Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to determine the long-term safety of the study drug tirzepatide in combination with oral antihyperglycemic medications in participants with type 2 diabetes.
Interventions
DRUGTirzepatide
Administered SC
DRUGOral antihyperglycemic medication (OAM)
Oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participant must: * Have been diagnosed with type 2 diabetes mellitus based on the World Health Organization classification before the screening visit. * Have HbA1c ≥7.0% to \<11.0%, as determined by the central laboratory at screening. * Have been taking sulfonylureas, biguanides, thiazolidinedione, alpha-glucosidase inhibitor, glinides, or sodium-glucose cotransporter type 2 inhibitor monotherapy for at least 3 months before screening and have been on the following dose for at least 8 weeks before screening. * Have body mass index (BMI) of ≥23 kilograms per meter squared at screening. * Be of stable weight (±5%) during 3 months preceding screening; and agree to not initiate an intensive diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment.
Exclusion criteria
Participant 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 weight loss drugs, including over-the-counter medications during the last 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Week 52 | An SAE is any AE from this study that results in one of the following outcomes: * Death * Initial or prolonged inpatient hospitalization * A life-threatening experience (that is, immediate risk of dying) * Persistent or significant disability/incapacity * Congenital anomaly/birth defect. * Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve HbA1c <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. |
| Change From Baseline in Fasting Serum Glucose | Baseline, Week 52 | Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares). |
| 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 analysis of covariance (ANCOVA) model for endpoint measures: Variable = Baseline + OAM Group 1 + Treatment (Type III sum of squares). |
| Change From Baseline in Body Weight | Baseline, Week 52 | LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares). |
| Percentage of Participants Who Achieve Weight Loss of ≥5% From Baseline | Week 52 | Percentage of Participants who Achieve Weight Loss of ≥5% from Baseline |
| Change From Baseline in Hemoglobin A1c (HbA1c) | 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 + oral antihyperglycemic medication (OAM) Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares). |
| Change From Baseline in Fasting C-Peptide | Baseline, Week 52 | LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares). |
| Change From Baseline in Homeostasis Model Assessment B (HOMA-2B) (Insulin) | Baseline, Week 52 | The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S). LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares). |
| Change From Baseline in HOMA-2S (Insulin) | Baseline, Week 52 | The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S). LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares). |
| Number of Participants With Hypoglycemia Incidence and Rate With Blood Glucose <54 mg/dL or Severe Hypoglycemia, Exclude Hypoglycemic Events Occurring After Initiation of a New Antihyperglycemic Therapy | Baseline through 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. |
| Number of Participants With Anti-Tirzepatide Antibodies | Baseline through Week 52 | Number of Participants with Anti-Tirzepatide Antibodies |
| Change From Baseline in Fasting Insulin | Baseline, Week 52 | LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 5 mg Tirzepatide 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor. | 148 |
| 10 mg Tirzepatide 10 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor. | 147 |
| 15 mg Tirzepatide 15 mg tirzepatide administered SC once a week. Participant received the following pre-treatment oral antihyperglycemic medication (OAM): Sulfonylurea, biguanide, alpha-glucosidase inhibitor, thiazolidinedione, glinide, or sodium-glucose cotransporter type 2 inhibitor. | 148 |
| Total | 443 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 5 | 11 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 4 |
Baseline characteristics
| Characteristic | 5 mg Tirzepatide | 10 mg Tirzepatide | 15 mg Tirzepatide | Total |
