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

Novo Nordisk A/S1 site in 1 country24 target enrollmentApril 2012

ConditionsDiabetes Diabetes Mellitus, Type 1

Interventionsinsulin degludec insulin glargine

Drugsinsulin degludec insulin glargine

Overview

Phase: Phase 3
Intervention: insulin degludec
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 24
Locations: 1
Primary Endpoint: Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

November 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Arms & Interventions

IDeg

Intervention: insulin degludec

IGlar

Intervention: insulin glargine

Outcomes

Primary Outcomes

Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)

Time Frame: CGM occured during the last 2 weeks of the 6 weeks treatment period.

Time within the glycaemic target range \[\> 70 mg/dL (3.9 mmol/L) and \< 130 mg/dL (7.2 mmol/L)\] measured by Continuous Glucose Monitoring (CGM) in the last four hours of each dosing interval during the last 2 weeks of the 6-week treatment period.

Secondary Outcomes

Glycosylated Haemoglobin (HbA1c)(At the end of each 6 week treatment period.)
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes(Hypoglycemic episodes reported within each 6 week treatment period.)
Mean Interstitial Glucose (IG) Based on 14 Days of CGM(CGM monitoring occurred during the last 2 weeks of the 6-week treatment period.)
Fasting Plasma Glucose (FPG)(At the end of each 6 week treatment period.)
Number of Treatment Emergent Adverse Events (AEs)(Within each week 6 treatment period)