A research study to compare two doses of semaglutide taken once weekly in people with type 2 diabetes
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2018-004529-96-CZ
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 964
- Male or female, age 18 years or older at the time of signing informed consent
- Diagnosed with T2D 180 or more days prior to the day of screening
- Glycated haemoglobin (HbA1c) of 8-10 percent (64-86 mmol/mol) (both inclusive)
- Stable daily dose(s) for 90 days prior to the day of screening of any metformin formulations (1500 mg or more or maximum tolerated or effective dose) alone or in combination with sulfonylureas (SU) (half or more of the maximum approved dose according to local label or maximum tolerated or effective dose)
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 771
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 193
- 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, as is prior insulin treatment for gestational diabetes
- Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m2 according to Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) creatinine equation as defined by KDIGO 2012 classification
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish the superior effect of semaglutide s.c. 2.0 mg once-weekly versus semaglutide s.c. 1.0 mg once-weekly on glycaemic control in subjects with T2D, on a background of metformin with or without sulphonylurea (SU) treatment.;Secondary Objective: To compare the effect of semaglutide s.c. 2.0 mg once-weekly versus semaglutide s.c. 1.0 mg once-weekly in subjects with T2D on a background of metformin with or without SU treatment, on body weight, vital signs, hypoglycaemia and general safety and tolerability.;Primary end point(s): Change in HbA1c (%-points);Timepoint(s) of evaluation of this end point: From baseline (week 0) to week 40
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change in body weight (kg)<br>2. Change in fasting plasma glucose (FPG) (mmol/l)<br>3. Change in body mass index (BMI) (kg/m2)<br>4. Change in waist circumference (cm)<br>5. HbA1c less than 7% at week 40 (yes/no)<br>6. HbA1c 6.5% or less at week 40 (yes/no)<br>7. Weight loss 5% or more at week 40 (yes/no)<br>8. Weight loss 10% or more at week 40 (yes/no)<br>9. Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes <br>10. Change in pulse rate (bpm);Timepoint(s) of evaluation of this end point: 1.-4. From baseline (week 0) to week 40<br>5.-8. At week 40<br>9. From first dose to week 40<br>10. From baseline (week 0) to week 40