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

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01570751

Run by

Novo Nordisk A/S

People needed

145

Starts

2012-04-01

Expected to finish

2014-01-01

Last updated by the study team

2017-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Glycosylated haemoglobin (HbA1c) equal to or above 7.5%

You may not qualify if…

• Current treatment with insulin other than insulin glargine in vials
• Treatment with thiazolidinediones or glucagon-like peptide-1 (GLP-1) receptor agonists within 12 weeks
• Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty
• Suffer from cancer (except basal cell skin cancer and squamous-cell cancer)

Where it is running

• Novo Nordisk Investigational Site — Mesa, Arizona, United States
• Novo Nordisk Investigational Site — Fresno, California, United States
• Novo Nordisk Investigational Site — Greenbrae, California, United States
• Novo Nordisk Investigational Site — San Ramon, California, United States
• Novo Nordisk Investigational Site — Bradenton, Florida, United States
• Novo Nordisk Investigational Site — Hialeah, Florida, United States
• Novo Nordisk Investigational Site — Homestead, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Kissimmee, Florida, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Miami Lakes, Florida, United States
• Novo Nordisk Investigational Site — St. Petersburg, Florida, United States
• Novo Nordisk Investigational Site — Roswell, Georgia, United States
• Novo Nordisk Investigational Site — Avon, Illinois, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Lexington, Kentucky, United States
• Novo Nordisk Investigational Site — Madisonville, Kentucky, United States
• Novo Nordisk Investigational Site — Metairie, Louisiana, United States
• Novo Nordisk Investigational Site — Slidell, Louisiana, United States
• Novo Nordisk Investigational Site — Rockville, Maryland, United States
• Novo Nordisk Investigational Site — Worcester, Massachusetts, United States
• Novo Nordisk Investigational Site — Southfield, Michigan, United States
• Novo Nordisk Investigational Site — Jefferson City, Missouri, United States
• Novo Nordisk Investigational Site — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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