Diabetes 

Recruitment status:

Recruiting

Primary Sponsor:

Novo Nordisk AS

Recruitment countries:

Argentina, Croatia, France, Germany, India, Mexico, Netherlands, Romania, Slovakia, Slovenia, South Africa, The former Yugoslav Republic of Macedonia, United Kingdom, United States of America

Health condition studied:

Diabetes Type 2

URL:

Link to the clinical trial website

About the trial

Interventions:

Intervention1: Semaglutide 0.5mg/week: Injected Subcutaneously;once weekly;following 4 dosesof 0.25 mgsemaglutide weeklysubjects will receive0.5 mg semaglutide weekly for 26 weeks
Intervention2: Semaglutide 1.0mg/week: Injected Subcutaneously;once weekly;following 4 dosesof 0.25 mg semaglutide weekly and 4 dosesof 0.5 mg semaglutide subjects will receive 1.0 mg semaglutide weekly for 22 weeks
Control Intervention1: Insulin Glargine: Injected Subcutaneously once daily.Subjects will start with 10IU once daily and the dose will be adjusted according to the fasting plasma glucose-duration 30 weeks

Key inclusion and exclusion criteria:

• Inclusion criteria: -Male or female, age â?¥18 years at the time of signing informed consent <br/ >
  -Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with <br/ >
  metformin or metformin and SU (metformin â?¥1500 mg or maximum tolerated dose and SU â?¥ half of maximum allowed dose according to national label) for at least 90 days before screening.Stable is defined as unchanged medication and unchanged dose <br/ >
  -HbA1c 7.0 â?? 10.0% (53 - 86 mmol/mol) both inclusive
• Exclusion criteria: -Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing <br/ >
  potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period. <br/ >
  -Any disorder which, in the opinion of the investigator might jeopardise subjectâ??s safety or <br/ >
  compliance with the protocol <br/ >
  -Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a <br/ >
  period of 90 days before screening. An exception is short-term treatment (â?¤7 days in total) with <br/ >
  insulin in connection with intercurrent illness <br/ >
  -History of chronic or idiopathic acute pancreatitis <br/ >
  -Screening calcitonin value â?¥50 ng/L <br/ >
  -Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome 2 (MEN2) <br/ >
  -Acute coronary or cerebrovascular event within 90 days before randomisation <br/ >
  -Heart failure, New York Heart Association Class IV <br/ >
  -Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator. <br/ >
  -Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or <br/ >
  squamous cell skin cancer) <br/ >
  -Mental inability, unwillingness or language barrier precluding adequate understanding of or <br/ >
  compliance with study procedures <br/ >
  

• Age minimum:
• Age maximum:
• Gender:

Primary outcomes:

Change in HBA1C from baselineTimepoint: week 0 and week 30

Secondary outcomes:

Change in <br/ >
Body weight,Fasting plasma glucose (FPG),Self-measured plasma glucose,Systolic and diastolic blood pressure,Patient reported outcomes,Timepoint: week 0 and week 30
Subjects who after 30 weeks treatment achieveTimepoint: week 0 and week 30

Target sample size:

1047

Study type:

Interventional

Study design:

Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label

Contacts:

• Name: Dr Raman Shetty
• Address: Plot No.32, 47 - 50 EPIP Area, Whitefield
• Phone: 918040303200
• Email: rasy@novonordisk.com
• Affiliation: Novo Nordisk India Private Ltd

• Name: Mr Avik Kumar Gosh
• Address: Plot No.32, 47 - 50 EPIP Area, Whitefield Bangalore KARNATAKA India
• Phone: 918040303200
• Email: rasy@novonordisk.com
• Affiliation: Novo Nordisk India Private Ltd

Technical details

Scientific title:

Efficacy and safety of semaglutide once weekly versus insulin glargine once daily as add on to metformin with or without sulphonylurea in insulin-naïve subjects with type 2 diabetes - SUSTAIN 4

Sources of monetary support:

Novo Nordisk AS

Secondary sponsors:

Main ID:

CTRI/2014/09/005033

Secondary ID:

2013-004392-12
NN9535 3625ver 2.0 dated 05 Feb 2025
U1111-1146-0211

Register:

CTRI

Date of registration:

18-09-2024

Date of first enrollment:

22-09-2024

Last refreshed:

7 November 2024