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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01570751

First received: April 2, 2012

Last updated: January 18, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 2, 2012

Last Updated Date

January 18, 2013

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline (visit 18) in glycosylated haemoglobin (HbA1c) at the end of each 16 week treatment period [ Time Frame: Week 0, week 16, week 32 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01570751 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in patient reported outcome (PRO) scores from baseline to the end of each 16 week treatment period [ Time Frame: Week 0, week 16, week 32 ] [ Designated as safety issue: No ]
Change in PRO scores from the end of treatment period A until after 4 weeks of treatment in treatment period B [ Time Frame: Week 16, week 20 ] [ Designated as safety issue: No ]
Change from baseline in central laboratory measured fasting plasma glucose (FPG) at the end of each 16 week treatment period [ Time Frame: Week 0, week 16, week 32 ] [ Designated as safety issue: No ]
Change in FPG from the end of treatment period A until after 4 weeks of treatment in treatment period B [ Time Frame: Week 16, week 20 ] [ Designated as safety issue: No ]
Number of adverse events (AEs) [ Time Frame: From the start of the run-in period (week -16 (visit 2)) to the follow-up visit (week 33) ] [ 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, 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

Official Title ^ICMJE

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

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: insulin degludec
Cross-over trial, part 1: Individually adjusted IDeg administered subcutaneously (s.c., under the skin) once daily for 16 weeks in each treatment period.
Drug: insulin glargine
Cross-over trial, part 2: Individually adjusted IGlar administered subcutaneously (s.c., under the skin) once daily for the 16 week run-in period followed by 16 weeks in each treatment period.

Study Arm (s)

Experimental: IDeg followed by IGlar
Interventions:
- Drug: insulin degludec
- Drug: insulin glargine
Experimental: IGlar followed by IDeg
Interventions:
- Drug: insulin degludec
- 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

Active, not recruiting

Estimated Enrollment ^ICMJE

144

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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%

Exclusion Criteria:

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)

Gender

Both

Ages

18 Years and older

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

NCT01570751

Other Study ID Numbers ^ICMJE

NN1250-3943, U1111-1123-4774

Has Data Monitoring Committee

Responsible Party

Novo Nordisk

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Else Munksgaard

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

January 2013

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

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