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

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin degludec; Drug: insulin glargine

• Registration Number: NCT01570751
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-02
• Study First Posted: 2012-04-04
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Disposition First Submitted: 2014-01-24
• Disposition First Submitted QC: 2014-01-24
• Disposition First Posted: 2014-02-24
• Results First Submitted: 2015-10-16
• Results First Submitted QC: 2015-10-16
• Results First Posted: 2015-11-18
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IDeg followed by IGlar	insulin glargine	-
IDeg followed by IGlar	insulin degludec	-
IGlar followed by IDeg	insulin degludec	-
IGlar followed by IDeg	insulin glargine	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period	Week 0, week 16 of each treatment period.	Values for change in HbA1c after each 16 weeks of treatment periods A and B.

Secondary Outcome Measures

Name	Time	Method
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.	Changes in subjects quality of life and insulin device satisfaction were evaluated using the following PROs: the Short-Form 36 Health Survey version 2 (SF-36) and the Treatment Related Impact Measure-Diabetes Device (TRIM-DD). PRO total scores were measured from baseline to the end of each 16-week treatment period. Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.
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	SF-36 and TRIM-DD total scores were measured at the end of treatment A (week 16) and 4 weeks into treatment B (week 20). Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.
Number of Adverse Events (AEs)	From baseline to the end of each 16 week treatment period.	Number of treatment emergent adverse events (TEAEs) from week 0 to week 16 of the randomised treatment periods. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. TEAEs were attributed to the treatment given in the period in which the event occurred.
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	Values of FPG in mmol/L from baseline to each 16 weeks of treatment periods.
Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B	Week 16, week 20	Values of FPG in mmol/L from the end of treatment period A until after 4 weeks of treatment in treatment period B.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇵🇷 Manati, Puerto Rico