Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Semaglutide Injection: Semaglutide Injection 2 mg/3 mL (0.68 mg/mL) prefilled pen 4 mg/3 mL (1.34 mg/mL) prefilled pen and 8 mg/3 mL (2.68 mg/mL) supplied by M/s MSN Laboratories Privat
Sponsors
M/s MSN Laboratories Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or female subject greater than 18 to less than 65 years of age who are willing to provide the written informed consent 2 Subject with Type 2 diabetes mellitus for at least 1 year prior to baseline visit 3 Subjects receiving 2 or more Oral hyperglycemic medications (OAMs at stable doses for 12 weeks prior to screening with metformin greater than 1500 mg per day 4 Glycated hemoglobin greater than 8.0% and less than 10.5 percentage 5 Ability and willingness to administer study medication weekly once as injections to abdomen thigh or upper arm 6 Female adult subject who is non pregnant non lactating 7 Female subject participating in a study is capable of bearing children but is using a reliable form of birth control throughout the study as determined by the investigator 8 As determined by the investigator, the subject should be capable and willing to do the following a Perform self monitored blood glucose (SMBG) b Complete subject diaries as instructed c Be receptive to diabetes education d Be able and willing to adhere to the protocol requirements
Exclusion criteria
Exclusion criteria: 1Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation 2Surgical or medical condition that in the judgment of the Investigator or Sponsor could interfere with test product to be used 3Renal system Subject with clinically significant abnormal Renal Function Test parameters Subject with abnormal eGFR less than 30 mL per min per 1.73 m2 Subjects with clinically significant hyponatremia as per blood biochemistry results at screening Subject with clinically significant hyperkalemia and hypokalemia as per blood biochemistry results at screening 4Hepatic system Subject with abnormal Liver Function Test parameters with values more than 2.5 times the upper limit of normal 5 Endocrine system Subject with abnormal Thyroid Function Test Subject with Type 1 Diabetes Mellitus Subject with acute or chronic pancreatitis Calcitonin levels greater than or equal to 100 ng per L at screening 6Cardiovascular system Inadequately treated hypertension systolic greater than or equal to 150 mm Hg or diastolic greater than or equal to 100 mm Hg Subject with history of atrial fibrillation OR sick sinus syndrome OR atrioventricular block II III Grade AVB II III without pacemaker Subject with known case of symptomatic congestive heart failure unstable angina pectoris myocardial infarction percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery sinus node dysfunction and any clinically significant cardiac arrhythmias Subject is a known case of Stroke 7 Cerebrovascular system Subject with cerebrovascular disease 8 Other disease conditions Subject with clinical history of Bronchospastic disorders Subject with medical history of Oncological Conditions for the last 2 years Subject with known case of Epileptic seizures Subject with clinical history of bipolar disorder who are taking lithium etc Subject with history of muscular dystrophy History of non arteritis central retinal vein occlusion or retinopathy 9 Trial related conditions Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent Currently taking prohibited concomitant medication listed and inability unwillingness to discontinue them for the entire study period Suspected inability or unwillingness to comply with the study procedures Women of childbearing potential to use proper contraceptive methods to avoid pregnancy during study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1Changes in HbA1c valueTimepoint: 1Baseline to end of treatment (week 24) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1Changes in HbA1c 2Changes in fasting blood glucose (FBG) compared 3Changes in 2 hours postprandial blood 4Changes in body weight and BMI compared 5Incidence and rate of hypoglycemic episodes. 6The percentage of participants reaching HbA1c target of 7 % 7Proportion of participants receiving rescue medications Timepoint: 1from baseline after 12 weeks visit 5 of treatment 2from baseline to week 4 week 8 week 12 week 16 and week 24 of treatment 3from baseline after 12 weeks visit 5 of treatment 4glucose from baseline to week 4 week 8 week 12 week 16 and week 24 of treatment 5from baseline to 12 weeks 24 weeks of treatment. 6week 12 and week 24 7Baseline through Week 24 | — |
Countries
India
Contacts
Public ContactMr Chandu Gangadhar Devanpally
MSN Laboratories Pvt Ltd
Outcome results
None listed