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Mounjaro ® (tirzepatide) injection
2.5 mg/5 mg/7.5 mg/10 mg/12.5 mg/15 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
How did Mounjaro® (tirzepatide) compare with prandial insulin lispro as add-on therapy to basal insulin glargine with or without metformin in adults with type 2 diabetes in SURPASS-6?
In SURPASS-6, mean change from baseline in HbA1C was -2.1% with tirzepatide (pooled doses) and -1.1% with insulin lispro at week 52. Noninferiority and superiority were met with an estimated treatment difference of −0.98% (95% CI, −1.17 to −0.79; p<.001).
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
SURPASS-6 Overview
Mounjaro (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) for once-weekly, subcutaneous administration.1
Mounjaro is not a weight loss drug, and individual results may vary.
SURPASS-6 was a 52-week, phase 3b, open-label, multicenter, parallel-group, randomized study of tirzepatide 5, 10, and 15 mg once weekly compared with prandial insulin lispro 3 times daily in 1428 adults with T2D as add-on to titrated insulin glargine with or without metformin.2
Key Inclusion and Exclusion Criteria in SURPASS-6
Key inclusion and exclusion criteria for the SURPASS-6 study are presented in Key Inclusion Criteria and Exclusion Criteria in SURPASS-6.
Key Inclusion Criteria |
Key Exclusion Criteria |
|
|
Abbreviations: BMI = body mass index; DPP-4i = dipeptidyl peptidase-4 inhibitor; eGFR = estimated glomerular filtration rate; HbA1c = glycated hemoglobin; NPH = neutral protamine Hagedorn; T1D = type 1 diabetes; T2D = type 2 diabetes.
aBasal insulins included insulin NPH, insulin glargine, insulin detemir, or insulin degludec.
bTreated for at least 90 days prior to Visit 1.
Study Design in SURPASS-6
This study randomized 1428 adults with T2D across Argentina, Belgium, Brazil, Czech Republic, Germany, Greece, Hungary, Italy, Mexico, Romania, Russia, Slovakia, Spain, Turkey, and the United States in a 1:1:1:3 ratio to receive either
- tirzepatide 5 mg once weekly
- tirzepatide 10 mg once weekly
- tirzepatide 15 mg once weekly, or
- titrated prandial insulin lispro 3 times daily.2
All study treatments were used in combination with basal insulin glargine with or without metformin.2
SURPASS-6 Study Design presents an overview of the SURPASS-6 study design.
Figure 1 description: SURPASS-6 was a phase 3b, 52 week, open-label, multicenter, parallel-group, study in adults with type 2 diabetes inadequately controlled with a stable basal insulin. This study included a 10-week lead-in period for basal insulin stabilization in which participants switched to standardized insulin glargine therapy (100 IU/mL) and discontinued other glucose-lowering medications, except for metformin. During the insulin stabilization period, investigators used their clinical judgment to adjust the insulin glargine dose to a target fasting blood glucose of 100 to 125 mg/dL. Following this 10-week lead-in period, participants with a glycated hemoglobin ≥7.5% were randomized to treatment. Participants were randomized in a 1:1:1:3 ratio to receive once weekly subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or prandial insulin lispro 3 times daily as add-on to titrated insulin glargine with or without metformin. Tirzepatide-treated participants started at a 2.5 mg dose and followed a dose escalation regimen (escalated in 2.5 mg increments every 4 weeks) until the assigned dose was reached, which took up to 20 weeks. Participants treated with insulin lispro started at a dose of 4 IU before the 3 largest meals of the day. Insulin lispro was titrated following a standardized algorithm which included adjusting the dose twice weekly up to week 24 and at least once weekly after week 24. The algorithm targeted a blood glucose of 100 to 125 mg/dL at prelunch, predinner, and bedtime intervals.
Abbreviations: iGlar = insulin glargine; iLispro = insulin lispro; IU = international unit; QW = once weekly; TID = three times a day; TZP = tirzepatide.
