The main purpose of this study is to investigate the efficacy and safety of Tirzepatide monotherapy in Chinese participants with Type 2 Diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
206
Administered SC
Administered SC
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 calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Treatment (Type III sum of squares) as variables.
Time frame: Baseline, Week 40
Percentage of Participants With HbA1c Target Values of <7.0% (<53 Millimole/Mole [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 mmol/mol) is reported here.
Time frame: Week 40
Change From Baseline in Fasting Serum Glucose
LS mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment (Type III sum of squares) as variables.
Time frame: Baseline, Week 40
Percentage of Participants With HbA1c Target Values of ≤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 ≤6.5% (≤48 mmol/Mol) is reported here.
Time frame: Week 40
Change From Baseline in Body Weight
LS mean was calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment (Type III sum of squares) as variables.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Shunde Hospital of Southern Medical Univesity
Foshan, Guangdong, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
Zunyi First People's Hospital
Zunyi, Guizhou, China
Hainan General Hospital
Haikou, Hainan, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Yichang Central People's Hospital
Yichang, Hubei, China
...and 18 more locations
Time frame: Baseline, Week 40
Percentage of Participants With HbA1c Target Values of <5.7% (<39 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 \<5.7% (\<39 mmol/mol) is reported here.
Time frame: Week 40
Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
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 mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + Baseline HbA1c (\<=8.5%, \>8.5%) + Prior Antihyperglycemic Use + Treatment + Time + Treatment\*Time(Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.
Time frame: Baseline, Week 40
Percentage of Participants Who Achieved Weight Loss of ≥5%
Percentage of Participants who Achieved Weight Loss ≥5% is reported here.
Time frame: Week 40
Percentage of Participants Who Achieved Weight Loss of ≥10%
Percentage of Participants who Achieved Weight Loss ≥10% is reported here.
Time frame: Week 40
Percentage of Participants Who Achieved Weight Loss of ≥15%
Percentage of Participants who Achieved Weight Loss ≥15% is reported here.
Time frame: Week 40