Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Utreglutide (GL0034) Solution for Injection: Utreglutide (GL0034): 0.375 mg, 0.75 mg, 1.5 mg and 3 mg
Control Intervention1: Tirzepatide Injection: Tirzepatide: 5 mg
Sponsors
Sun Pharmaceutical Industries Limited (SPIL)
Sun Pharmaceutical Industries Limited SPIL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender, aged 18 to 65 years (both inclusive). 2. Voluntarily willing to provide written informed consent to participate in the study. 3. Patients with diagnosis of T2DM at least 180 days prior to screening and have glycated hemoglobin (HbA1c) levels 7.0% to 10.5% (both inclusive) at screening visit. 4. Patients with BMI 23 to 45 kg/m2 (both inclusive) at screening. 5. Female patient as woman of childbearing potential (WOCP), must have a negative serum pregnancy test at Screening, negative urine pregnancy test at Randomization and at subsequent visits and she must agree to use a highly effective method of contraception during the study in conjunction with a barrier method of contraception, and continue the same contraception method till end of study. Highly effective methods of contraception include one of the following: intrauterine device, injectable hormonal contraceptive, contraceptive patch or implant, partner s vasectomy, bilateral tubal occlusion, and sexual abstinence. 6. Male patients with female partners of child-bearing potential must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy) during the study. In addition, male patients agree to use the same method of contraception till end of study and refrain from donating sperm during this period. In the event that the female partner of the male patients becomes pregnant during the study period to till end of study, written informed consent will be obtained from the female partner in order to monitor the female partner, pregnancy, and the new born.
Exclusion criteria
Exclusion criteria: 1) Patients with history of hypersensitivity to any of the known allergies to Glucagon Like Peptide-1 (GLP-1) analogues, Glucose-dependent Insulinotropic Polypeptide (GIP) + GLP-1 analogues, glucagon, or related compounds, or its excipients or to drugs of similar chemical classes. 2) Patients diagnosed with type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes/obesity (such as but not limited to Cushing syndrome or acromegaly-associated diabetes or corticosteroid induced diabetes). 3) Patients with Fasting Blood Glucose (FBG) more than equal to 270 mg/dL at screening. 4) Treatment with any medication for diabetes 90 days or less before screening (other than metformin, or short-term insulin [less than equal to 14 days treatment]). 5) Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC) 6) Serum Calcitonin level more than equal to 20 ng/L (pg/mL) at screening. 7) Patient with any of the cardiovascular condition (including but not limited to): Uncontrolled cardiac arrhythmia or Confirmed QT interval corrected using Fridericia s formula (QTcF) more than 450 msec for males and more than 470 msec for females at the Screening and randomization. high-degree atrioventricular block) within last 6 months prior to screening visit. New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction less than 30% Patients with percutaneous coronary intervention, coronary artery bypass graft, stroke, venous thromboembolism or transient ischemic attack within 6 months prior to screening; Patients are taking, or will start medications with narrow therapeutic index, such as digoxin, warfarin etc. Patients who are on concomitant QTc prolonging drugs to those that are at stable doses at screening or who require initiation of new concomitant QTc prolonging drugs during the study. Patients with history of hospitalization for unstable angina, within the past 6 months prior to the day of screening. Patients who require planned coronary, carotid or peripheral artery revascularisation known on the day of screening. 8) History of pancreatitis (acute or chronic) or symptomatic or known gallbladder disease. 9) Patients with known clinically significant gastric emptying abnormality (such as diabetic gastroparesis). 10) History of any form of depression, severe psychiatric illnesses (i.e. schizophrenia, bipolar disorder) or any lifetime history of a suicidal attempt. 11) History or presence of malignant neoplasms within the last 5 years before screening. 12) Patients with cataract, diabetic retinopathy or maculopathy diagnosed on fundoscopy examination.. 13) Patient with positive results of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) at screening visit. 14) Any condition (e.g., infection, trauma, and surgery) which require insulin therapy at the time of screening or during the study period. 15) Patients with any clinically significant laboratory abnormalities/condition (such as but not limited to cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, psychiatric, genetic neurological disorders, acute infections or diseases capable of significantly altering the absorption, metabol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in HbA1c to Week 24Timepoint: [Timeframe: Baseline, Week 24] | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving HbA1c of less than 5.7%, less than 6%, less than 6.5% and less than 7.0%Timepoint: [Timeframe: Baseline and up-to week 28];Change from Baseline in HbA1c levelsTimepoint: [Timeframe: Baseline and up-to week 28];Change from Baseline in postprandial blood glucose (PPBG) levelsTimepoint: [Timeframe: Baseline and up-to week 28];Change from Baseline in Fasting blood glucose (FBG) levelsTimepoint: [Timeframe: Baseline and up-to week 28];Change and Percentage change from baseline in body weight (Kg), BMI, waist circumference and hip circumference.Timepoint: [Timeframe: baseline and up-to week 28];Change from Baseline in waist to hip ratio (WHR)Timepoint: [Timeframe: baseline and up-to week 28];Proportion of patients with more than equal to 5%, more than equal to10% and more than equal to 15% body weight lossTimepoint: [Timeframe: up-to week 28];8. Mean and Percent (%) change in lipid profile (total cholesterol level, High density lipoprotein (HDL) level, Low density lipoprotein (LDL) level, Very low density lipoprotein (VLDL) level, triglycerides level, chylomicrons level, free fatty acids, lipoprotein A [Lp(a)], LDL/HDL ratio)Timepoint: [Timeframe: baseline and up-to week 28];Change in SF-36Timepoint: [Timeframe: Baseline, and at week 24];Change in subjective rating of appetite sensations measured by visual analogue scaleTimepoint: [Timeframe: Baseline and at week 24];Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent -Adverse Events of Special Interest (TE-AESI) and serious adverse events (SAEs)Timepoint: [Timeframe: Throughout the study period];Proportion of patients received hypoglycaemia managementTimepoint: [Timeframe: Throughout the study period];Proportion of patients received rescue medicationsTimepoint: [Timeframe: Throughout the study period];Proportion of patients with anti-drug antibodies (ADA) and neutralizing antibody (NAb)Timepoint: [Timeframe: up-to week 28] | — |
Countries
India
Contacts
Public ContactChaitali Bornare
Sun Pharma Laboratories Limited
Outcome results
None listed