Basal Insulin Glargine Titration Regimen in SURPASS-6
At randomization, participants in all groups decreased their insulin glargine dose by 30% to reduce the risk of hypoglycemia during introduction of the treatment drug. Doses of basal insulin glargine were adjusted each week using a titration algorithm to achieve a target fasting blood glucose (FBG) of 100 to 125 mg/dL.2
For participants receiving tirzepatide, up-titration of insulin glargine was not allowed for 4 weeks after randomization.2
Participants achieving the target FBG for 2 consecutive weeks with a low dose of insulin glargine (<10 units) could temporarily interrupt insulin glargine injection based on the investigator decision. Participants continued to measure required FBG for insulin glargine dose adjustment and were re-evaluated every 2 weeks. If participants were not at the target FBG, then insulin glargine was restarted.2
Primary and Secondary Efficacy Endpoints in SURPASS-6
The primary objective of SURPASS-6 was to demonstrate that tirzepatide (pooled cohort) once weekly is noninferior to 3-times daily insulin lispro for mean change from baseline in HbA1c at 52 weeks.2
Key secondary objectives controlled for type 1 error included testing for superiority of tirzepatide (pooled cohort and individual dose groups) compared with insulin lispro at 52 weeks for
- change in glycated hemoglobin (HbA1c) from baseline, and
- change in body weight from baseline.2
The pooled tirzepatide cohort was also tested for superiority compared with insulin lispro for the proportion of participants with HbA1c target values <7% at 52 weeks.2
Baseline Characteristics of Participants in SURPASS-6
In SURPASS-6, baseline demographics and clinical characteristics were similar across groups. At baseline, participants had an overall mean
- age of 59 years
- diabetes duration of 14 years
- HbA1c of 8.8%
- body weight of 90.5 kg
- fasting serum glucose (FSG) of 157 mg/dL.2
In the overall study population, the median insulin glargine dose was 46 IU/d.2
Baseline demographics and clinical characteristics of randomized patients are presented in SURPASS-6: Baseline Demographics and Clinical Characteristics.
Discontinuations During the SURPASS-6
Treatment discontinuation is summarized in Summary of Treatment Discontinuation in SURPASS-6 . In the tirzepatide groups, the most common reasons for discontinuation from study treatment were adverse events (AEs).2
Parametera |
TZP 5 mg |
TZP 10 mg |
TZP 15 mg |
Pooled TZPb |
Insulin Lispro |
Permanent discontinuation from study treatment |
19 (7.8) |
20 (8.4) |
30 (12.7) |
69 (9.6) |
88 (12.4) |
Abbreviation: TZP = tirzepatide.
aData are n (%); all randomized population.
bData for the 5 mg, 10 mg, and 15 mg groups combined.
Efficacy Results
Two statistical estimands, efficacy or treatment-regimen, were used to evaluate efficacy data from the phase 3 clinical trials of tirzepatide. In the SURPASS studies, the
- efficacy estimand evaluates the treatment effect prior to discontinuation of the study drug without confounding effects of antihyperglycemic rescue therapy, and
- treatment-regimen estimand evaluates the treatment effect irrespective of adherence to the study drug or initiation of rescue antidiabetic drugs.2
Differences in reported data may reflect the application of these estimands. This response presents data reflecting the efficacy estimand. For treatment-regimen estimand results, please refer to the manuscript cited where applicable.2
In SURPASS-6, mean change from baseline in HbA1C was -2.1% with tirzepatide (pooled doses) and -1.1% with insulin lispro at week 52. Noninferiority and superiority were met with an estimated treatment difference of −0.98% (95% CI, −1.17 to −0.79; p<.001).2
