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SURPASS-3: A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03882970
Collaborator
(none)
1,444
Enrollment
122
Locations
4
Arms
21.2
Actual Duration (Months)
11.8
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1444 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Phase 3, Open-Label Trial Comparing the Effect of LY3298176 Versus Titrated Insulin Degludec on Glycemic Control in Patients With Type 2 Diabetes
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Dec 11, 2020
Actual Study Completion Date :
Jan 4, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 5 mg Tirzepatide

5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    		•
    Experimental: 10 mg Tirzepatide

    10 mg tirzepatide administered SC once a week.

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176

    		•
    Experimental: 15 mg Tirzepatide

    15 mg tirzepatide administered SC once a week.

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176

    		•
    Active Comparator: Insulin Degludec

    Insulin degludec administered SC once a day.

    Drug: Insulin Degludec
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    2. 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.

    3. 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).

    4. 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.

    5. 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).

    6. Percentage of Participants Who Achieved Weight Loss ≥5% [Week 52]

      Percentage of Participants who Achieved Weight Loss ≥5%

    7. 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).

    8. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arkansas Clinical Research Little Rock Arkansas United States 72205
    2 Valley Research Fresno California United States 93720
    3 National Research Institute Huntington Park California United States 90255
    4 National Research Institute Los Angeles California United States 90057
    5 Catalina Research Institute, LLC Montclair California United States 91763
    6 Valley Clinical Trials, Inc. Northridge California United States 91325
    7 National Research Institute Panorama City California United States 91402
    8 Encompass Clinical Research Spring Valley California United States 91978
    9 University Clinical Investigators, Inc. Tustin California United States 92780
    10 Chase Medical Research, LLC Waterbury Connecticut United States 06708
    11 Indago Research & Health Center, Inc. Hialeah Florida United States 33012
    12 East Coast Clinical Research Jacksonville Florida United States 32204
    13 East Coast Institute For Research Jacksonville Florida United States 32216
    14 Bayside Clinical Research, LLC New Port Richey Florida United States 34655
    15 East Coast Institute For Research Macon Georgia United States 31210
    16 Sky Clinical Research Network Union City Georgia United States 30291
    17 Elite Clinical Trials LLLP Blackfoot Idaho United States 83221
    18 Humphreys Diabetes Center Boise Idaho United States 83702
    19 Rocky Mountain Diabetes and Osteoporosis Center Idaho Falls Idaho United States 83404
    20 Springfield Diabetes & Endocrine Center Springfield Illinois United States 62711
    21 Crescent City Clinical Research Metairie Louisiana United States 70006
    22 Endocrine and Metabolic Consultants Rockville Maryland United States 20852
    23 Troy Internal Medicine, PC Troy Michigan United States 48098
