A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03882970
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes. The study will last about 67 weeks and may include up to 22 visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1444
-
Participants must:
- Have been diagnosed with type 2 diabetes mellitus (T2DM)
- Have HbA1c between ≥7.0% and ≤10.5%
- Be on stable treatment with unchanged dose of metformin or metformin plus an SGLT-2 inhibitor for at least 3 months before screening
- Be of stable weight (± 5%) for at least 3 months before screening
- Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening
-
Participants must not:
- Have type 1 diabetes mellitus
- Have had chronic or acute pancreatitis any time prior to study entry
- Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment
- Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
- Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if their ALT level is ≤3.0 the ULN for the reference range
- Have an estimated glomerular filtration rate <45 mL/minute/1.73 m2 (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
- Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
- Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
- Have been taking any other diabetes medicines other than metformin, or metformin plus an SGLT-2 inhibitor during the last 3 months
- Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10 mg Tirzepatide Tirzepatide 10 mg tirzepatide administered SC once a week. 5 mg Tirzepatide Tirzepatide 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. 15 mg Tirzepatide Tirzepatide 15 mg tirzepatide administered SC once a week. Insulin Degludec Insulin Degludec Insulin degludec administered SC once a day.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) Baseline, Week 52 HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates Baseline + Pooled Country + Baseline Oral Antihyperglycemic Medication (OAM) Use (Metformin (Met), Met plus SGLT-2i) + Treatment + Time + Treatment\*Time (Type III sum of squares).
- Secondary Outcome Measures
Name Time Method Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score Week 52 DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 52 or early termination.The treatment satisfaction score ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline DTSQs + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment (Type III sum of squares).
Change From Baseline in Body Weight Baseline, Week 52 LS mean was determined by MMRM model with Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as covariates.
Percentage of Participants Achieving an HbA1c Target Value of <7% Week 52 Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing. Missing endpoint measures are imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for Baseline Value, Pooled Country, Baseline OAM Use (Met, Met plus SGLT-2i), Treatment, Visit and Visit\*Treatment.
Change From Baseline in HbA1c (5 mg) Baseline, Week 52 HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Change From Baseline in Fasting Serum Glucose Baseline, Week 52 LS mean was determined by MMRM model with variables Baseline + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percentage of Participants Who Achieved Weight Loss ≥5% Week 52 Percentage of Participants who Achieved Weight Loss ≥5%
Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia Baseline through Safety Follow-Up (Up to Week 56) The hypoglycemia events were defined by participant reported events with blood glucose \<54mg/dL (\<3.0 mmol/L) or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: Number of episodes = Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment, with log (exposure in days/365.25) as an offset variable.
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values Baseline, Week 52 The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. LS mean was determined by mixed-model repeated measures (MMRM) model with variables Baseline + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Pooled Country + Baseline OAM Use (Met, Met plus SGLT-2i) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Trial Locations
- Locations (118)
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
National Research Institute
🇺🇸Panorama City, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Bayside Clinical Research, LLC
🇺🇸New Port Richey, Florida, United States
Sky Clinical Research Network
🇺🇸Union City, Georgia, United States
Elite Clinical Trials LLLP
🇺🇸Blackfoot, Idaho, United States
Springfield Diabetes & Endocrine Center
🇺🇸Springfield, Illinois, United States
Crescent City Clinical Research
🇺🇸Metairie, Louisiana, United States
Troy Internal Medicine, PC
🇺🇸Troy, Michigan, United States
Endocrine and Metabolic Consultants
🇺🇸Rockville, Maryland, United States
The Corvallis Clinic P.C.
🇺🇸Corvallis, Oregon, United States
Heritage Valley Medical Group, Inc.
🇺🇸Beaver, Pennsylvania, United States
Detweiler Family Medicine
🇺🇸Lansdale, Pennsylvania, United States
Consano Clinical Research
🇺🇸Shavano Park, Texas, United States
CEDIC-Centro de Investigaciones Clinicas
🇦🇷Caba, Buenos Aires, Argentina
Mautalen Salud e Investigación - Servicio de Endocrinología
🇦🇷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
CIPADI
🇦🇷Godoy Cruz, Mendoza, Argentina
AXISMED SRL - Bioclinica Research Network
🇦🇷Buenos Aires, Argentina
Centro Médico Viamonte
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
Instituto Centenario
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
CENUDIAB
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
Universitätsklinikum Graz
🇦🇹Graz, Steiermark, Austria
Landesklinikum Korneuburg-Stockerau, Standort Stockerau
🇦🇹Stockerau, Niederösterreich, Austria
Universitätsklinikum Salzburg
🇦🇹Salzburg, Austria
KA Rudolfstiftung
🇦🇹Wien, Austria
Iatriko Palaiou Falirou, Medical Center
🇬🇷Palaio Faliro, Athens, Greece
Laiko General Hospital of Athens
🇬🇷Ampelokipoi, Attica, Greece
Gen Hospital of Athens G Gennimatas
🇬🇷Athens, Attiki, Greece
General Hospital of Thessaloniki Papageorgiou
🇬🇷N. Efkarpia, Thessaloniki, Greece
Thermi Clinic
🇬🇷Thermi, Thessaloniki, Greece
Athens Euroclinic
🇬🇷Athens, Greece
University General Hospital of Larissa
🇬🇷Larissa, Greece
Ippokrateio General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Euromedica - General Clinic of Thessaloniki
🇬🇷Thessaloniki, Greece
Szent Margit Rendelointezet
🇭🇺Budapest, Hungary
ClinDiab Kft.