Additionally, at week 52, superiority was met for mean change in body weight from baseline for tirzepatide (pooled doses) vs insulin lispro. (SURPASS-6: Primary and Secondary Endpoints at 52 Weeks).2
At week 52, the proportion of participants at an HbA1c threshold of <7.0% was
- 72.1% of tirzepatide-treated participants, and
- 36.7 % of insulin lispro-treated participants (SURPASS-6: Primary and Secondary Endpoints at 52 Weeks).2
In exploratory analysis, at week 52 in SURPASS-6, the geometric mean daily insulin glargine dose for the pooled tirzepatide group was 13 IU while the insulin lispro group had a geometric mean daily dose of insulin lispro 62 IU and insulin glargine 42 IU (SURPASS-6: Primary and Secondary Endpoints at 52 Weeks).2
See SURPASS-6: Primary and Secondary Endpoints at 52 Weeks for additional efficacy results.2
Parametera |
TZP 5 mg |
TZP 10 mg |
TZP 15 mg |
Pooled TZPb |
Insulin Lispro |
HbA1c, % |
|||||
Baseline |
8.87±0.06 |
8.77±0.06 |
8.76±0.06 |
8.80±0.04 |
8.80±0.04 |
Change from baseline |
-2.05±0.08 |
-2.27±0.08 |
-2.46±0.08 |
-2.26±0.05 |
-1.16±0.05 |
Difference vs insulin lisproc |
-0.89 (-1.08, -0.70)** |
-1.11 (-1.30, -0.92)** |
-1.30 (-1.49, -1.11)** |
-1.10 (-1.24, -0.97)** |
-- |
Proportion of participants at HbA1c thresholds, n (%)d |
|||||
<7.0% |
148 (61.0)** |
180 (75.6)** |
188 (79.9)** |
516 (72.1)**e |
260 (36.7) |
≤6.5% |
118 (48.9)** |
147 (61.6)** |
165 (69.7)** |
430 (60.0)** |
157 (22.1) |
<5.7% |
31 (12.6)** |
40 (16.8)** |
73 (30.8)** |
143 (20.0)** |
16 (2.3) |
FSG, mg/dL |
|||||
Baseline |
163.4±3.61 |
155.6±3.65 |
156.4±3.67 |
158.4±2.10 |
156.0±2.13 |
Change from baseline |
-39.6±3.08 |
-45.1±3.11 |
-48.9±3.19 |
-44.5±1.81 |
-10.7±1.86 |
Difference vs insulin lisprof |
-28.9 (-36.0, -21.8)** |
-34.4 (-41.5, -27.3)** |
-38.2 (-45.5, -31.0)** |
-33.8 (-38.9, -28.7)** |
-- |
Body weight, kg |
|||||
Baseline |
91.6±1.16 |
89.3±1.18 |
91.3±1.18 |
90.7±0.68 |
90.3±0.69 |
Change from baseline |
-6.9±0.37 |
-9.9±0.37 |
-12.0±0.38 |
-9.6±0.21 |
+3.8±0.22 |
Difference vs insulin lisproc |
-10.7 (-11.5, -9.9)** |
-13.7 (-14.5, -12.9)** |
-15.9 (-16.7, -15.0)** |
-13.4 (-14.0, -12.8)** |
-- |
Proportion of patients achieving at weight reduction thresholds, n (%)f |
|||||
≥5% |
141 (64)** |
175 (79)** |
172 (83)** |
488 (75)** |
37 (6) |
≥10% |
71 (33)** |
114 (52)** |
127 (61)** |
312 (49)** |
12 (2) |
≥15% |
28 (14)** |
64 (30)** |
85 (41)** |
177 (28)** |
2 (<1) |
Daily insulin glargine/insulin lispro dose, geometric mean, IUg |
|||||
Baseline |
47/-- |
47/-- |
47/-- |
47/-- |
47.5/-- |
Week 52 |
20/-- |
12/-- |
8/-- |
13/-- |
41.7/62.3 |
Abbreviations: HbA1c = glycated hemoglobin; IU = international units; LSM = least squares mean; mITT = modified intent-to-treat; TZP = tirzepatide.
Note: Data presented are from the efficacy estimand, which evaluates treatment effect prior to discontinuation of study drug without confounding effects of antihyperglycemic rescue therapy. Missing values were handled by MMRM using the mITT population (efficacy analysis set).
**p<.001 versus insulin lispro.
aData presented as LSM±SE and LSM (95% CI) unless otherwise indicated.
bData for the 5 mg, 10 mg, and 15 mg groups combined.
cTested for superiority and controlled for type 1 error.
dTested for superiority and not controlled for type 1 error, unless otherwise noted.
ePooled TZP cohort tested for superiority and controlled for type 1 error for HbA1c <7.0%.
fTested for superiority, not controlled for type 1 error.
gData for insulin dose are summarized using observed data from the safety population.