    24 International Diabetes Center Minneapolis Minnesota United States 55416
    25 Clinical Research Professionals Chesterfield Missouri United States 63005
    26 Palm Research Center Las Vegas Nevada United States 89128
    27 Palm Research Center Las Vegas Nevada United States 89148
    28 Aventiv Research Columbus Ohio United States 43213
    29 The Corvallis Clinic P.C. Corvallis Oregon United States 97330
    30 Heritage Valley Medical Group, Inc. Beaver Pennsylvania United States 15009
    31 Detweiler Family Medicine Lansdale Pennsylvania United States 19446
    32 Office of Dr. Osvaldo Brusco Corpus Christi Texas United States 78414
    33 Consano Clinical Research Shavano Park Texas United States 78231
    34 Mautalen Salud e Investigación - Servicio de Endocrinología Caba Buenos Aires Argentina C1128AAF
    35 Investigaciones Medicas IMOBA S.R.L. Caba Buenos Aires Argentina C1179AAB
    36 CEDIC-Centro de Investigaciones Clinicas Caba Buenos Aires Argentina C1425DES
    37 Centro de Investigacion y Prevencion Cardiovascular (CIPREC) Ciudad Autonoma de Buenos Aires Argentina C1119ACN
    38 CIPADI Godoy Cruz Mendoza Argentina M5501ARP
    39 AXISMED SRL - Bioclinica Research Network Buenos Aires Argentina C1430CKE
    40 Centro Médico Viamonte Ciudad Autonoma de Buenos Aire Argentina C1120AAC
    41 Instituto Centenario Ciudad Autonoma de Buenos Aire Argentina C1204AAD
    42 CENUDIAB Ciudad Autonoma de Buenos Aire Argentina C1440AAD
    43 Landesklinikum Korneuburg-Stockerau, Standort Stockerau Stockerau Niederösterreich Austria 2000
    44 Universitätsklinikum Graz Graz Steiermark Austria 8036
    45 Universitätsklinikum Salzburg Salzburg Austria 5020
    46 KA Rudolfstiftung Wien Austria 1030
    47 Iatriko Palaiou Falirou, Medical Center Palaio Faliro Athens Greece 17562
    48 Laiko General Hospital of Athens Ampelokipoi Attica Greece 11527
    49 Gen Hospital of Athens G Gennimatas Athens Attiki Greece 11527
    50 General Hospital of Thessaloniki Papageorgiou N. Efkarpia Thessaloniki Greece 56403
    51 Thermi Clinic Thermi Thessaloniki Greece 57001
    52 Athens Euroclinic Athens Greece 11521
    53 University General Hospital of Larissa Larissa Greece 41110
    54 AHEPA Hospital Thessaloniki Greece 54636
    55 Ippokrateio General Hospital of Thessaloniki Thessaloniki Greece 54639
    56 Euromedica - General Clinic of Thessaloniki Thessaloniki Greece 54645
    57 Kenezy Gyula Korhaz es Rendelointezet Debrecen Hajdu-Bihar Hungary 4031
    58 Szent Margit Rendelointezet Budapest Hungary 1032
    59 ClinDiab Kft. Budapest Hungary 1089
    60 XIII.ker Onkormanyzat Egeszsegugyi Szolgalat Budapest Hungary 1139
    61 Strazsahegy Medicina Bt. Budapest Hungary 1171
    62 TRANTOR 99 Bt. Budapest Hungary 1213
    63 Kanizsai Dorottya Korhaz Nagykanizsa Hungary 8800
    64 Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary 8900
    65 Azienda ospedaliero-universitaria Mater Domini Germaneto Catanzaro Italy 88100
    66 Policlinico Univ. Agostino Gemelli Roma Lazio Italy 00168
    67 Centro Cardiologico Monzino, IRCCS Milano MI Italy 20138
    68 Azienda Ospedaliera Policlinico Consorziale Bari Italy 70124
    69 Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy 24128
    70 Ospedale Santa Maria Goretti Latina Italy 04100
    71 Bucheon St. Mary's Hospital Bucheon, Gyeonggi-do Korea, Republic of 14647
    72 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 13620
