A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes
(SWITCH 2 Trial)
Recruiting in Palo Alto (17 mi)
+134 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Novo Nordisk A/S
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is conducted in the United States of America (USA). The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar) with or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides in subjects with type 2 diabetes.
Research Team
GC
Global Clinical Registry (GCR, 1452)
Principal Investigator
Novo Nordisk A/S
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Subjects fulfilling at least one of the below criteria: a) Experienced at least one severe hypoglycaemic episode within last year (according to the ADA (American Diabetes Association) definition, April 2013), b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-Epi (Chronic Kidney Disease Epidemiology Collaboration) by central laboratory analysis, c) Hypoglycaemic symptom unawareness, d) Exposed to insulin for more than 5 years, e) Recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dL [below or equal to 3.9 mmol/L])) within the last 12 weeks prior to Visit 1 (screening) - Type 2 diabetes mellitus (diagnosed clinically) for at least 26 weeks prior to Visit 1 - Current treatment with any basal insulin (OD or BID) ± any combination of OADs (metformin, DPP-4 inhibitor, alpha-glucosidase inhibitor, thiazolidinediones, and SGLT2-inhibitor) for 26 weeks or longer prior to Visit 1 For subjects on BID the total daily dose should be below 75 units - HbA1c (glycosylated haemoglobin) below or equal to 9.5 % by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m^2
Treatment Details
Interventions
- Insulin Degludec (Long-acting insulin)
- Insulin Glargine (Long-acting insulin)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: IDeg OD ± OADs followed by IGlar OD ± OADsExperimental Treatment2 Interventions
The trial includes two 32-week treatment periods in a cross-over design. Total trial duration for the individual subjects will be up to 67 weeks.
Group II: IGlar OD ± OADs followed by IDeg OD ± OADsActive Control2 Interventions
The trial includes two 32-week treatment periods in a cross-over design. Total trial duration for the individual subjects will be up to 67 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Novo Nordisk Investigational SitePembroke Pines, FL
Novo Nordisk Investigational SiteTampa, FL
Novo Nordisk Investigational SiteChampaign, IL
Novo Nordisk Investigational SiteChicago, IL
More Trial Locations
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Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Trials
1578
Patients Recruited
3,813,000+