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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,002
Administered SC.
Administered SC
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
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
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
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
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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Advanced Research Center
Anaheim, California, United States
Valley Clinical Trials, Inc.
Covina, California, United States
Marin Endocrine Associates
Greenbrae, California, United States
National Research Institute
Huntington Park, California, United States
Scripps Whittier Diabetes Institute
La Jolla, California, United States
First Valley Medical Group
Lancaster, California, United States
National Research Institute
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Monterey Endocrine & Diabetes Institute, Inc.
Monterey, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
...and 206 more locations
Time frame: Baseline, Week 52
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
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
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