Safety Results
The most frequently reported AEs for tirzepatide were gastrointestinal in nature. Most cases of nausea, vomiting, and diarrhea were mild to moderate in severity, transient, and occurred during the dose escalation period. An overview of AEs and treatment-emergent adverse events (TEAEs) with ≥5% frequency are provided in Overview of Adverse Events Through Safety Follow-up 4 Weeks After Treatment Discontinuation in SURPASS-6 and TEAEs Occurring in ≥5% Patients by Preferred Term in SURPASS-6 , respectively.2
Parametera |
TZP 5 mg |
TZP 10 mg |
TZP 15 mg |
Pooled TZPb |
Insulin Lispro |
Patients with ≥1 TEAE |
170 (70.0) |
168 (70.6) |
177 (75.0) |
515 (71.8) |
394 (55.6) |
Patients with ≥1 SAEc |
15 (6.2) |
14 (5.9) |
15 (6.4) |
44 (6.1) |
77 (10.9) |
Deathsd |
3 (1.2) |
3 (1.3) |
1 (0.4) |
7 (1.0) |
11 (1.6) |
AE leading to study treatment discontinuation |
5 (2.1) |
4 (1.7) |
3 (1.3) |
12 (1.7) |
15 (2.1) |
Abbreviations: AE = adverse event; SAE = serious adverse event; TEAE = treatment-emergent adverse event; TZP = tirzepatide.
Note: Safety population included all randomly assigned patients who were exposed to at least 1 dose of study drug.
aData are n (%) from the safety population (safety analysis set). Patients may be counted in more than 1 category.
bData for the 5 mg, 10 mg, and 15 mg groups combined.
cAn SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability or incapacity, was a congenital anomaly or birth defect, or medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes previously listed.
dDeaths are also included as SAEs and discontinuations due to AE. No deaths were considered related to study treatment by the investigator. All deaths were adjudicated by an external committee of physicians with cardiology expertise.
Parametera |
TZP 5 mg |
TZP 10 mg |
TZP 15 mg |
Pooled TZPb |
Insulin Lispro |
Nausea |
33 (13.6) |
49 (20.6) |
61 (25.8) |
143 (19.9) |
8 (1.1) |
COVID-19 |
29 (11.9) |
19 (8.0) |
22 (9.3) |
70 (9.8) |
77 (10.9) |
Diarrhea |
29 (11.9) |
36 (15.1) |
26 (11.0) |
91 (12.7) |
17 (2.4) |
Decreased appetite |
20 (8.2) |
28 (11.8) |
40 (16.9) |
88 (12.3) |
1 (0.1) |
Dyspepsia |
15 (6.2) |
27 (11.3) |
27 (11.4) |
69 (9.6) |
4 (0.6) |
Vomiting |
11 (4.5) |
21 (8.8) |
30 (12.7) |
62 (8.6) |
4 (0.6) |
Urinary tract infection |
9 (3.7) |
2 (0.8) |
12 (5.1) |
23 (3.2) |
27 (3.8) |
Constipation |
6 (2.5) |
8 (3.4) |
14 (5.9) |
28 (3.9) |
4 (0.6) |
Abbreviations: COVID-19 = coronavirus disease 2019; TEAE = treatment-emergent adverse event; TZP = tirzepatide.
Note: Safety population included all randomly assigned patients who were exposed to at least 1 dose of study drug.
aData are n (%) from the safety population (safety analysis set). Patients may be counted in more than 1 category.
bData for the 5 mg, 10 mg, and 15 mg groups combined.
The incidence of clinically significant hypoglycemia, defined as blood glucose <54 mg/dL or severe hypoglycemia, was reported in 11% of participants in the pooled tirzepatide dose group versus 48% of participants in the insulin lispro group.2
Parametera |
TZP 5 mg |
TZP 10 mg |
TZP 15 mg |
Pooled TZPb |
Insulin Lispro |
BG<54 mg/dL or severe hypoglycemia |
29 (11.9) |
22 (9.2) |
25 (10.6) |
76 (10.6) |
340 (48.0) |
BG≤70 mg/dL or severe hypoglycemia |
86 (35.4) |
89 (37.4) |
88 (37.3) |
263 (36.7) |
519 (73.3) |
Severe hypoglycemiac |
0 |
3 (1.3) |
0 |
3 (0.4) |
30 (4.2) |
Abbreviations: BG = blood glucose; TZP = tirzepatide.
