Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Tirzepatide: 10 mg Tirzepatide
10 mg Tirzepatide administered subcutaneously (SC)
15 mg Tirzepatide
15 mg Tirzepatide administered SC
Control Intervention1: Placebo: Placebo administe
Sponsors
Eli Lilly and Company India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Have Type 2 Diabetes (T2DM) with HbA1c =7% to =10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs) 2. Have a BMI of =27 kg/m² 3. Are overweight or have obesity 4. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight 5. Are at least 18 years of age and age of majority per local laws and regulations
Exclusion criteria
Exclusion criteria: 1. Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM 2. Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values >270 mg/dL(on 2 nonconsecutive days) prior to Visit 3 3. Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment 4. Have self-reported change in body weight >5kg within 3 months prior to screening 5. Have had a history of chronic or acute pancreatitis 6. Change in body weight greater than 5 kg within 3 months prior to starting study 7. Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity 8. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) 9. History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years 10. Any lifetime history of a suicide attempt
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Randomization in Body Weight Percentage of Participants Who Achieve =5% Body Weight Reduction from RandomizationTimepoint: Randomization, 72 Weeks 72 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of Participants Who Achieve =10% Body Weight Reduction from Randomization 2.Percentage of Participants Who Achieve =15% Body Weight Reduction from Baseline 3.Percentage of Participants who Achieve HbA1c less than 7% 4.Percentage of Participants Who Achieve HbA1c =6.5% 5.Percentage of Participants Who Achieve HbA1c less than 5.7% Timepoint: 72 weeks;1.Change from Randomization in Absolute Body Weight 2.Change from Randomization in Body Mass Index 3.Change from Randomization in HbA1c 4.Change from Randomization in Fasting Glucose 5.Change from Randomization in Waist Circumference 6.Change from Randomization in Total Cholesterol 7.Change from Randomization in Low Density Lipid (LDL) Cholesterol 8.Change from Randomization in High Density Lipid (HDL) Cholesterol 9.Change from Randomization in Very Low Density Lipid (VLDL) Cholesterol 10.Change from Randomization in Triglycerides 11.Change from Randomization in Free Fatty Acids 12.Change from Randomization in Systolic Blood Pressure (SBP) 13.Change from Randomization in Diastolic Blood Pressure (DBP) 14.Change from Randomization in Fasting Insulin 15.Change from Randomization in Short Form 36 Health Survey version 2 acute form Physical Functioning domain score Timepoint: Randomization, 72 Weeks;16.Change from Randomization in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL Lite-CT) Physical Function Composite ScoreTimepoint: Randomization, 72 Weeks;Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of TirzepatideTimepoint: Baseline through Week 72 | — |
Countries
Argentina, Brazil, India, Japan, Mexico, Russian Federation, Taiwan, United States of America
Contacts
Public ContactDr Rajeev Sharan Shrivastava
Eli Lilly and Company (India) Pvt. Ltd
Outcome results
None listed