Type 2 Diabetes Mellitus
Conditions
Keywords
GIP, GLP-1, glucose metabolism disorders, metabolic diseases, endocrine system diseases, cardiovascular risk
Brief summary
The purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. The study will last about 108 weeks and may include up to 30 visits.
Interventions
DRUGTirzepatide
Administered SC.
DRUGInsulin Glargine
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must: * Have been diagnosed with type 2 diabetes mellitus (T2DM) * Have HbA1c between ≥7.5% and ≤10.5% * Be on stable treatment with unchanged dose of at least 1 and no more than 3 types of oral antihyperglycemic drugs, which may only include metformin, SGLT-2 inhibitors, and/or sulfonylureas for at least 3 months before screening * Have increased risk for cardiovascular (CV) events * Be of stable weight (± 5%) * 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 immediate or urgent 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 there ALT level is ≤3.0 the ULN for the reference range * 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, SGLT-2 inhibitors, and/or sulfonylureas during the last 3 months * Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 for post-baseline measures: Variable = Baseline + Pooled Country + Baseline sodium-glucose co-transporter-2 inhibitor (SGLT-2i) use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Weight | Baseline, Week 52 | LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares). |
| Percentage of Participants With HbA1c of <7.0% | 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. Imputed data includes observed value and imputed value if endpoint measure is missing. |
| Change From Baseline in Fasting Serum Glucose | Baseline, Week 52 | LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares). |
| 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. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares). |
| Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide | 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post dose of Week 7, 15, 23, 35 | Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide |
| Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia | Baseline through Week 52 | 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. Post-baseline comparisons between treatment and control group was evaluated using negative binomial model with variables : Number of episodes = Baseline HbA1c Group (\<=8.5%, \>8.5%) + Pooled Country + Baseline SGLT-2i use Flag (Yes, No) + 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 + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares). |
Countries
Argentina, Australia, Brazil, Canada, Greece, Israel, Mexico, Poland, Puerto Rico, Romania, Russia, Slovakia, Spain, Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 5 mg Tirzepatide 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. | 329 |
| 10 mg Tirzepatide 10 mg tirzepatide administered SC once a week. | 330 |
| 15 mg Tirzepatide 15 mg tirzepatide administered SC once a week. | 338 |
| Insulin Glargine Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.
The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm. | 1,005 |
| Total | 2,002 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Treatment Period (52 Weeks) | Adverse Event | 3 | 2 | 0 | 3 |
| Treatment Period (52 Weeks) | Death | 6 | 2 | 2 | 9 |
| Treatment Period (52 Weeks) | Lost to Follow-up | 4 | 2 | 2 | 11 |
| Treatment Period (52 Weeks) | Personal Reason | 2 | 2 | 0 | 2 |
| Treatment Period (52 Weeks) | Physician Decision | 1 | 1 | 0 | 3 |
| Treatment Period (52 Weeks) | Protocol Violation | 0 | 1 | 0 | 1 |
| Treatment Period (52 Weeks) | Screen Failure | 0 | 1 | 0 | 0 |
| Treatment Period (52 Weeks) | Withdrawal by Subject | 5 | 0 | 5 | 23 |
| Variable Treatment Period | Adverse Event | 1 | 2 | 0 | 7 |
| Variable Treatment Period | Death | 9 | 0 | 6 | 26 |
| Variable Treatment Period | Lost to Follow-up | 2 | 1 | 4 | 11 |
| Variable Treatment Period | Personal Reason | 0 | 2 | 1 | 6 |
| Variable Treatment Period | Physician Decision | 0 | 0 | 0 | 3 |
| Variable Treatment Period | Protocol Violation | 0 | 1 | 1 | 1 |
| Variable Treatment Period | Withdrawal by Subject | 2 | 1 | 4 | 17 |
Baseline characteristics
| Characteristic | Total | Insulin Glargine | 15 mg Tirzepatide | 10 mg Tirzepatide | 5 mg Tirzepatide |
|---|---|---|---|---|---|
| Age, Continuous | 63.60 years STANDARD_DEVIATION 8.56 | 63.80 years STANDARD_DEVIATION 8.51 | 63.70 years STANDARD_DEVIATION 8.6 | 63.70 years STANDARD_DEVIATION 8.68 | 62.90 years STANDARD_DEVIATION 8.56 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 951 Participants | 478 Participants | 155 Participants | 164 Participants | 154 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1036 Participants | 521 Participants | 179 Participants | 164 Participants | 172 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 6 Participants | 4 Participants | 2 Participants | 3 Participants |