    73 Hanyang University Guri Hospital Guri-si Gyeonggido Korea, Republic of 11923
    74 Seoul St. Mary's Hospital Seoul Korea Korea, Republic of 06591
    75 Korea University Ansan Hospital Ansan-si Korea, Republic of 15355
    76 Korea University Anam Hospital Seoul Korea, Republic of 02841
    77 Seoul National University Hospital Seoul Korea, Republic of 03080
    78 Severance Hospital Yonsei University Health System Seoul Korea, Republic of 03722
    79 Kyunghee University Hospital at Gangdong Seoul Korea, Republic of 05278
    80 Samsung Medical Center Seoul Korea, Republic of 06351
    81 Ambulatorium Barbara Bazela Elblag Warminsko-Mazurki Poland 82300
    82 NZOZ ZDROWIE Osteo-Medic Bialystok Poland 15-351
    83 Poradnia Diabetologiczna SN ZOZ Lege Artis Bialystok Poland 15-404
    84 NZOZ Diab-Endo-Met Krakow Poland 31-261
    85 Gabinet Lekarski Malgorzata Saryusz-Wolska Lodz Poland 90-132
    86 Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Lodz Poland 90-242
    87 NZOZ Przychodnia Specjalistyczna MEDICA Lublin Poland 20-538
    88 NZOZ Przychodnia Specjalistyczna Henryk RudzkiAndrzej Wittek Ruda Slaska Poland 41-709
    89 Latin Clinical Trial Center San Juan Puerto Rico 00909
    90 GCM Medical Group PSC San Juan Puerto Rico 00917
    91 San Miguel Medical Trujillo Alto Puerto Rico 00976
    92 S. C. Grandmed S.R.L., Str. Oradea Bihor Romania 410159
    93 Spitalul Judetean de Urgenta Satu Mare Satu-Mare Jud Satu-Mare Romania 440055
    94 SC Diamed Obesity SRL Galati Judetul Galati Romania 800291
    95 CMI DNBM Dr. Pop Lavinia Baia Mare Maramures Romania 430222
    96 Cosamext SRL Targu Mures Mures Romania 540098
    97 Societatea Civila Medicala "Dr. Paveliu" Bucuresti Sect.5 Romania 050538
    98 Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL Brasov Romania 500283
    99 Cabinetul Medical Nicodiab SRL Bucharest Romania 010507
    100 SC Nutrilife SRL Bucuresti Romania 013671
    101 Consultmed SRL Iasi Romania 700547
    102 Hospital Infanta Luisa Sevilla Andalucía Spain 41010
    103 Hospital Universitario Marques De Valdecilla Santander Cantabria Spain 39011
    104 Hospital Universitario Quiron Madrid Pozuelo de Alarcon Madrid Spain 28223
    105 Instituto de Ciencias médicas Alicante Spain 03004
    106 Hospital Clinico Universitario San Cecilio Granada Spain 18016
    107 Clinica Juaneda Palma de Mallorca Spain 07014
    108 Clinica Nuevas Tecnologias en Diabetes y Endocrinologia Seville Spain 41003
    109 Policlinica Galileo Teruel Spain 44002
    110 Changhua Christian Hospital Changhua Taiwan 500
    111 Chang Gung Memorial Hospital - Kaohsiung Kaohsiung City Taiwan 833
    112 Taipei Medical University- Shuang Ho Hospital New Taipei Taiwan 23561
    113 Chung Shan Medical University Hospital Taichung City Taiwan 40201
    114 Kuang Tien General Hospital Taichung County Taiwan 433
    115 Taichung Veterans General Hospital Taichung Taiwan 40705, ROC
    116 Chi-Mei Medical Center Tainan City Taiwan 71004
    117 National Cheng Kung University Hospital Tainan Taiwan 70403
    118 Taipei Veterans General Hospital Taipei Taiwan 11217
    119 Dnipro City Clinical Hospital #9 Dnipro Ukraine 49023
    120 V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine Kyiv Ukraine 04114
    121 Communal Institution "Poltava Reg.Cl.H. n.a.M.V.Sklifosovskogo" Poltava Ukraine 36011
    122 Vinnytsia Regional Clinical Highly Specialized Endocrinology Center Vinnytsia Ukraine 21000

