EUCTR2019-004234-42-FIActive, not recruitingPhase 1
Effect and safety of two different dose-escalation regimens for once-weekly semaglutide s.c. in subjects with type 2 diabetes mellitus previously treated with GLP-1 RAs - SUSTAIN SWITCH
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 160
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Male or female, age 18 years or older at the time of signing informed consent.
- •- Diagnosed with type 2 diabetes mellitus 180 days or longer prior to the day of screening.
- •- The need and willingness to change prior GLP-1 RA treatment to once-weekly semaglutide s.c., as assessed by the investigator.
- •- HbA1c of 6.5-10% (48-86 mmol/mol) (both inclusive).
- •- Treatment with any therapeutic dose of GLP-1 RA other than once-weekly semaglutide s.c., as defined in the local label, with or without OADs (metformin, DPP-4 inhibitor, SU, glinide, thiazolidinedione, SGLT-2 inhibitor or alpha-glucosidase inhibitor). All doses of antidiabetic treatments should have been stable for at least 90 days prior to the day of the screening, at investigator’s discretion.
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
Exclusion Criteria
- •- 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 below 30 mL/min/1.73 m^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 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
Investigators
Similar Trials
Active, not recruiting
Phase 1
SUSTAIN SWITCH: A research study to compare two dose schedules of semaglutide taken once weekly in people with type 2 diabetesMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 2EUCTR2019-004234-42-ATovo Nordisk A/S160
Active, not recruiting
Phase 1
SUSTAIN SWITCH: A research study to compare two dose schedules of semaglutide taken once weekly in people with type 2 diabetesMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Diabetes Mellitus, Type 2EUCTR2019-004234-42-SEovo Nordisk A/S160
Completed
Not Applicable
Atorvastatin in open heart surgeryCondition 1: Coronary artery bypass graft. Condition 2: Diabet melitus. Condition 3: Atrial fibrilation. Condition 4: Deliriom. Condition 5: Acute myocardial ischemia and infarction.Mechanical complication of coronary artery bypass and valve graftsInsulin-dependent diabetes mellitus-Non-insulin-dependent diabetes mellitusAtrial fibrillation and flutterDelirium, not induced by alcohol and other psychoactive substancesE10-11Acute myocardial infarctionIRCT2012072310311N2Shiraz University of Medical Sciences100
Recruiting
Phase 2
Evaluation of efficacy and safety of dose-escalating lenalidomide and dexamethasone (Ld) therapy and adapted therapy adding elotuzumab with insufficient efficacy by Ld therapy in newly diagnosed, transplant ineligible multiple myeloma patients (DELAYED study)Multiple MyelomaJPRN-UMIN000036377Gifu university hospital33
Not yet recruiting
Not Applicable
A study to compare two different dose-combinations of Propofol(Induction agent)and Ketamine(Induction agent)(Ketofol) as induction agent for patients undergoing surgery under general anaesthesia.CTRI/2020/06/025990Government Mohan Kumaramangalam Medical College and Hospital