🇭🇺Budapest, Hungary
TRANTOR 99 Bt.
🇭🇺Budapest, Hungary
Kanizsai Dorottya Korhaz
🇭🇺Nagykanizsa, Hungary
Zala Megyei Szent Rafael Korhaz
🇭🇺Zalaegerszeg, Hungary
Policlinico Univ. Agostino Gemelli
🇮🇹Roma, Lazio, Italy
Azienda ospedaliero-universitaria Mater Domini
🇮🇹Germaneto, Catanzaro, Italy
Centro Cardiologico Monzino, IRCCS
🇮🇹Milano, MI, Italy
Azienda Ospedaliera Policlinico Consorziale
🇮🇹Bari, Italy
Bucheon St. Mary's Hospital
🇰🇷Bucheon,, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Ospedale Santa Maria Goretti
🇮🇹Latina, Italy
Hanyang University Guri Hospital
🇰🇷Guri-si, Gyeonggido, Korea, Republic of
Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan-si, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Kyunghee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Ambulatorium Barbara Bazela
🇵🇱Elblag, Warminsko-Mazurki, Poland
NZOZ ZDROWIE Osteo-Medic
🇵🇱Bialystok, Poland
NZOZ Diab-Endo-Met
🇵🇱Krakow, Poland
Poradnia Diabetologiczna SN ZOZ Lege Artis
🇵🇱Bialystok, Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
🇵🇱Lodz, Poland
NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek
🇵🇱Ruda Slaska, Poland
NZOZ Przychodnia Specjalistyczna MEDICA
🇵🇱Lublin, Poland
San Miguel Medical
🇵🇷Trujillo Alto, Puerto Rico
Spitalul Judetean de Urgenta Satu Mare
🇷🇴Satu-Mare, Jud Satu-Mare, Romania
S. C. Grandmed S.R.L., Str.
🇷🇴Oradea, Bihor, Romania
SC Diamed Obesity SRL
🇷🇴Galati, Judetul Galati, Romania
CMI DNBM Dr. Pop Lavinia
🇷🇴Baia Mare, Maramures, Romania
Cosamext SRL
🇷🇴Targu Mures, Mures, Romania
Societatea Civila Medicala "Dr. Paveliu"
🇷🇴Bucuresti, Sect.5, Romania
Cabinetul Medical Nicodiab SRL
🇷🇴Bucharest, Romania
Hospital Infanta Luisa
🇪🇸Sevilla, Andalucía, Spain
Hospital Universitario Marques De Valdecilla
🇪🇸Santander, Cantabria, Spain
Consultmed SRL
🇷🇴Iasi, Romania
Instituto de Ciencias médicas
🇪🇸Alicante, Spain
Policlinica Galileo
🇪🇸Teruel, Spain
Clinica Nuevas Tecnologias en Diabetes y Endocrinologia
🇪🇸Seville, Spain
Hospital Clinico Universitario San Cecilio
🇪🇸Granada, Spain
Clinica Juaneda
🇪🇸Palma de Mallorca, Spain
Chang Gung Memorial Hospital - Kaohsiung
🇨🇳Kaohsiung City, Taiwan
Kuang Tien General Hospital
🇨🇳Taichung County, Taiwan
Changhua Christian Hospital
🇨🇳Changhua, Taiwan
Taipei Medical University- Shuang Ho Hospital
🇨🇳New Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Dnipro City Clinical Hospital #9
🇺🇦Dnipro, Ukraine
V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine
🇺🇦Kyiv, Ukraine
Communal Institution "Poltava Reg.Cl.H. n.a.M.V.Sklifosovskogo"
🇺🇦Poltava, Ukraine
Vinnytsia Regional Clinical Highly Specialized Endocrinology Center
🇺🇦Vinnytsia, Ukraine
Valley Research
🇺🇸Fresno, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Indago Research & Health Center, Inc.
🇺🇸Hialeah, Florida, United States
East Coast Institute For Research
🇺🇸Macon, Georgia, United States
Humphreys Diabetes Center
🇺🇸Boise, Idaho, United States
Rocky Mountain Diabetes and Osteoporosis Center
🇺🇸Idaho Falls, Idaho, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
Palm Research Center
🇺🇸Las Vegas, Nevada, United States
Aventiv Research
🇺🇸Columbus, Ohio, United States
Office of Dr. Osvaldo Brusco
🇺🇸Corpus Christi, Texas, United States
Hospital Universitario Quiron Madrid
🇪🇸Pozuelo de Alarcon, Madrid, Spain
International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
AHEPA Hospital
🇬🇷Thessaloniki, Greece
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
Chung Shan Medical University Hospital
🇨🇳Taichung City, Taiwan
Strazsahegy Medicina Bt.
🇭🇺Budapest, Hungary
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kenezy Gyula Korhaz es Rendelointezet
🇭🇺Debrecen, Hajdu-Bihar, Hungary
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Gabinet Lekarski Malgorzata Saryusz-Wolska
🇵🇱Lodz, Poland
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Chi-Mei Medical Center
🇨🇳Tainan City, Taiwan
XIII.ker Onkormanyzat Egeszsegugyi Szolgalat
🇭🇺Budapest, Hungary
Azienda Ospedaliera Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
🇷🇴Brasov, Romania
SC Nutrilife SRL
🇷🇴Bucuresti, Romania
Arkansas Clinical Research
🇺🇸Little Rock, Arkansas, United States
GCM Medical Group PSC
🇵🇷San Juan, Puerto Rico
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
East Coast Clinical Research
🇺🇸Jacksonville, Florida, United States