A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin
Recruiting in Palo Alto (17 mi)
+42 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 confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.
Research Team
GC
Global Clinical Registry (GCR, 1452)
Principal Investigator
Novo Nordisk A/S
Eligibility Criteria
Inclusion Criteria
Type 2 diabetes
Current treatment with once daily insulin glargine in vials with a daily dose equal to or above 65 U and equal to or below 100 U
Current treatment with a stable dose of metformin plus/minus one additional oral antidiabetic drug (OAD) for at least 12 weeks
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Treatment Details
Interventions
- Insulin Degludec (Insulin)
- Insulin Glargine (Insulin)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: IGlar followed by IDegExperimental Treatment2 Interventions
Group II: IDeg followed by IGlarExperimental Treatment2 Interventions
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Novo Nordisk Investigational SiteMesa, AZ
Novo Nordisk Investigational SiteWorcester, MA
Novo Nordisk Investigational SiteSchertz, TX
Novo Nordisk Investigational SiteSan Ramon, CA
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+