Diabetes Mellitus, Type 2, Type 2 Diabetes
Conditions
Brief summary
The main purpose of this study is to investigate the effects of switching from glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy to tirzepatide glucose-dependent insulinotropic polypeptide (GIP) GLP-1 RA agonist in participants with type 2 diabetes (T2D).
Interventions
DRUGTirzepatide
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have Type 2 diabetes (T2D) * Have an HbA1c c ≥6.5% (≥48 mmol/mol) to ≤9.0% (≤75 mmol/mol) * Have a body mass index (BMI) ≥25 kilogram per square meter (kg/m²) at screening * Have been on a stable treatment dose of 1 of the listed GLP-1 RAs for ≥3 months * No treatment with oral antidiabetic medicine (OAM) or on stable doses (for at least 3 months before screening) of up to 3 OAM. The OAM may include metformin, sodium-glucose linked transporter-2 inhibitor (SGLT-2i), thiazolidinediones, or α-glucosidase inhibitors.
Exclusion criteria
* Have Type 1 Diabetes (T1D) * Have a clinical history of * proliferative diabetic retinopathy * diabetic maculopathy, or * non-proliferative diabetic retinopathy that requires acute treatment * Are at high risk for cardiovascular disease or have a history of * myocardial infarction * percutaneous coronary revascularization procedure * carotid stenting or surgical revascularization * nontraumatic amputation * peripheral vascular procedure * cerebrovascular accident * or hospitalization for congestive heart failure * Have New York Heart Association (NYHA) Functional Classification Class IV congestive heart failure * Have a history of ketoacidosis or hyperosmolar state or coma * Have a history of severe hypoglycemia or hypoglycemia unawareness within the 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 12 | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Percentage of Time Per Day That Continuous Glucose Monitoring (CGM)-Derived Values Were >180 Milligram/Deciliter (mg/dl) (10 Millimole/Liter (mmol/L)) | Baseline, Week 4 | Change from Baseline in Percentage of Time per Day that CGM-derived Values were \>180 mg/dl (10 mmol/L) was assessed. |
| Change From Baseline in Percentage of Time Per Day That CGM-derived Values Were >180 mg/dl (10 mmol/L) | Baseline, Week 12 | Change from Baseline in Percentage of Time per Day that CGM-derived Values were \>180 mg/dl (10 mmol/L) was assessed. |
| Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L) | Baseline, Week 4 | Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values were \>180 mg/dl (10 mmol/L) was assessed. |
| Change From Baseline in Fasting Serum Glucose (FSG) | Baseline, Week 12 | Change from Baseline in FSG was assessed. |
| Change From Baseline in Weight | Baseline, Week 12 | Change from Baseline in Weight was assessed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 5 mg Tirzepatide Participants received 5 mg tirzepatide SC administered QW for 12 weeks. | 152 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Early Discontinuation Due to Hyperglycemia | 1 |
| Overall Study | Inadvertent Enrolment | 12 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Participant Moved Out of State | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | 5 mg Tirzepatide |
|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 10.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 120 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hemoglobin A1c (HbA1c) | 7.40 Percentage of HbA1c STANDARD_DEVIATION 0.66 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 117 Participants |
| Region of Enrollment United States | 152 Participants |
| Sex: Female, Male Female | 84 Participants |
| Sex: Female, Male Male | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 152 |
| other Total, other adverse events | 0 / 152 |
| serious Total, serious adverse events | 1 / 152 |
Outcome results
Primary
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Time frame: Baseline, Week 12
Population: All participants who received at least one dose of tirzepatide, had a baseline and had evaluable data for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide | Change From Baseline in Hemoglobin A1c (HbA1c) | -0.43 Percentage of HbA1c | Standard Error 0.05 |
Secondary
Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L)
Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values were \>180 mg/dl (10 mmol/L) was assessed.
Time frame: Baseline, Week 4
Population: All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide | Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L) | -93.82 Minutes per day | Standard Error 22.3 |
Secondary
Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L)
Change from Baseline in Duration of Time in Minutes per Day that CGM derived Values were \>180 mg/dl (10 mmol/L) was assessed.
Time frame: Baseline, Week 12
Population: All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide | Change From Baseline in Duration of Time in Minutes Per Day That CGM Derived Values Were >180 mg/dl (10 mmol/L) | -106.09 Minutes per day | Standard Error 22.21 |
Secondary
Change From Baseline in Fasting Serum Glucose (FSG)
Change from Baseline in FSG was assessed.
Time frame: Baseline, Week 12
Population: All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide | Change From Baseline in Fasting Serum Glucose (FSG) | -7.83 milligrams per deciliter (mg/dL) | Standard Error 2.85 |
Secondary
Change From Baseline in Percentage of Time Per Day That CGM-derived Values Were >180 mg/dl (10 mmol/L)
Change from Baseline in Percentage of Time per Day that CGM-derived Values were \>180 mg/dl (10 mmol/L) was assessed.
Time frame: Baseline, Week 12
Population: All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide | Change From Baseline in Percentage of Time Per Day That CGM-derived Values Were >180 mg/dl (10 mmol/L) | -7.37 Percentage of time per day | Standard Error 1.54 |
Secondary
Change From Baseline in Percentage of Time Per Day That Continuous Glucose Monitoring (CGM)-Derived Values Were >180 Milligram/Deciliter (mg/dl) (10 Millimole/Liter (mmol/L))
Change from Baseline in Percentage of Time per Day that CGM-derived Values were \>180 mg/dl (10 mmol/L) was assessed.
Time frame: Baseline, Week 4
Population: All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide | Change From Baseline in Percentage of Time Per Day That Continuous Glucose Monitoring (CGM)-Derived Values Were >180 Milligram/Deciliter (mg/dl) (10 Millimole/Liter (mmol/L)) | -6.52 Percentage of time per day | Standard Error 1.55 |
Secondary
Change From Baseline in Weight
Change from Baseline in Weight was assessed.
Time frame: Baseline, Week 12
Population: All participants who received at least one dose of tirzepatide, had a baseline and at least one post-baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide | Change From Baseline in Weight | -2.15 kilograms (kg) | Standard Error 0.28 |