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: EUCTR
• Last refreshed on: 22 August 2016
• Main ID: EUCTR2013-004392-12-SI
• Date of registration: 13/02/2014
• 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
• 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 – vs. Basal Insulin
• Date of first enrolment: 28/04/2014
• Target sample size: 1047
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004392-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Croatia, European Union, Germany, India, Macedonia, the former Yugoslav Republic of, Mexico, Netherlands, Romania, Slovakia, Slovenia, South Africa, United Kingdom, United States

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female, age =18 years at the time of signing informed consent
2. Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin =1500 mg or maximum tolerated dose and SU = 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
3. HbA1c 7.0 – 10.0% (53 - 86 mmol/mol) both inclusive
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 838
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 209

Exclusion criteria:
1. 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
2. Any disorder which, in the opinion of the Investigator might jeopardise subject’s safety or compliance with the protocol
3. 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 in total) with insulin in connection with intercurrent illness
4. History of chronic or idiopathic acute pancreatitis
5. Screening calcitonin value =50 ng/L
6. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
7. Severe renal impairment defined as eGFR <30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
8. Acute coronary or cerebrovascular event within 90 days before randomisation
9. Heart failure, New York Heart Association Class IV
10. Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
11. Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
12. Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Diabetes Mellitus, Type 2
MedDRA version: 16.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Intervention(s)

Product Name: Semaglutide B 1.34 mg/ml PDS290
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: SEMAGLUTIDE
CAS Number: 910463-68-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1.34-
Pharmaceutical form of the placebo: Solution for injection in pre-filled pen
Route of administration of the placebo: Subcutaneous use

Trade Name: Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337-95-1
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): Change in HbA1c

Secondary Objective: To compare the effects of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily after 30 weeks of treatment on:
- Inducing and maintaining weight loss
- Other parameters of efficacy, safety, tolerability and patient reported outcomes

Main Objective: To compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes

Timepoint(s) of evaluation of this end point: From baseline to week 30

Secondary Outcome(s)

Secondary end point(s): 1. Change in body weight
2. Change in fasting plasma glucose (FPG)
3. Change in systolic and diastolic blood pressure
4. Change in patient reported outcome questionnaires (PROs), SF-36v2™ and DTSQs
5. Subjects who achieve HbA1c =6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE)
target (yes/no)

Timepoint(s) of evaluation of this end point: 1.- 4. From baseline to week 30
5. After 30 weeks' treatment

Secondary ID(s)

NN9535-3625

Source(s) of Monetary Support

Novo Nordisk A/S