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03882970
    Other Study ID Numbers:
    • 16997
    • I8F-MC-GPGH
    • 2018-003422-84
    First Posted:
    Mar 20, 2019
    Last Update Posted:
    Jan 19, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eli Lilly and Company
    T2DM
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Tirzepatide

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Insulin Degludec
    Arm/Group Description 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week SC. Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values.
    Period Title: Overall Study
    STARTED 359 361 359 365
    Received at Least One Dose of Study Drug 358 360 359 360
    COMPLETED 333 321 340 331
    NOT COMPLETED 26 40 19 34

    Baseline Characteristics

    Arm/Group Title 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Insulin Degludec Total
    Arm/Group Description 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week SC. Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values. Total of all reporting groups
    Overall Participants 359 361 359 365 1444
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    57.20
    (10.13)
    57.40
    (9.66)
    57.50
    (10.24)
    57.50
    (10.08)
    57.40
    (10.02)
    Sex: Female, Male (Count of Participants)
    Female
    158
    44%
    165
    45.7%
    165
    46%
    148
    40.5%
    636
    44%
    Male
    201
    56%
    196
    54.3%
    194
    54%
    217
    59.5%
    808
    56%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    109
    30.4%
    108
    29.9%
    96
    26.7%
    108
    29.6%
    421
    29.2%
    Not Hispanic or Latino
    247
    68.8%
    253
    70.1%
    259
    72.1%
    256
    70.1%
    1015
    70.3%
    Unknown or Not Reported
    3
    0.8%
    0
    0%
    4
    1.1%
    1
    0.3%
    8
    0.6%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    1
    0.3%
    1
    0.3%
    2
    0.5%
    4
    0.3%
    Asian
    20
    5.6%
    19
    5.3%
    20
    5.6%
    19
    5.2%
    78
    5.4%
    Native Hawaiian or Other Pacific Islander
    1
    0.3%
    0
    0%
    2
    0.6%
    1
    0.3%
    4
    0.3%
    Black or African American
    13
    3.6%
    12
    3.3%
    8
    2.2%
    11
    3%
    44
    3%
    White
    324
    90.3%
    329
    91.1%
    327
    91.1%
    332
    91%
    1312
    90.9%
    More than one race
    1
    0.3%
    0
    0%
    1
    0.3%
    0
    0%
    2
    0.1%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    Argentina
    57
    15.9%
    54
    15%
    56
    15.6%
    57
    15.6%
    224
    15.5%
    Austria
    7
    1.9%
    8
    2.2%
    4
    1.1%
    8
    2.2%
    27
    1.9%
    Greece
    33
    9.2%
    35
    9.7%
    35
    9.7%
    34
    9.3%
    137
    9.5%
    Hungary
    36
    10%
    37
    10.2%
    37
    10.3%
    37
    10.1%
    147
    10.2%
    Italy
    6
    1.7%
    8
    2.2%
    8
    2.2%
    8
    2.2%
    30
    2.1%
    Poland
    33
    9.2%
    33
    9.1%
    33
    9.2%
    33
    9%
    132
    9.1%
    Puerto Rico
    8
    2.2%
    7
    1.9%
    11
    3.1%
    9
    2.5%
    35
    2.4%
    Romania
    54
    15%
    54
    15%
    53
    14.8%
    53
    14.5%
    214
    14.8%
    South Korea
    9
    2.5%
    10
    2.8%
    8
    2.2%
    9
    2.5%
    36
    2.5%
    Spain
    21
    5.8%
    21
    5.8%
    22
    6.1%
    22
    6%
    86
    6%
    Taiwan
    9
    2.5%
    8
    2.2%
    10
    2.8%
    9
    2.5%
    36
    2.5%
    Ukraine
    11
    3.1%
    11
    3%
    12
    3.3%
    11
    3%
    45
    3.1%
    United States
    75
    20.9%
    75
    20.8%
    70
    19.5%
    75
    20.5%
    295
    20.4%
    Hemoglobin A1c (Percentage of HbA1c) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Percentage of HbA1c]
    8.17
    (0.89)
    8.18
    (0.89)
    8.21
    (0.94)
    8.12
    (0.94)
    8.17
    (0.91)

