Poland | Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. | Lodz | |
| Poland | Gabinety Terpa | Lublin | |
| Poland | NZOZ Przychodnia Specjalistyczna MEDICA | Lublin | |
| Poland | Centrum Medyczne OMEDICA | Poznan | |
| Poland | Nzoz Neuro - Kard | Poznan | |
| Poland | Praktyka Lekarska | Poznan | |
| Poland | NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek | Ruda Slaska | |
| Poland | Centralny Szpital Kliniczny MSW | Warszawa | |
| Poland | Regionalna Poradnia Diabetologiczna | Wroclaw | |
| Puerto Rico | Research and Cardiovascular Corp. | Ponce | |
| Puerto Rico | Clinical Research Puerto Rico, Inc. | San Juan | |
| Puerto Rico | GCM Medical Group PSC | San Juan | |
| Puerto Rico | Office: Dr. Luis Rivera Colon | San Juan | |
| Romania | CMI DNBM Dr. Pop Lavinia | Baia Mare | Maramures |
| Romania | Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL | Brasov | |
| Romania | Cabinetul Medical Nicodiab SRL | Bucharest | |
| Romania | Easydiet SRL | Bucuresti | |
| Romania | SC Nutrilife SRL | Bucuresti | |
| Romania | SC Medcon SRL | Buzau | |
| Romania | Centrul Medical Unirea SRL | Cluj Napoca | |
| Romania | Cabinet Medical Urodiamed S.R.L. | Craiova | |
| Romania | Milena Sante SRL | Galati | |
| Romania | SC Olimpia Med SRL | Iasi | |
| Romania | SC Gama Diamed SRL | Mangalia | Constanta |
| Romania | S. C. Grandmed S.R.L., Str. | Oradea | Bihor |
| Romania | SC Diabmed Dr Popescu Alexandrina SRL | Ploiesti | Prahova |
| Romania | SC Dianutrilife Medica SRL | Ploiesti | Prahova |
| Romania | Spitalul Judetean de Urgenta Satu Mare | Satu-Mare | Jud Satu-Mare |
| Romania | Cosamext SRL | Targu Mures | Mures |
| Romania | Centrul Medical Dr. Negrisanu | Timisoara | Timis |
| Russian Federation | Arkhangelsk Regional Clinical Hospital | Arkhangelsk | |
| Russian Federation | Arkhangelsk the first city clinical hospital | Arkhangelsk | |
| Russian Federation | Rostov State Medical University | Rostov-on-Don | |
| Russian Federation | City Hospital of Saint Martyr Elizabeth | Saint Petersburg | |
| Russian Federation | SPb GUZ "Diagnostic Center #85" | Saint Petersburg | |
| Russian Federation | Regional Clinical Hospital | Saratov | |
| Slovakia | Diacrin s.r.o. | Bratislava | |
| Slovakia | Human care s.r.o. | Kosice | Slovak Republic |
| Slovakia | MediVet s.r.o. | Malacky | Slovak Republic |
| Slovakia | Noemis, s.r.o. | Nove Mesto nad Vahom | |
| Slovakia | FUNKYSTUFF s.r.o. | Nove Zamky | |
| Slovakia | MUDr. Jan Culak, s.r.o. | Prievidza | |
| Slovakia | DIA-MED CENTRUM s.r.o. | Puchov | |
| Slovakia | Tatratrial s.r.o. | Roznava | |
| Slovakia | Areteus s.r.o. | Trebisov | Slovak Republic |
| Spain | Instituto de Ciencias medicas | Alicante | |
| Spain | Clinica San Pedro | Almeria | |
| Spain | Centre Medico Teknon | Barcelona | |
| Spain | Hospital Clinico Universitario San Cecilio | Granada | |
| Spain | Virgen de Las Nieves | Granada | |
| Spain | Centro Especialidades San Jose Obrero (Barbarela) | Malaga | |
| Spain | Clinica Juaneda | Palma de Mallorca | Islas Baleares |
| Spain | Hospital Universitario Quiron Madrid | Pozuelo de Alarcon | Madrid |
| Spain | Corporació Sanitaria Parc Tauli | Sabadell | Barcelona |
| Spain | Hospital Universitario Marques De Valdecilla | Santander | Cantabria |
| Spain | Hospital Infanta Luisa | Sevilla | Andalucía |
| Spain | Hospital Universitario Virgen Macarena | Sevilla | |
| Spain | Clinica Nuevas Tecnologias en Diabetes y Endocrinologia | Seville | |
| Spain | Policlinica Galileo | Teruel | |
| Taiwan | Taichung Veterans General Hospital | Taichung | |
| Taiwan | Chung Shan Medical University Hospital | Taichung City | |
| Taiwan | Chi-Mei Medical Center | Tainan City | |
| United States | Anaheim Clinical Trials, LLC | Anaheim | California |
| United States | Heritage Valley Medical Group, Inc. | Beaver | Pennsylvania |
| United States | Montana Health Research | Billings | Montana |
| United States | Elite Clinical Trials LLLP | Blackfoot | Idaho |
| United States | Progressive Clinical Research | Bountiful | Utah |
| United States | Synexus- Chandler | Chandler | Arizona |
| United States | Metrolina Internal Medicine, P.A. | Charlotte | North Carolina |
| United States | Chattanooga Research and Medicine (CHARM) | Chattanooga | Tennessee |
| United States | Clinical Research Professionals | Chesterfield | Missouri |
| United States | Aventiv Research | Columbus | Ohio |
| United States | ALL Medical Research, LLC | Cooper City | Florida |
| United States | Clinical Research of South Florida | Coral Gables | Florida |
| United States | The Corvallis Clinic P.C. | Corvallis | Oregon |
| United States | Dallas Diabetes Endocrine Center | Dallas | Texas |
| United States | Synexus/Clinical Research Advantage | Evansville | Indiana |
| United States | NECCR PrimaCare Research, LLC | Fall River | Massachusetts |
| United States | Aa Mrc Llc | Flint | Michigan |
| United States | Valley Research | Fresno | California |
| United States | Prevea Clinic, Inc | Green Bay | Wisconsin |
| United States | East West Medical Institute | Honolulu | Hawaii |
| United States | Pacific Diabetes & Endocrine Center | Honolulu | Hawaii |
| United States | National Research Institute | Huntington Park | California |
