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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01569841

First received: March 30, 2012

Last updated: December 19, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 30, 2012

Last Updated Date

December 19, 2012

Start Date ^ICMJE

April 2012

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Average time within glycaemic target range (above 70 mg/dL and below 130 mg/dL) [ Time Frame: In the last four hours of each dosing interval during 14 days of CGM (Continuous Glucose Monitoring) usage in the last 2 weeks of the 6 weeks treatment period ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01569841 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mean IG (Interstitial Glucose) based on 14 days of CGM [ Time Frame: After 6 weeks of treatment ] [ Designated as safety issue: No ]
Fasting plasma glucose (FPG) [ Time Frame: After 6 weeks of treatment ] [ Designated as safety issue: No ]
HbA1c (glycosylated haemoglobin) [ Time Frame: After 6 weeks of treatment ] [ Designated as safety issue: No ]
Number of treatment emergent AEs (adverse events) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Number of treatment emergent hypoglycaemic episodes [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 1

Intervention ^ICMJE

Drug: insulin degludec
Administered subcutaneously (s.c., under the skin) once daily.
Drug: insulin glargine
Administered subcutaneously (s.c., under the skin) once daily.

Study Arm (s)

Experimental: IDeg
Intervention: Drug: insulin degludec
Active Comparator: IGlar
Intervention: Drug: insulin glargine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2012

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01569841

Other Study ID Numbers ^ICMJE

NN1250-3874, U1111-1125-7495

Has Data Monitoring Committee

Responsible Party

Novo Nordisk

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Iben Turi Sjöberg

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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