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)
    Description 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).
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)
    Arm/Group Title 10 mg Tirzepatide 15 mg Tirzepatide Insulin Degludec
    Arm/Group Description 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week SC. Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values.
    Measure Participants 291 294 317
    Least Squares Mean (Standard Error) [Percentage of HbA1c]
    -2.20
    (0.051)
    -2.37
    (0.050)
    -1.34
    (0.049)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 10 mg Tirzepatide, Insulin Degludec
    Comments
    Type of Statistical Test Non-Inferiority
    Comments The study was powered for superiority in HbA1c. The sample size provided >99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.86
    Confidence Interval (2-Sided) 95%
    -1.00 to -0.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 15 mg Tirzepatide, Insulin Degludec
    Comments
    Type of Statistical Test Non-Inferiority
    Comments The study was powered for superiority in HbA1c. The sample size provided >99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.04
    Confidence Interval (2-Sided) 95%
    -1.17 to -0.90
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Change From Baseline in HbA1c (5 mg)
    Description 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).
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)
    Arm/Group Title 5 mg Tirzepatide Insulin Degludec
    Arm/Group Description 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values.
    Measure Participants 312 317
    Least Squares Mean (Standard Error) [Percentage of HbA1c]
    -1.93
    (0.050)
    -1.34
    (0.049)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 10 mg Tirzepatide, 15 mg Tirzepatide
    Comments
    Type of Statistical Test Non-Inferiority
    Comments The study was powered for superiority in HbA1c. The sample size provided >99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.59
    Confidence Interval (2-Sided) 95%
    -0.73 to -0.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Change From Baseline in Body Weight
    Description 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.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)
    Arm/Group Title 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Insulin Degludec
    Arm/Group Description 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week SC. Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values.
    Measure Participants 310 291 295 317
    Least Squares Mean (Standard Error) [Kilograms (kg)]
    -7.5
    (0.37)
    -10.7
    (0.37)
    -12.9
    (0.37)
    2.3
    (0.37)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 10 mg Tirzepatide, Insulin Degludec
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -9.8
    Confidence Interval (2-Sided) 95%
    -10.8 to -8.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 15 mg Tirzepatide, Insulin Degludec
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -13.0
    Confidence Interval (2-Sided) 95%
    -14.0 to -11.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Insulin Degludec, Insulin Degludec
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -15.2
    Confidence Interval (2-Sided) 95%
    -16.2 to -14.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Change From Baseline in Fasting Serum Glucose
    Description 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).
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)
    Arm/Group Title 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Insulin Degludec
    Arm/Group Description 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week SC. Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values.
    Measure Participants 309 291 293 314
    Least Squares Mean (Standard Error) [milligram per Deciliter (mg/dL)]
    -48.2
    (1.82)
    -54.8
    (1.86)
    -59.2
    (1.85)
    -55.7
    (1.81)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 10 mg Tirzepatide, Insulin Degludec
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.004
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 7.5
    Confidence Interval (2-Sided) 95%
    2.4 to 12.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 15 mg Tirzepatide, Insulin Degludec
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.751
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.8
    Confidence Interval (2-Sided) 95%
    -4.3 to 5.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Insulin Degludec, Insulin Degludec
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.168
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -3.6
    Confidence Interval (2-Sided) 95%
    -8.7 to 1.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Percentage of Participants Achieving an HbA1c Target Value of <7%
    Description 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.
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)
    Arm/Group Title 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Insulin Degludec
    Arm/Group Description 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week SC. Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values.
    Measure Participants 353 350 353 351
    Number [percentage of participants]
    82.44
    23%
    89.71
    24.9%
    92.63
    25.8%
    61.25
    16.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 10 mg Tirzepatide, Insulin Degludec
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.45
    Confidence Interval (2-Sided) 95%
    2.38 to 5.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 15 mg Tirzepatide, Insulin Degludec
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 7.02
    Confidence Interval (2-Sided) 95%
    4.55 to 10.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Insulin Degludec, Insulin Degludec