|---|---|---|---|---|
| Age, Continuous | 57.7 years STANDARD_DEVIATION 11 | 56.9 years STANDARD_DEVIATION 11.2 | 56.5 years STANDARD_DEVIATION 10.4 | 57.0 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 148 Participants | 147 Participants | 148 Participants | 443 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Hemoglobin A1c | 8.53 : Percentage of HbA1c STANDARD_DEVIATION 1.15 | 8.56 : Percentage of HbA1c STANDARD_DEVIATION 1.05 | 8.59 : Percentage of HbA1c STANDARD_DEVIATION 1.09 | 8.56 : Percentage of HbA1c STANDARD_DEVIATION 1.09 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 148 Participants | 147 Participants | 148 Participants | 443 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 148 Participants | 147 Participants | 148 Participants | 443 Participants |
| Sex: Female, Male Female | 29 Participants | 34 Participants | 44 Participants | 107 Participants |
| Sex: Female, Male Male | 119 Participants | 113 Participants | 104 Participants | 336 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 148 | 0 / 147 | 0 / 148 |
| other Total, other adverse events | 109 / 148 | 108 / 147 | 124 / 148 |
| serious Total, serious adverse events | 2 / 148 | 11 / 147 | 11 / 148 |
Outcome results
Primary
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
An SAE is any AE from this study that results in one of the following outcomes: * Death * Initial or prolonged inpatient hospitalization * A life-threatening experience (that is, immediate risk of dying) * Persistent or significant disability/incapacity * Congenital anomaly/birth defect. * Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Baseline through Week 52
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5 mg Tirzepatide | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 Participants |
| 10 mg Tirzepatide | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 1 Participants |
| 15 mg Tirzepatide | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 1 Participants |
Secondary
Change From Baseline in Body Weight
LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide | Change From Baseline in Body Weight | -3.8 Kilograms (kg) | Standard Error 0.51 |
| 10 mg Tirzepatide | Change From Baseline in Body Weight | -7.5 Kilograms (kg) | Standard Error 0.51 |
| 15 mg Tirzepatide | Change From Baseline in Body Weight | -10.2 Kilograms (kg) | Standard Error 0.52 |
Secondary
Change From Baseline in Fasting C-Peptide
LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide | Change From Baseline in Fasting C-Peptide | -0.12 micrograms/litre (ug/L) | Standard Error 0.044 |
| 10 mg Tirzepatide | Change From Baseline in Fasting C-Peptide | -0.28 micrograms/litre (ug/L) | Standard Error 0.04 |
| 15 mg Tirzepatide | Change From Baseline in Fasting C-Peptide | -0.34 micrograms/litre (ug/L) | Standard Error 0.04 |
Secondary
Change From Baseline in Fasting Insulin
LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide | Change From Baseline in Fasting Insulin | 6.2 picomol per liter (pmol/L) | Standard Error 2.68 |
| 10 mg Tirzepatide | Change From Baseline in Fasting Insulin | -4.8 picomol per liter (pmol/L) | Standard Error 2.21 |
| 15 mg Tirzepatide | Change From Baseline in Fasting Insulin | -7.7 picomol per liter (pmol/L) | Standard Error 2.16 |
Secondary
Change From Baseline in Fasting Serum Glucose
Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide | Change From Baseline in Fasting Serum Glucose | -58.6 milligram per Deciliter (mg/dL) | Standard Error 1.75 |
| 10 mg Tirzepatide | Change From Baseline in Fasting Serum Glucose | -71.2 milligram per Deciliter (mg/dL) | Standard Error 1.75 |
| 15 mg Tirzepatide | Change From Baseline in Fasting Serum Glucose | -74.4 milligram per Deciliter (mg/dL) | Standard Error 1.81 |
Secondary
Change From Baseline in Hemoglobin A1c (HbA1c)
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 + oral antihyperglycemic medication (OAM) Group 1 + 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide | Change From Baseline in Hemoglobin A1c (HbA1c) | -2.57 Percentage of HbA1c | Standard Error 0.075 |
| 10 mg Tirzepatide | Change From Baseline in Hemoglobin A1c (HbA1c) | -2.98 Percentage of HbA1c | Standard Error 0.075 |
| 15 mg Tirzepatide | Change From Baseline in Hemoglobin A1c (HbA1c) | -3.02 Percentage of HbA1c | Standard Error 0.077 |
Secondary
