Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Semaglutide: 3mg, 7mg and 14mg
Once a day (OD)
Oral. Duration of treatment is 52 weeks.
Control Intervention1: Placebo: 3mg, 7mg and 14mg
Once a day (OD)
Oral. Duration of treatment is
Sponsors
Novo Nordisk India private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects are eligible to be included in the trial only if all of the following criteria apply. 1.Informed consent from parents or legally acceptable representative LAR and child assent from the subject obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial including activities to determine suitability for the trial. 2.Male or female aged 10 to less than 18 years at the day of randomisation. 3.Diagnosed with type 2 diabetes mellitus according to the ADA criteria and treated with 1.stable metformin dose or 2.stable metformin dose and a stable dose of basal insulin or 3.stable dose of basal insulin stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 56 days or longer prior to screening. stable dose of basal insulin is defined as basal insulin treatment greater than or equal to 30 days prior to screening compared to the dose at screening dose adjustments of plus or minus 25 percentage are allowed. 4.HbA1c 6.5 percentage to 11.0 percentage 47 to 97 mmol or mol both inclusive. 5.Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol.
Exclusion criteria
Exclusion criteria: Subjects are excluded from the trial if any of the following criteria apply: 1. Known or suspected hypersensitivity to trial product(s) or related products. 2. Previous participation in this trial. Participation is defined as randomisation. Re-screening is allowed, however there must be at least 90 days between screenings. 3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods, refer to Appendix 5. 4. Receipt of any investigational medicinal product within 30 days before screening. 5. Any disorder, which, in the opinion of the investigator, might jeopardise subjectâ??s safety or compliance with the protocol. 6. Any laboratory safety parameter at screening outside the below extended laboratory ranges: • ALT >=5 times the upper normal limit (UNL) • ALT >=3 times the UNL and bilirubin >=1.5 times the UNL • Creatinine >UNL for age in children unless renal function is proven normal by further assessments at the discretion of the investigator • C-peptide • calcitonin >=50 ng/L 7. Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. 8. History or presence of pancreatitis (acute or chronic). 9. Known history of heart disease (including history of clinically significant arrhythmias or conduction delays on ECG) within 180 days of visit 1, new clinically significant arrhythmias or conduction delays on ECG identified at visit 1. 10. Known hypoglycaemic unawareness as indicated by the investigator according to Clarkeâ??s questionnaire question 83. 11. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator. 12. Uncontrolled hypertension, treated or untreated, >99th percentile for age and gender in children and adolescents. If â??white coat hypertension ? is suspected at visit 1 a repeat blood pressure measurement either during visit 1 or at visit 2 prior to other trial related activities is allowed, with the last measurement being conclusive. 13. Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria in a period of 90 days before screening. However, short-term treatment with bolus insulin for a metabolic decompensation/intercurrent illness for a maximum of 14 days prior to the day of visit 1 is allowed. 14. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy documented by an ophthalmologic examination of the retina preferably supported by a fundus photography or optical coherence tomography within the past 90 days prior to screening or in the period between screening and randomisation (visit 2). Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. 15. Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed. 16. Diagnosis of type 1 diabetes 17. Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies. 18. Maturity ons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c) (%-point and mmol/mol) Timepoint: Week 0 to Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose (FPG) (mmol/L) Timepoint: Week 0 to Week 26 ;Body mass index (BMI) standard deviation score (SDS) Timepoint: Week 0 to Week 26 ;"HbA1c (%-point and mmol/mol) FPG (mmol/L) BMI SDS " Timepoint: at week 52 ;"Body weight (kg), Body weight (relative change, %) Waist circumference (cm) BMI percentile (age and gender adjusted) (%) Systolic and diastolic blood pressure (mmHg)" Timepoint: Week 0 to Week 26 | — |
Countries
Australia, Austria, Belgium, Czech Republic, Greece, India, Israel, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Portugal, Romania, Russian Federation, Taiwan, Ukraine, United Kingdom, United States of America
Contacts
Public ContactDr Maya Sharma
Novo Nordisk India private Ltd
Outcome results
None listed