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 10.79
    Confidence Interval (2-Sided) 95%
    6.65 to 17.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
    Description 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).
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)
    Arm/Group Title 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Insulin Degludec
    Arm/Group Description 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week SC. Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values.
    Measure Participants 281 263 274 288
    Least Squares Mean (Standard Error) [mg/dL]
    -52.6
    (1.20)
    -59.7
    (1.22)
    -60.6
    (1.20)
    -48.0
    (1.18)
    7. Secondary Outcome
    Title Percentage of Participants Who Achieved Weight Loss ≥5%
    Description Percentage of Participants who Achieved Weight Loss ≥5%
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)
    Arm/Group Title 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Insulin Degludec
    Arm/Group Description 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week SC. Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values.
    Measure Participants 353 350 353 351
    Number [percentage of participants]
    66.01
    18.4%
    83.71
    23.2%
    87.82
    24.5%
    6.27
    1.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 10 mg Tirzepatide, Insulin Degludec
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 29.78
    Confidence Interval (2-Sided) 95%
    18.35 to 48.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 15 mg Tirzepatide, Insulin Degludec
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 79.88
    Confidence Interval (2-Sided) 95%
    47.56 to 134.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Insulin Degludec, Insulin Degludec
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 110.77
    Confidence Interval (2-Sided) 95%
    64.73 to 189.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score
    Description 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).
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)
    Arm/Group Title 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Insulin Degludec
    Arm/Group Description 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week SC. Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values.
    Measure Participants 306 293 292 313
    Hyperglycemia
    -1.4
    (0.11)
    -1.4
    (0.11)
    -1.6
    (0.11)
    -1.1
    (0.11)
    Hypoglycemia
    -1.1
    (0.12)
    -0.9
    (0.12)
    -1.0
    (0.12)
    -0.7
    (0.12)
    Treatment Satisfaction Score
    15.6
    (0.27)
    15.5
    (0.28)
    15.6
    (0.28)
    12.6
    (0.27)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 10 mg Tirzepatide, Insulin Degludec
    Comments Hyperglycemia
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.096
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.26
    Confidence Interval (2-Sided) 95%
    -0.57 to 0.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 15 mg Tirzepatide, Insulin Degludec
    Comments Hyperglycemia
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.113
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.25
    Confidence Interval (2-Sided) 95%
    -0.57 to 0.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Insulin Degludec, Insulin Degludec
    Comments Hyperglycemia
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.47
    Confidence Interval (2-Sided) 95%
    -0.78 to -0.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 10 mg Tirzepatide, Insulin Degludec
    Comments Hypoglycemia
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.014
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.41
    Confidence Interval (2-Sided) 95%
    -0.74 to -0.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection 15 mg Tirzepatide, Insulin Degludec
    Comments Hypoglycemia
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.280
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.18
    Confidence Interval (2-Sided) 95%
    -0.51 to 0.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Insulin Degludec, Insulin Degludec
    Comments Hypoglycemia
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.129
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.26
    Confidence Interval (2-Sided) 95%
    -0.59 to 0.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection 10 mg Tirzepatide, Insulin Degludec
    Comments Treatment Satisfaction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 3.01
    Confidence Interval (2-Sided) 95%
    2.26 to 3.75
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection 15 mg Tirzepatide, Insulin Degludec
    Comments Treatment Satisfaction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.90
    Confidence Interval (2-Sided) 95%
    2.15 to 3.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Insulin Degludec, Insulin Degludec
    Comments Treatment Satisfaction Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.99
    Confidence Interval (2-Sided) 95%
    2.24 to 3.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia
    Description 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.
    Time Frame Baseline through Safety Follow-Up (Up to Week 56)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or stopping study drug (last dose date +7 days)
    Arm/Group Title 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Insulin Degludec
    Arm/Group Description 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. 10 mg tirzepatide administered SC once a week. 15 mg tirzepatide administered SC once a week SC. Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values.
    Measure Participants 356 360 359 358
    Mean (Standard Error) [Episodes/participant/365.25 days]
    0.0137
    (0.0056)
    0.0108
    (0.0044)
    0.0275
    (0.0143)
    0.1020
    (0.0568)