| Hemoglobin A1c | 8.52 Percentage of HbA1c STANDARD_DEVIATION 0.88 | 8.50 Percentage of HbA1c STANDARD_DEVIATION 0.85 | 8.52 Percentage of HbA1c STANDARD_DEVIATION 0.98 | 8.59 Percentage of HbA1c STANDARD_DEVIATION 0.91 | 8.52 Percentage of HbA1c STANDARD_DEVIATION 0.84 |
| Race (NIH/OMB) American Indian or Alaska Native | 174 Participants | 86 Participants | 26 Participants | 30 Participants | 32 Participants |
| Race (NIH/OMB) Asian | 70 Participants | 31 Participants | 8 Participants | 16 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 76 Participants | 34 Participants | 11 Participants | 18 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 43 Participants | 24 Participants | 5 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 1632 Participants | 827 Participants | 285 Participants | 260 Participants | 260 Participants |
| Region of Enrollment Argentina | 484 Participants | 242 Participants | 82 Participants | 80 Participants | 80 Participants |
| Region of Enrollment Australia | 19 Participants | 9 Participants | 4 Participants | 3 Participants | 3 Participants |
| Region of Enrollment Brazil | 250 Participants | 125 Participants | 42 Participants | 41 Participants | 42 Participants |
| Region of Enrollment Canada | 51 Participants | 27 Participants | 7 Participants | 9 Participants | 8 Participants |
| Region of Enrollment Greece | 38 Participants | 19 Participants | 7 Participants | 5 Participants | 7 Participants |
| Region of Enrollment Israel | 29 Participants | 15 Participants | 5 Participants | 5 Participants | 4 Participants |
| Region of Enrollment Mexico | 160 Participants | 80 Participants | 26 Participants | 27 Participants | 27 Participants |
| Region of Enrollment Poland | 156 Participants | 78 Participants | 26 Participants | 25 Participants | 27 Participants |
| Region of Enrollment Romania | 82 Participants | 41 Participants | 14 Participants | 14 Participants | 13 Participants |
| Region of Enrollment Russia | 88 Participants | 45 Participants | 15 Participants | 14 Participants | 14 Participants |
| Region of Enrollment Slovakia | 199 Participants | 100 Participants | 34 Participants | 32 Participants | 33 Participants |
| Region of Enrollment Spain | 77 Participants | 38 Participants | 14 Participants | 14 Participants | 11 Participants |
| Region of Enrollment Taiwan | 30 Participants | 15 Participants | 5 Participants | 5 Participants | 5 Participants |
| Region of Enrollment United States | 339 Participants | 171 Participants | 57 Participants | 56 Participants | 55 Participants |
| Sex: Female, Male Female | 751 Participants | 364 Participants | 135 Participants | 121 Participants | 131 Participants |
| Sex: Female, Male Male | 1251 Participants | 641 Participants | 203 Participants | 209 Participants | 198 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 15 / 329 | 2 / 328 | 8 / 338 | 35 / 1,000 |
| other Total, other adverse events | 112 / 329 | 158 / 328 | 184 / 338 | 192 / 1,000 |
| serious Total, serious adverse events | 48 / 329 | 54 / 328 | 41 / 338 | 193 / 1,000 |
Outcome results
Primary
Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)
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 for post-baseline measures: Variable = Baseline + Pooled Country + Baseline sodium-glucose co-transporter-2 inhibitor (SGLT-2i) use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Time frame: Baseline, Week 52
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) | -2.43 Percentage of HbA1c | Standard Error 0.053 |
| 15 mg Tirzepatide | Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) | -2.58 Percentage of HbA1c | Standard Error 0.053 |
| Insulin Glargine | Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) | -1.44 Percentage of HbA1c | Standard Error 0.03 |
p-value: <0.00197.5% CI: [-1.13, -0.86]Mixed Models Analysis
p-value: <0.00197.5% CI: [-1.28, -1]Mixed Models Analysis
Secondary
Change From Baseline in Body Weight
LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Time frame: Baseline, Week 52
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Change From Baseline in Body Weight | -7.1 Kilograms (kg) | Standard Error 0.34 |
| 15 mg Tirzepatide | Change From Baseline in Body Weight | -9.5 Kilograms (kg) | Standard Error 0.34 |
| Insulin Glargine | Change From Baseline in Body Weight | -11.7 Kilograms (kg) | Standard Error 0.33 |
| Insulin Glargine | Change From Baseline in Body Weight | 1.9 Kilograms (kg) | Standard Error 0.19 |
p-value: <0.00195% CI: [-9.8, -8.3]Mixed Models Analysis
p-value: <0.00195% CI: [-12.1, -10.6]Mixed Models Analysis
p-value: <0.00195% CI: [-14.3, -12.8]Mixed Models Analysis
Secondary
Change From Baseline in Fasting Serum Glucose
LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Time frame: Baseline, Week 52
