Efficacy and safety of semaglutide once-weekly versus placebo as add on to SGLT-2i in subjects with type 2 diabetes mellitus.
- Conditions
- Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Diabetes Mellitus, Type 2MedDRA version: 19.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
- Registration Number
- EUCTR2016-000904-27-NO
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 302
- Informed consent 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.
- Male or female, above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age = 20 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus
- HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive)
- Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed dose drug combination) with a stable dose of metformin (= 1500 mg or maximum tolerated dose) or a SU for at least 90 days prior to the day of screening. All medications in compliance with current local label.
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 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).
- Any disorder which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
- Subjects with alanine aminotransferase > 2.5 x upper normal limit.
- Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative.
- History or presence of pancreatitis (acute or chronic).
- History of diabetic ketoacidosis.
- Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening.
- Subjects presently classified as being in New York Heart Association Class IV.
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
- Renal impairment measured as estimated Glomerular Filtration Rate value of eGFR < 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry for serum creatinine measured at screening.
- Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation.
- Presence or history of malignant neoplasms within the past 5 years prior to the day of
screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline to week 30;<br> Main Objective: To compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodiumglucose co-transporter-2 inhibitor monotherapy or in combination with either metformin or<br> sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes.<br> ;<br> Secondary Objective: To compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodiumglucose co-transporter-2 inhibitor monotherapy or in combination with either metformin or<br> sulfonylurea after 30 weeks of treatment in subjects with type 2 diabetes with regards to:<br> - Weight management<br> - Other parameters of effect, safety and patient reported outcomes<br>
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Change in:<br> 1. Body weight (kg)<br> 2. Fasting plasma glucose<br> 3. Systolic and diastolic blood pressure<br> 4. Scores for selected patient reported outcomes: Diabetes Treatment Satisfaction Questionnaire<br><br> 5. Subjects who achieve HbA1c =6.5% (48 mmol/mol), American Association of Clinical Endocrinologists target (yes/no)<br> ;<br> Timepoint(s) of evaluation of this end point: 1. - 4.: From baseline to week 30<br> 5. After 30 weeks' treatment<br>