    Adverse Events

    Time Frame Baseline Up To 56 Weeks
    Adverse Event Reporting Description All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    Arm/Group Title 5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Insulin Degludec
    Arm/Group Description 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. 15 mg tirzepatide administered SC once a week SC. Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values.
    All Cause Mortality
    5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Insulin Degludec
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/358 (0.3%) 2/360 (0.6%) 1/359 (0.3%) 1/360 (0.3%)
    Serious Adverse Events
    5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Insulin Degludec
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 29/358 (8.1%) 20/360 (5.6%) 26/359 (7.2%) 22/360 (6.1%)
    Blood and lymphatic system disorders
    Neutropenia 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Thrombocytopenia 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Cardiac disorders
    Acute myocardial infarction 2/358 (0.6%) 2 0/360 (0%) 0 0/359 (0%) 0 2/360 (0.6%) 2
    Atrial fibrillation 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Atrial tachycardia 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Cardiac arrest 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Cardiac failure 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 1/360 (0.3%) 1
    Cardiac failure congestive 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Cardio-respiratory arrest 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 0/360 (0%) 0
    Coronary artery disease 1/358 (0.3%) 1 1/360 (0.3%) 1 0/359 (0%) 0 1/360 (0.3%) 1
    Myocardial infarction 1/358 (0.3%) 1 1/360 (0.3%) 1 1/359 (0.3%) 1 0/360 (0%) 0
    Ventricular tachycardia 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 2 0/360 (0%) 0
    Congenital, familial and genetic disorders
    Arrhythmogenic right ventricular dysplasia 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Ear and labyrinth disorders
    Vertigo 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Endocrine disorders
    Inappropriate antidiuretic hormone secretion 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Eye disorders
    Cataract 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Retinal detachment 0/358 (0%) 0 1/360 (0.3%) 2 0/359 (0%) 0 0/360 (0%) 0
    Gastrointestinal disorders
    Constipation 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 0/360 (0%) 0
    Diarrhoea 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 0/360 (0%) 0
    Diverticulum intestinal haemorrhagic 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Dyspepsia 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Gastric ulcer haemorrhage 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 0/360 (0%) 0
    Gastritis alcoholic 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Gastrointestinal haemorrhage 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 0/360 (0%) 0
    Inguinal hernia 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Lower gastrointestinal haemorrhage 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Pancreatitis acute 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 0/360 (0%) 0
    Segmental diverticular colitis 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 0/360 (0%) 0
    General disorders
    Multiple organ dysfunction syndrome 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Necrosis 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Non-cardiac chest pain 2/358 (0.6%) 2 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Hepatobiliary disorders
    Cholecystitis 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Cholelithiasis 1/358 (0.3%) 1 1/360 (0.3%) 1 1/359 (0.3%) 1 0/360 (0%) 0
    Malignant biliary obstruction 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 0/360 (0%) 0
    Infections and infestations
    Cellulitis 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Cellulitis orbital 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Colon gangrene 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Coronavirus infection 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Covid-19 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Covid-19 pneumonia 1/358 (0.3%) 1 1/360 (0.3%) 1 1/359 (0.3%) 1 0/360 (0%) 0
    Device related infection 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Diverticulitis 1/358 (0.3%) 1 0/360 (0%) 0 1/359 (0.3%) 1 1/360 (0.3%) 1
    Endocarditis 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Gastroenteritis 1/358 (0.3%) 1 1/360 (0.3%) 1 1/359 (0.3%) 1 0/360 (0%) 0
    Hepatitis e 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Intervertebral discitis 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Osteomyelitis 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 1/360 (0.3%) 1
    Pneumonia 0/358 (0%) 0 0/360 (0%) 0 2/359 (0.6%) 2 2/360 (0.6%) 2
    Pyelonephritis acute 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Sepsis 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Septic shock 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Systemic candida 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Injury, poisoning and procedural complications
    Accident 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Ankle fracture 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 0/360 (0%) 0
