| Primary | Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [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 calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + SGLT2i Use (Yes/No) + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured | All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication. | Posted | | Least Squares Mean | Standard Error | millimoles per mole (mmol/mol) | | Baseline, Week 40 | | | | ID | Title | Description |
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| OG000 | 10 mg Tirzepatide | Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached. | | OG001 | 15 mg Tirzepatide | Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached. | | OG002 | Placebo | Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-26.1± 1.367
- OG001-25.9± 1.386
- OG002-9.96± 1.340
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Mixed Models Analysis | | <0.001 | | LS Mean Difference | -16.1 | | | 2-Sided | 95 | -19.9 | -12.36 | | | | | Superiority | | | | | Mixed Models Analysis | | <0.001 |
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| Secondary | Mean Change From Baseline in HbA1c (Tirzepatide 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 calculated using MMRM for post-baseline measures: Variable = Baseline + SGLT2i Use (Yes/No) + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured | All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication. | Posted | | Least Squares Mean | Standard Error | mmol/mol | | Baseline, Week 40 | | | | ID | Title | Description |
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| OG000 | 5 mg Tirzepatide | Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached. | | OG001 | Placebo | Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks. |
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| Secondary | Mean Change From Baseline in Body Weight | LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (<=8.0%, >8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured | All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication. | Posted | | Least Squares Mean | Standard Error | kilograms (kg) | | Baseline, Week 40 | | | | ID | Title | Description |
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| OG000 | 5 mg Tirzepatide | Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached. | |
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| Secondary | Percentage of Participants With HbA1c <7.0% (53 Millimole/Mole [mmol/Mol]) and ≤6.5% (48 mmol/Mol) | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of Participants with HbA1c <7.0% (53 millimole/mole [mmol/mol]) and ≤6.5% (48 mmol/mol) is reported here. | All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication. | Posted | | Number | | percentage of participants | | Week 40 | | | | ID | Title | Description |
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| OG000 | 5 mg Tirzepatide | Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached. |
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| Secondary | Mean Change From Baseline in Fasting Serum Glucose | LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (<=8.0%, >8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured | All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication. | Posted | | Least Squares Mean | Standard Error | milligram per deciliter (mg/dL) | | Baseline, Week 40 | | | | ID | Title | Description |
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| OG000 | 5 mg Tirzepatide | Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached. | |
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| Secondary | Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 10 mg or 15 mg] | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentage of participants with HbA1c <5.7% (39 mmol/Mol) is reported here. | All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication. | Posted | | Number | | percentage of participants | | Week 40 | | | | ID | Title | Description |
|---|
| OG000 | 10 mg Tirzepatide | Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached. | | OG001 | 15 mg Tirzepatide | Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached. | | OG002 |
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| Secondary | Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 5 mg] | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentage of participants with HbA1c <5.7% (39 mmol/Mol) is reported here. | All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication. | Posted | | Number | | percentage of participants | | Week 40 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Tirzepatide | Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached. | | OG001 | Placebo | Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks. |
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| Secondary | Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles | The SMBG data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS Mean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (<=8.0%, >8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured. | All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication. | Posted | | Least Squares Mean | Standard Error | millimoles per liter per day(mmol/L/day) | | Baseline, Week 40 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Tirzepatide | Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached. | | OG001 | 10 mg Tirzepatide | |
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| Secondary | Percentage of Participants Who Achieved Weight Loss of ≥5% | Percentage of Participants who Achieved Weight Loss ≥5% is reported here. | All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication. | Posted | | Number | | percentage of participants | | Week 40 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Tirzepatide | Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached. |
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| Secondary | Percentage of Participants Who Achieved Weight Loss of ≥10% | Percentage of Participants who Achieved Weight Loss ≥10% is reported here. | All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication. | Posted | | Number | | percentage of participants | | Week 40 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Tirzepatide | Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached. |
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| Secondary | Percentage of Participants Who Achieved Weight Loss of ≥15% | Percentage of Participants who Achieved Weight Loss ≥15% is reported here. | All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication. | Posted | | Number | | percentage of participants | | Week 40 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Tirzepatide | Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached. | | OG002 | 15 mg Tirzepatide | Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached. |
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| Secondary | Percent Change From Baseline in Daily Mean Insulin Glargine Dose | LS Mean was calculated using MMRM for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Baseline HbA1c (<=8.0%, >8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured. | All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline, Week 40 | | | | ID | Title | Description |
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| OG000 | 5 mg Tirzepatide | Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached. | | OG002 |
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| Secondary | Percentage of Participants With HbA1c <7.0%, Without Weight Gain (<0.1 Kilogram [kg]) and Without Hypoglycemia, (Blood Glucose <3.0 mmol/L <54 Milligram/Deciliter [mg/dL]) | Percentage of Participants with HbA1c <7.0%, Without Weight Gain (<0.1 Kilogram [kg]) and Without Hypoglycemia, (Blood Glucose <3.0 mmol/L <54 Milligram/Deciliter [mg/dL]) is reported here | All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication. | Posted | | Number | | percentage of participants | | Week 40 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Tirzepatide | Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached. | | OG002 |
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| Secondary | Percentage of Participants With HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.0 mmol/L [54 mg/dL]) | Percentage of Participants with HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood glucose <3.0 mmol/L [54 mg/dL]) is reported here. | All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication. | Posted | | Number | | percentage of participants | | Week 40 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Tirzepatide | Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached. | | OG002 | 15 mg Tirzepatide |
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| Secondary | Percentage of Participants With HbA1c <7.0%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia) | Percentage of Participants with HbA1c <7.0%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia) is reported here. | All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication. | Posted | | Number | | percentage of participants | | Week 40 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Tirzepatide | Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached. | | OG002 |
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| Secondary | Percentage of Participants With HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia) | Percentage of Participants with HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia) is reported here. | All randomized participants who received at least one dose of study drug with baseline and post-baseline value at the specified time point for this outcome excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication. | Posted | | Number | | percentage of participants | | Week 40 | | | | ID | Title | Description |
|---|
| OG000 | 5 mg Tirzepatide | Participants received 5 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached. | | OG001 | 10 mg Tirzepatide | Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached. | | OG002 |
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