| United States | MedStar Health Research Institute | Hyattsville | Maryland |
| United States | Midwest Institute for Clinical Research | Indianapolis | Indiana |
| United States | Glacier View Research Institute | Kalispell | Montana |
| United States | Detweiler Family Medicine | Lansdale | Pennsylvania |
| United States | Arkansas Clinical Research | Little Rock | Arkansas |
| United States | National Research Institute | Los Angeles | California |
| United States | Manassas Clinical Research Center | Manassas | Virginia |
| United States | Urban Family Practice Associates, PC | Marietta | Georgia |
| United States | Synexus/Central Arizona Medical Associates, PC | Mesa | Arizona |
| United States | Southern Endocrinology and Associates PA | Mesquite | Texas |
| United States | New Horizon Research Center | Miami | Florida |
| United States | Suncoast Research Group, LLC | Miami | Florida |
| United States | PMG Research of Charleston, LLC | Moncks Corner | South Carolina |
| United States | Catalina Research Institute, LLC | Montclair | California |
| United States | Diabetes & Endocrinology Consultants PC | Morehead City | North Carolina |
| United States | Saltzer Medical Group. P.A. | Nampa | Idaho |
| United States | Manhattan Medical Research | New York | New York |
| United States | Intend Research | Norman | Oklahoma |
| United States | Valley Clinical Trials, Inc. | Northridge | California |
| United States | Pacific Research Partners, LLC | Oakland | California |
| United States | Advanced Research Institute | Ogden | Utah |
| United States | IPS Research Company | Oklahoma City | Oklahoma |
| United States | Capital Clincial Research Center | Olympia | Washington |
| United States | Oviedo Medical Research | Oviedo | Florida |
| United States | National Research Institute | Panorama City | California |
| United States | In-Quest Medical Research, LLC- Peachtree Corners | Peachtree Corners | Georgia |
| United States | Central Phoenix Med Clinic LLC | Phoenix | Arizona |
| United States | Preferred Primary Care Physicians | Pittsburgh | Pennsylvania |
| United States | InterMed, PA | Portland | Maine |
| United States | Summit Research Network Inc | Portland | Oregon |
| United States | Clinical Research Partners, LLC | Richmond | Virginia |
| United States | Sierra Clinical Research | Roseville | California |
| United States | StudyMetrix Research, LLC | Saint Peters | Missouri |
| United States | Artemis Institute for Clinical Research | San Diego | California |
| United States | Care Access Research | Santa Clarita | California |
| United States | Consano Clinical Research | Shavano Park | Texas |
| United States | Encompass Clinical Research | Spring Valley | California |
| United States | Prairie Education and Research Cooperative | Springfield | Illinois |
| United States | Martin Diagnostic Clinic | Tomball | Texas |
| United States | Premier Research | Trenton | New Jersey |
| United States | Troy Internal Medicine, PC | Troy | Michigan |
| United States | University Clinical Investigators, Inc. | Tustin | California |
| United States | Walla Walla Clinic | Walla Walla | Washington |
| United States | Diablo Clinical Research | Walnut Creek | California |
| United States | Sudir Bansal M.D. Inc. | Warwick | Rhode Island |
| United States | Chase Medical Research, LLC | Waterbury | Connecticut |
| United States | ClinPoint Trials, LLC | Waxahachie | Texas |
| United States | Wenatchee Valley Hospital & Clinics | Wenatchee | Washington |
| United States | Iderc, P.L.C. | West Des Moines | Iowa |
| United States | Great Lakes Medical Research | Westfield | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Argentina, Austria, Canada, Greece, Hungary, Israel, Italy, Mexico, Poland, Puerto Rico, Romania, Russian Federation, Slovakia, Spain, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Hemoglobin A1c (HbA1c) From Baseline | HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables:Baseline + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 36 | |
| Secondary | Change in Body Weight From Baseline | Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 36 | |
| Secondary | Percentage of Participants Achieving HbA1c Target <7.0% | Percentage of participants achieving HbA1c target <7.0%. | Week 36 | |
| Secondary | Change in Fasting Serum Glucose (FSG) From Baseline | Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 36 | |
| Secondary | Rate of Documented Symptomatic Hypoglycemic Episodes | Hypoglycemia was defined as blood glucose < 54 mg/dL, excluding post-rescue records. Estimate is based on Group Mean from negative binomial model. The negative binomial model for post-baseline comparisons between treatments and control group: Number of episodes = Pooled Country + HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable. | Week 36 | |
| Secondary | Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss) | Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss). | Week 4, Week 12, Week 36, Week 52 | |
| Secondary | Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State | Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State. | Week 4, Week 12, Week 36, Week 52 |
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