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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570751
• Other study ID #: NN1250-3943
• Secondary ID: U1111-1123-4774
• Status: Completed
• Phase: Phase 3
• First received: April 2, 2012
• Last updated: January 26, 2016
• Start date: April 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
Puerto Rico	Novo Nordisk Clinical Trial Call Center	Manati
United States	Novo Nordisk Clinical Trial Call Center	Bradenton	Florida
United States	Novo Nordisk Clinical Trial Call Center	Chattanooga	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Franklin	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Fresno	California
United States	Novo Nordisk Clinical Trial Call Center	Greenbrae	California
United States	Novo Nordisk Clinical Trial Call Center	Greenville	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Hialeah	Florida
United States	Novo Nordisk Clinical Trial Call Center	Homestead	Florida
United States	Novo Nordisk Clinical Trial Call Center	Jacksonville	Florida
United States	Novo Nordisk Clinical Trial Call Center	Jefferson City	Missouri
United States	Novo Nordisk Clinical Trial Call Center	Kettering	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Kissimmee	Florida
United States	Novo Nordisk Clinical Trial Call Center	Las Vegas	Nevada
United States	Novo Nordisk Clinical Trial Call Center	Lawrenceville	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Lexington	Kentucky
United States	Novo Nordisk Clinical Trial Call Center	Mesa	Arizona
United States	Novo Nordisk Clinical Trial Call Center	Metairie	Louisiana
United States	Novo Nordisk Clinical Trial Call Center	Miami	Florida
United States	Novo Nordisk Clinical Trial Call Center	Miami	Florida
United States	Novo Nordisk Clinical Trial Call Center	Miami Lakes	Florida
United States	Novo Nordisk Clinical Trial Call Center	Nashville	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Northport	New York
United States	Novo Nordisk Clinical Trial Call Center	Philadelphia	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Rockville	Maryland
United States	Novo Nordisk Clinical Trial Call Center	Roswell	Georgia
United States	Novo Nordisk Clinical Trial Call Center	San Antonio	Texas
United States	Novo Nordisk Clinical Trial Call Center	San Ramon	California
United States	Novo Nordisk Clinical Trial Call Center	Schertz	Texas
United States	Novo Nordisk Clinical Trial Call Center	Southfield	Michigan
United States	Novo Nordisk Clinical Trial Call Center	St. Petersburg	Florida
United States	Novo Nordisk Clinical Trial Call Center	Staten Island	New York
United States	Novo Nordisk Clinical Trial Call Center	Sugar Land	Texas
United States	Novo Nordisk Clinical Trial Call Center	Tacoma	Washington
United States	Novo Nordisk Clinical Trial Call Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period	Values for change in HbA1c after each 16 weeks of treatment periods A and B.	Week 0, week 16 of each treatment period.	No
Secondary	Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week 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.	Week 0, week 16 of each treatment period.	No
Secondary	Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B	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.	Week 16, week 20	No
Secondary	Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period	Values of FPG in mmol/L from baseline to each 16 weeks of treatment periods.	Week 0, week 16, week 32	No
Secondary	Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B	Values of FPG in mmol/L from the end of treatment period A until after 4 weeks of treatment in treatment period B.	Week 16, week 20	No
Secondary	Number of Adverse Events (AEs)	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.	From baseline to the end of each 16 week treatment period.	No

External Links

•   Clinical Trials at Novo Nordisk