The main reason for this study is to compare the study drug tirzepatide to insulin glargine in participants with type 2 diabetes on metformin with or without a sulfonylurea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
917
Administered SC
Administered SC
Mean 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 with covariates Baseline + Country + Baseline Oral Antihyperglycemic Medication (OAM) Use (Metformin (Met), Met plus Sulfonylurea (SU)) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Time frame: Baseline, Week 40
Mean 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 with covariates Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Time frame: Baseline, Week 40
Mean Change From Baseline in Body Weight
LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\<= 8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as covariates.
Time frame: Baseline, Week 40
Percentage of Participants Achieving an HbA1c Target Value of <7.0%
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured 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 40
Percentage of Participants Achieving an HbA1c Target Value of <5.7%
HbA1c is the glycosylated fraction of hemoglobin A. Imputed data includes observed value and imputed value if endpoint measure is missing.
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Paratus Clinical Research Western Sydney
Blacktown, New South Wales, Australia
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
Illawarra Shoalhaven Local Health District
Wollongong, New South Wales, Australia
Core Research Group
Milton, Queensland, Australia
Barwon Health - The Geelong Hospital
Geelong, Victoria, Australia
Adelaide Medical Solutions
Woodville South, Australia
Peking University People's Hospital
Beijing, Beijing Municipality, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
Cangzhou People's Hospital
Cangzhou, Hebei, China
...and 57 more locations
Time frame: Week 40
Mean 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 with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\<= 8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as covariates.
Time frame: Baseline, Week 40
Mean Change in Daily Glucose Average From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values
The SMBG data was 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. LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\<= 8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as covariates.
Time frame: Baseline, Week 40
Percentage of Participants Who Achieved Weight Loss ≥5%
Imputed data includes observed value and imputed value if endpoint measure is missing.
Time frame: Week 40
Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score
DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 40 or early termination. The treatment satisfaction score ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS mean was determined by ANCOVA model for endpoint measures with Baseline + Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline OAM Use (Met, Met plus SU) + Treatment (Type III sum of squares) as covariates.
Time frame: Baseline, Week 40
Rate of Hypoglycemia With Blood Glucose < 54 mg/dL or Severe Hypoglycemia
The hypoglycemia events were defined by participant reported events with blood glucose \< 54 mg/dL \[\<3.0 Millimole per Liter (mmol/L)\] 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. The rate of post-baseline hypoglycemia was estimated by negative binomial model: Number of episodes = Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (\<= 8.5%, \>8.5%) + Treatment, with log (exposure in days/365.25) as an offset variable.
Time frame: Baseline through end of safety follow-up (Up To Week 44)