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Change From Baseline in Fasting Serum Glucose | -50.4 milligram per Deciliter (mg/dL) | Standard Error 2.07 |
| 15 mg Tirzepatide | Change From Baseline in Fasting Serum Glucose | -54.9 milligram per Deciliter (mg/dL) | Standard Error 2.06 |
| Insulin Glargine | Change From Baseline in Fasting Serum Glucose | -59.3 milligram per Deciliter (mg/dL) | Standard Error 2.04 |
| Insulin Glargine | Change From Baseline in Fasting Serum Glucose | -51.4 milligram per Deciliter (mg/dL) | Standard Error 1.17 |
p-value: 0.67295% CI: [-3.7, 5.7]Mixed Models Analysis
p-value: 0.13495% CI: [-8.2, 1.1]Mixed Models Analysis
p-value: <0.00195% CI: [-12.6, -3.4]Mixed Models Analysis
Secondary
Change From Baseline in HbA1c (5 mg)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Time frame: Baseline, Week 52
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Change From Baseline in HbA1c (5 mg) | -2.24 Percentage of HbA1c | Standard Error 0.053 |
| 15 mg Tirzepatide | Change From Baseline in HbA1c (5 mg) | -1.44 Percentage of HbA1c | Standard Error 0.03 |
p-value: <0.00197.5% CI: [-0.93, -0.66]Mixed Models Analysis
Secondary
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values
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 + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Time frame: Baseline, Week 52
Population: All randomized participants who received at least one dose of study drug, excluding participants discontinuing study drug due to inadvertent enrollment
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values | -58.4 mg/dL | Standard Error 1.65 |
| 15 mg Tirzepatide | Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values | -61.1 mg/dL | Standard Error 1.66 |
| Insulin Glargine | Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values | -66.1 mg/dL | Standard Error 1.66 |
| Insulin Glargine | Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values | -46.1 mg/dL | Standard Error 0.96 |
Secondary
Percentage of Participants With HbA1c of <7.0%
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing.
Time frame: Week 52
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10 mg Tirzepatide | Percentage of Participants With HbA1c of <7.0% | 80.98 percentage of participants |
| 15 mg Tirzepatide | Percentage of Participants With HbA1c of <7.0% | 88.16 percentage of participants |
| Insulin Glargine | Percentage of Participants With HbA1c of <7.0% | 90.72 percentage of participants |
| Insulin Glargine | Percentage of Participants With HbA1c of <7.0% | 50.72 percentage of participants |
p-value: <0.00195% CI: [3.47, 6.58]Regression, Logistic
p-value: <0.00195% CI: [6.31, 13.49]Regression, Logistic
p-value: <0.00195% CI: [7.88, 17.89]Regression, Logistic
Secondary
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide
Time frame: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post dose of Week 7, 15, 23, 35
Population: Pharmacokinetic samples were collected from atleast the first 150 participants at each Tirzepatide dose, all participants aged ≥70 years, and all participants with severe renal impairment or end-stage renal disease (ESRD) (estimated glomerular filtration rate \[eGFR\] \<30 mL/min)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide | 81800 Nanograms per millilitre per hour | Geometric Coefficient of Variation 23.9 |
| 15 mg Tirzepatide | Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide | 165000 Nanograms per millilitre per hour | Geometric Coefficient of Variation 20.3 |
| Insulin Glargine | Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide | 246000 Nanograms per millilitre per hour | Geometric Coefficient of Variation 20.6 |
Secondary
Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia
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. Post-baseline comparisons between treatment and control group was evaluated using negative binomial model with variables : Number of episodes = Baseline HbA1c Group (\<=8.5%, \>8.5%) + Pooled Country + Baseline SGLT-2i use Flag (Yes, No) + Treatment, with log (exposure in days/365.25) as an offset variable
Time frame: Baseline through Week 52
Population: All randomized participants who received at least one dose of study drug, excluding participants hypoglycemic events occurring after initiation of a new antihyperglycemic therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Tirzepatide | Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia | 0.10 Episodes/participant/365.25 days | Standard Error 0.023 |
| 15 mg Tirzepatide | Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia | 0.09 Episodes/participant/365.25 days | Standard Error 0.025 |
| Insulin Glargine | Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia | 0.11 Episodes/participant/365.25 days | Standard Error 0.03 |
| Insulin Glargine | Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia | 0.35 Episodes/participant/365.25 days | Standard Error 0.044 |