A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 1

In brief

This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy of insulin decludec with insulin glargine on glycaemic control using continuous glucose monitoring in patients with type 1 diabetes.

Key facts

Study ID

NCT01569841

Run by

Novo Nordisk A/S

People needed

24

Starts

2012-04-01

Expected to finish

2012-11-01

Last updated by the study team

2016-02-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 diabetes
• HbA1c (glycosylated haemoglobin) below or equal to 8.5%
• Current treatment with IGlar (insulin glargine) in a basal-bolus regimen with a total daily dose below 120 U
• BMI (body mass index) below 35 kg/m\^2

You may not qualify if…

• Use within the last 3 months prior to visit 1 (screening) of any antidiabetic glucose lowering drug other than insulin/insulin analogues
• Subjects with regular use of acetaminophen who are not willing to use another analgetic during CGM (Continuous Glucose Monitoring) periods
• Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty within 24 weeks prior to visit 1
• Recurrent severe hypoglycemia (more than one severe hypoglycemic event during the last 12 months) or hypoglycemia unawareness or hospitalization for diabetic ketoacidosis during the previous 6 months

Where it is running

• Novo Nordisk Clinical Trial Call Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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