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

Conditions: Diabetes Mellitus, Type 2
MedDRA version: 17.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2013-004392-12-DE

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1047

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. Germany: Only highly effective methods of birth control are accepted (ie one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or sexual abstinence or vasectomised partner.
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) Germany: Moderate renal impairment defined as eGFR <60 mL/min/1.73 m^2 per MDRA 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;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:<br>- Inducing and maintaining weight loss<br>- Other parameters of efficacy, safety, tolerability and patient reported outcomes;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline to week 30

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change in body weight<br>2. Change in fasting plasma glucose (FPG)<br>3. Change in systolic and diastolic blood pressure<br>4. Change in patient reported outcome questionnaires (PROs), SF-36v2™ and DTSQs<br>5. Subjects who achieve HbA1c =6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE)<br>target (yes/no);Timepoint(s) of evaluation of this end point: 1.- 4. From baseline to week 30<br>5. After 30 weeks' treatment

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