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

Last updated: January 21, 2016
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetic Vitreous Hemorrhage

Diabetic Macular Edema

Diabetic Neuropathy

Treatment

N/A

Clinical Study ID

NCT01569841
NN1250-3874
U1111-1125-7495
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 totaldaily dose below 120 U

  • BMI (body mass index) below 35 kg/m^2

Exclusion

Exclusion Criteria:

  • Use within the last 3 months prior to visit 1 (screening) of any antidiabetic glucoselowering drug other than insulin/insulin analogues

  • Subjects with regular use of acetaminophen who are not willing to use anotheranalgetic during CGM (Continuous Glucose Monitoring) periods

  • Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronaryarterial 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 ketoacidosisduring the previous 6 months

Study Design

Total Participants: 24
Study Start date:
April 01, 2012
Estimated Completion Date:
November 30, 2012

Connect with a study center

  • Novo Nordisk Clinical Trial Call Center

    Minneapolis, Minnesota 55416-2699
    United States

    Site Not Available

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