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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02128932
• Date of registration: 24/04/2014
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public 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
• 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
• Date of first enrolment: August 4, 2014
• Target sample size: 1089
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02128932
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Croatia, France, Germany, India, Macedonia, The Former Yugoslav Republic of, Mexico, Netherlands, North Macedonia, Puerto Rico, Romania, Slovakia, Slovenia, South Africa, United Kingdom, United States

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female, 18 years or older at the time of signing informed consent

- Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment
with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated
dose and SU half of maximum allowed dose according to national label or higher) for at
least 90 days before screening. Stable is defined as unchanged medication and
unchanged dose

- HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive

Exclusion Criteria:

- Female who is pregnant, breast-feeding or intends to become pregnant or of
childbearing 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

- Any disorder which, in the opinion of the Investigator might jeopardise subject's
safety or compliance with the protocol

- Treatment with any glucose lowering agent(s) other than stated in the inclusion
criteria in a period of 90 days before screening. An exception is short-term treatment
(7 days or less in total) with insulin in connection with intercurrent illness

- History of chronic or idiopathic acute pancreatitis

- Screening calcitonin value greater than or equal to 50 ng/L

- Personal or family history of medullary thyroid carcinoma or multiple endocrine
neoplasia syndrome 2

- Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less
than 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4
variable version)

- Acute coronary or cerebrovascular event within 90 days before randomisation

- Heart failure, New York Heart Association Class IV

- Known proliferative retinopathy or maculopathy requiring acute treatment according to
the opinion of the investigator

- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer
or squamous cell skin cancer)

- Mental inability, unwillingness or language barrier precluding adequate understanding
of or compliance with study procedures



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes

Diabetes Mellitus, Type 2

Intervention(s)

Drug: semaglutide

Drug: insulin glargine

Primary Outcome(s)

Change in HbA1c From Baseline [Time Frame: Week 0, week 30]

Secondary Outcome(s)

Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ [Time Frame: Week 0, week 30]

Change in Body Weight From Baseline [Time Frame: Week 0, week 30]

Change in Diastolic Blood Pressure. [Time Frame: Week 0, week 30]

Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs) [Time Frame: Week 0, week 30]

Change in Systolic Blood Pressure. [Time Frame: Week 0, week 30]

Change in Fasting Plasma Glucose From Baseline [Time Frame: Week 0, week 30]

Subjects Who Achieve HbA1c =6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) [Time Frame: After 30 weeks treatment]

Secondary ID(s)

NL47781.018.14

NN9535-3625

2013-004392-12

U1111-1146-0211

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/03/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02128932