Change From Baseline in HOMA-2S (Insulin)
The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S). LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide | Change From Baseline in HOMA-2S (Insulin) | -0.1 Percentage of HOMA-2S | Standard Error 3.37 |
| 10 mg Tirzepatide | Change From Baseline in HOMA-2S (Insulin) | 16.7 Percentage of HOMA-2S | Standard Error 4.23 |
| 15 mg Tirzepatide | Change From Baseline in HOMA-2S (Insulin) | 24.1 Percentage of HOMA-2S | Standard Error 4.66 |
Secondary
Change From Baseline in Homeostasis Model Assessment B (HOMA-2B) (Insulin)
The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S). LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide | Change From Baseline in Homeostasis Model Assessment B (HOMA-2B) (Insulin) | 39.7 percentage of HOMA-2B | Standard Error 2.16 |
| 10 mg Tirzepatide | Change From Baseline in Homeostasis Model Assessment B (HOMA-2B) (Insulin) | 44.9 percentage of HOMA-2B | Standard Error 2.4 |
| 15 mg Tirzepatide | Change From Baseline in Homeostasis Model Assessment B (HOMA-2B) (Insulin) | 49.2 percentage of HOMA-2B | Standard Error 2.6 |
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 analysis of covariance (ANCOVA) model for endpoint measures: Variable = Baseline + OAM Group 1 + Treatment (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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide | Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values | -80.0 mg/dL | Standard Error 1.91 |
| 10 mg Tirzepatide | Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values | -94.1 mg/dL | Standard Error 1.92 |
| 15 mg Tirzepatide | Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values | -96.3 mg/dL | Standard Error 1.99 |
Secondary
Number of Participants With Anti-Tirzepatide Antibodies
Number of Participants with Anti-Tirzepatide Antibodies
Time frame: Baseline through Week 52
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5 mg Tirzepatide | Number of Participants With Anti-Tirzepatide Antibodies | 87 Participants |
| 10 mg Tirzepatide | Number of Participants With Anti-Tirzepatide Antibodies | 82 Participants |
| 15 mg Tirzepatide | Number of Participants With Anti-Tirzepatide Antibodies | 88 Participants |
Secondary
Number of Participants With Hypoglycemia Incidence and Rate With Blood Glucose <54 mg/dL or Severe Hypoglycemia, Exclude Hypoglycemic Events Occurring After Initiation of a New Antihyperglycemic Therapy
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.
Time frame: Baseline through Week 56
Population: All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5 mg Tirzepatide | Number of Participants With Hypoglycemia Incidence and Rate With Blood Glucose <54 mg/dL or Severe Hypoglycemia, Exclude Hypoglycemic Events Occurring After Initiation of a New Antihyperglycemic Therapy | 1 Participants |
| 10 mg Tirzepatide | Number of Participants With Hypoglycemia Incidence and Rate With Blood Glucose <54 mg/dL or Severe Hypoglycemia, Exclude Hypoglycemic Events Occurring After Initiation of a New Antihyperglycemic Therapy | 1 Participants |
| 15 mg Tirzepatide | Number of Participants With Hypoglycemia Incidence and Rate With Blood Glucose <54 mg/dL or Severe Hypoglycemia, Exclude Hypoglycemic Events Occurring After Initiation of a New Antihyperglycemic Therapy | 3 Participants |
Secondary
Percentage of Participants Who Achieve HbA1c <7%
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 mg Tirzepatide | Percentage of Participants Who Achieve HbA1c <7% | 92.57 percentage of participants |
| 10 mg Tirzepatide | Percentage of Participants Who Achieve HbA1c <7% | 97.95 percentage of participants |
| 15 mg Tirzepatide | Percentage of Participants Who Achieve HbA1c <7% | 96.55 percentage of participants |
Secondary
Percentage of Participants Who Achieve Weight Loss of ≥5% From Baseline
Percentage of Participants who Achieve Weight Loss of ≥5% from Baseline
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 mg Tirzepatide | Percentage of Participants Who Achieve Weight Loss of ≥5% From Baseline | 43.92 percentage of participants |
| 10 mg Tirzepatide | Percentage of Participants Who Achieve Weight Loss of ≥5% From Baseline | 70.55 percentage of participants |
| 15 mg Tirzepatide | Percentage of Participants Who Achieve Weight Loss of ≥5% From Baseline | 84.14 percentage of participants |