Note: Safety population included all randomly assigned patients who were exposed to at least 1 dose of study drug. Clinically significant hypoglycemia events were defined as BG <54 mg/dL or severe hypoglycemia.
aData are n (%) and include safety follow-up using the safety population (safety analysis set). Data exclude hypoglycemia episodes occurring after initiation of new antihyperglycemic therapy.
bData for the 5 mg, 10 mg, and 15 mg groups combined.
cSevere hypoglycemia was defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Basal Insulin Regression in SURPASS-6
A post hoc analysis evaluated baseline clinical characteristics and demographics as well as efficacy and safety measures in tirzepatide-treated patients who achieved insulin regression in SURPASS-6.4,5
This analysis was performed in the pooled population of participants from all 3 tirzepatide arms (tirzepatide 5 mg, 10 mg, and 15 mg doses). It included participants receiving tirzepatide at week 52 (≥75% compliance) without rescue medication. Participants were considered an
In SURPASS-6, 23% (145/651) of tirzepatide-treated participants were considered insulin regressor at week 52.4,5
The baseline mean insulin glargine dose was 40 IU/day in the insulin regressor group and 50 IU/day in the insulin non-regressor group. At week 52, mean insulin glargine dose was 0.4 IU/day and 32 IU/day, respectively.5
Clinical Characteristics of Insulin Regressor Participants in SURPASS-6
Based on multivariate logistic regression, baseline factors associated with insulin regression were
- higher tirzepatide doses (15 mg and 10 mg)
- female sex
- insulin glargine daily use, and
- fasting serum glucose (FSG).4
Efficacy Measures Associated With Insulin Regressor Subgroups
As presented in Efficacy Measures Associated with Insulin Regressor Subgroups, tirzepatide treatment was associated with reduced HbA1c at week 52 by
- 2.6% in the insulin regressor group, and
- 2.2% in the insulin non-regressor group.5
At week 52, tirzepatide treatment was also associated with reduced body weight in both groups by
- 16.1 kg in the insulin regressor group, and
- 7.7 kg in the insulin non-regressor group.5
Figure 3 description: At week 52, tirzepatide treatment was associated with reduced glycated hemoglobin by 2.6% in the insulin regressor group, and 2.2% in the insulin non-regressor group. It was also associated with reduced body weight by 16.1 kg in the insulin regressor group and 7.7 kg in the insulin non-regressor group.
***p<.001 vs baseline.
amITT participants receiving tirzepatide at week 52 (≥75% compliance) without rescue medication; includes pooled data from tirzepatide 5 mg, 10 mg, and 15 mg doses.
Notes: Data are LSM ± SE from MMRM for postbaseline measures: variable=baseline + pooled country + baseline HbA1c group (≤8.5%, >8.5%; weight only) baseline metformin use (yes, no) + treatment + time + treatment*time (type III sum of squares).
Abbreviations: HbA1c = glycated hemoglobin; LSM = least squares mean; mITT = modified intention-to-treat; MMRM = mixed-effects model for repeated measures; W52 = week 52.
Safety of Tirzepatide Based on Insulin Regressor Subgroups
Postbaseline events of clinically significant hypoglycemia (blood glucose <54 mg/dL or severe) were reported by
- 12 (8.28%) participants in the insulin regressor group, and
- 56 (11.29%) participants in the insulin non-regressor group.5
Enclosed Prescribing Information
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2025.
2Rosenstock J, Frías JP, Rodbard HW, et al. Tirzepatide vs insulin lispro added to basal insulin in type 2 diabetes: the SURPASS-6 randomized clinical trial. JAMA. 2023;330(17):1631-1640. https://doi.org/10.1001/jama.2023.20294
3Data on file, Eli Lilly and Company and/or one of its subsidiaries.
4Wysham C, Rosenstock J, Tofe S, et al. Clinical factors associated with insulin regression when adding tirzepatide in basal insulin-treated type 2 diabetes. Poster presented at: 84th Annual Scientific Sessions of the American Diabetes Association (ADA); June 21-24, 2024; Orlando, FL, USA.
5Rosenstock J, Tofe S, Wysham C, et al. Near-normoglycemia and insulin regression associated with tirzepatide in basal insulin-treated type 2 diabetes. Poster presented at: 84th Annual Scientific Sessions of the American Diabetes Association (ADA); June 21-24, 2024; Orlando, FL, USA.
