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

Novo Nordisk A/S1 site in 1 country145 target enrollmentApril 2012

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsinsulin degludec insulin glargine

Drugsinsulin degludec insulin glargine

Overview

Phase: Phase 3
Intervention: insulin degludec
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 145
Locations: 1
Primary Endpoint: Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period
Status: Completed
Last Updated: 9 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 the 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.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

January 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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)

Arms & Interventions

IDeg followed by IGlar

Intervention: insulin degludec

IDeg followed by IGlar

Intervention: insulin glargine

IGlar followed by IDeg

Intervention: insulin degludec

IGlar followed by IDeg

Intervention: insulin glargine

Outcomes

Primary Outcomes

Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period

Time Frame: Week 0, week 16 of each treatment period.

Values for change in HbA1c after each 16 weeks of treatment periods A and B.

Secondary Outcomes

Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period(Week 0, week 16 of each treatment period.)
Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B(Week 16, week 20)
Number of Adverse Events (AEs)(From baseline to the end of each 16 week treatment period.)
Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period(Week 0, week 16, week 32)
Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B(Week 16, week 20)