    Craniocerebral injury 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Femur fracture 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Foot fracture 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Head injury 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Hip fracture 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Injury 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Limb traumatic amputation 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Lumbar vertebral fracture 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Maternal exposure during pregnancy 0/158 (0%) 0 1/165 (0.6%) 1 0/165 (0%) 0 0/147 (0%) 0
    Tendon injury 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Investigations
    Sars-cov-2 test positive 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 0/360 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Lumbar spinal stenosis 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Rotator cuff syndrome 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon 0/358 (0%) 0 1/360 (0.3%) 1 1/359 (0.3%) 1 0/360 (0%) 0
    Cholangiocarcinoma 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 0/360 (0%) 0
    Gastric neoplasm 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Invasive breast carcinoma 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 0/360 (0%) 0
    Invasive ductal breast carcinoma 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Lung adenocarcinoma stage iv 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 0/360 (0%) 0
    Metastases to liver 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Neoplasm skin 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Neuroendocrine carcinoma 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 2 0/360 (0%) 0
    Pituitary tumour benign 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Squamous cell carcinoma 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Testicular neoplasm 1/200 (0.5%) 1 0/195 (0%) 0 0/194 (0%) 0 0/213 (0%) 0
    Transitional cell carcinoma 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Nervous system disorders
    Diabetic neuropathy 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Haemorrhagic stroke 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Hypoglycaemic unconsciousness 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Subarachnoid haemorrhage 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Syncope 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Transient ischaemic attack 2/358 (0.6%) 2 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Vertebrobasilar insufficiency 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 0/158 (0%) 0 1/165 (0.6%) 1 0/165 (0%) 0 0/147 (0%) 0
    Psychiatric disorders
    Alcohol abuse 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Depression suicidal 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Major depression 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Suicide attempt 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 2
    Renal and urinary disorders
    Acute kidney injury 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Haematuria 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Nephrolithiasis 1/358 (0.3%) 1 1/360 (0.3%) 1 1/359 (0.3%) 1 0/360 (0%) 0
    Renal colic 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 0/360 (0%) 0
    Reproductive system and breast disorders
    Cervical dysplasia 0/158 (0%) 0 0/165 (0%) 0 1/165 (0.6%) 1 0/147 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Asthma 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Pneumothorax 0/358 (0%) 0 1/360 (0.3%) 1 0/359 (0%) 0 0/360 (0%) 0
    Pulmonary embolism 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Respiratory failure 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Skin and subcutaneous tissue disorders
    Diabetic foot 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Skin ulcer 0/358 (0%) 0 0/360 (0%) 0 0/359 (0%) 0 1/360 (0.3%) 1
    Vascular disorders
    Deep vein thrombosis 1/358 (0.3%) 1 0/360 (0%) 0 0/359 (0%) 0 0/360 (0%) 0
    Dry gangrene 0/358 (0%) 0 0/360 (0%) 0 1/359 (0.3%) 1 0/360 (0%) 0
    Other (Not Including Serious) Adverse Events
    5 mg Tirzepatide 10 mg Tirzepatide 15 mg Tirzepatide Insulin Degludec
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 124/358 (34.6%) 157/360 (43.6%) 179/359 (49.9%) 66/360 (18.3%)
    Gastrointestinal disorders
    Abdominal pain 7/358 (2%) 7 17/360 (4.7%) 28 23/359 (6.4%) 46 4/360 (1.1%) 5
    Diarrhoea 55/358 (15.4%) 92 59/360 (16.4%) 97 56/359 (15.6%) 107 14/360 (3.9%) 18
    Dyspepsia 14/358 (3.9%) 14 32/360 (8.9%) 39 18/359 (5%) 28 0/360 (0%) 0
    Nausea 41/358 (11.5%) 86 81/360 (22.5%) 140 85/359 (23.7%) 240 6/360 (1.7%) 6
    Vomiting 21/358 (5.9%) 29 34/360 (9.4%) 53 36/359 (10%) 63 4/360 (1.1%) 4
    Infections and infestations
    Nasopharyngitis 11/358 (3.1%) 11 14/360 (3.9%) 15 15/359 (4.2%) 16 22/360 (6.1%) 27
    Investigations
    Lipase increased 21/358 (5.9%) 25 16/360 (4.4%) 18 20/359 (5.6%) 21 7/360 (1.9%) 7
    Metabolism and nutrition disorders
    Decreased appetite 22/358 (6.1%) 23 37/360 (10.3%) 59 43/359 (12%) 54 2/360 (0.6%) 2
    Vascular disorders
    Hypertension 11/358 (3.1%) 11 7/360 (1.9%) 8 11/359 (3.1%) 11 21/360 (5.8%) 22

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email ClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03882970
    Other Study ID Numbers:
    • 16997
    • I8F-MC-GPGH
    • 2018-003422-84
    First Posted:
    Mar 20, 2019
    Last Update Posted:
    Jan 19, 2022
    Last Verified:
    Jan 1, 2022