Appendix
Baseline Demographics and Clinical Characteristics of Participants in SURPASS-6
Parametera |
TZP 5 mg |
TZP 10 mg |
TZP 15 mg |
Pooled TZPb |
Insulin Lispro |
Age, years |
58.0±10.2 |
59.6±9.4 |
58.2±9.6 |
58.6±9.8 |
59.0±9.7 |
Female, n (%) |
144 (59.3) |
149 (62.6) |
133 (56.4) |
426 (59.4) |
396 (55.9) |
Race or ethnic group, n (%)c |
|||||
American Indian or Alaska Native |
0 |
0 |
1 (0.4) |
1 (0.1) |
2 (0.3) |
Asian |
2 (0.8) |
0 |
2 (0.8) |
4 (0.6) |
4 (0.6) |
Black or African American |
11 (4.5) |
9 (3.8) |
11 (4.7) |
31 (4.3) |
26 (3.7) |
Multiple |
0 |
5 (2.1) |
2 (0.8) |
7 (1.0) |
8 (1.1) |
White |
230 (94.7) |
224 (94.1) |
220 (93.2) |
674 (94.0) |
668 (94.4) |
Hispanic or Latino |
148 (60.9) |
142 (59.7) |
149 (63.1) |
439 (61.2) |
443 (62.6) |
HbA1c, %d |
8.89±0.97 |
8.78±0.98 |
8.74±1.01 |
8.80±0.99 |
8.80±0.97 |
>8.5%, n (%) |
146 (60.1) |
133 (55.9) |
132 (55.9) |
411 (57.3) |
407 (57.5) |
FSG, mg/dLe |
163.3±59.2 |
155.8±55.5 |
155.9±54.3 |
158.4±56.4 |
156.3±56.1 |
QD iGlar, median (IQR) |
|||||
IU |
46.0 (36.0-60.0) |
46.0 (34.0-60.0) |
47.0 (36.0-61.0) |
46.0 (36.0-60.0) |
46.0 (36.0-60.0) |
IU/kg |
0.51 (0.41-0.66) |
0.54 (0.41-0.69) |
0.52 (0.41-0.69) |
0.52 (0.41-0.68) |
0.53 (0.42-0.68) |
Diabetes duration, yearsf |
13.4±6.9 |
13.9±7.3 |
13.4±7.6 |
13.6±7.2 |
14.0±7.4 |
BMI, kg/m2 |
33.51±5.30 |
33.35±5.49 |
33.03±5.34 |
33.30±5.37 |
33.00±5.15 |
Weight, kg |
91.7±17.9 |
89.1±18.8 |
91.2±18.7 |
90.7±18.5 |
90.3±17.7 |
eGFR,g mL/min/1.73 m2 |
89.0±20.7 |
89.5±18.0 |
89.3±19.9 |
89.3±19.6 |
88.8±18.8 |
<60 mL/min/1.73 m2, n (%) |
27 (11.1) |
14 (5.9) |
24 (10.2) |
65 (9.1) |
65 (9.2) |
Metformin use, n (%) |
202 (83.1) |
195 (81.9) |
201 (85.2) |
598 (83.4) |
606 (85.6) |
Abbreviations: BMI = body mass index; eGFR = estimated glomerular filtration rate; FSG = fasting serum glucose; HbA1c = glycated hemoglobin; iGlar = insulin glargine; IQR = interquartile range; IU = international units; QD = daily; TZP = tirzepatide.
Note: Safety population included all randomly assigned patients who were exposed to at least 1 dose of study drug.
aData are mean±SD in the safety population unless otherwise indicated.
bData for the 5 mg, 10 mg, and 15 mg groups combined.
cTo meet regulatory requirements, race and ethnicity were recorded in this study and were determined by the participant according to fixed selection categories.
dNormal value for HbA1c was <6.5%.
eNormal value for FSG was 74-106 mg/dL for those younger than 60 years and 82-115 mg/dL for those aged 60-90 years.
fDuration of diabetes was based on the first diagnosis of type 2 diabetes.
geGFR was calculated with the serum creatinine-based Chronic Kidney Disease Epidemiology Collaboration equation. Normal value for eGFR was 60 mL/min/1.73 m2. Participants with a baseline eGFR <30 mL/min/1.73 m2 were excluded from the study.
Date of Last Review: July 22, 2025