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

Tracking Information
First Submitted Date ICMJE	April 2, 2012
First Posted Date ICMJE	April 4, 2012
Results First Submitted Date	October 16, 2015
Results First Posted Date	November 18, 2015
Last Update Posted Date	March 7, 2017
Study Start Date ICMJE	April 2012
Actual Primary Completion Date	January 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 16, 2015)	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.
Original Primary Outcome Measures ICMJE; (submitted: April 2, 2012)	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 ]
Change History	Complete list of historical versions of study NCT01570751 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 16, 2015)	Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period [ Time Frame: 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 [ Time Frame: 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.; 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 ]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 [ Time Frame: 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.; Number of Adverse Events (AEs) [ Time Frame: 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.
Original Secondary Outcome Measures ICMJE; (submitted: April 2, 2012)	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 ]; 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 ]; 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 ]; 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 ]; 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) ]
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 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 Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (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 Arms	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 *	Warren M, Chaykin L, Jabbour S, Sheikh-Ali M, Hansen CT, Rasmussen S, Norwood P. Efficacy, patient-reported outcomes (PRO) and safety of insulin degludec U200 vs insulin glargine in patients with type 2 diabetes (T2D) requiring high-dose insulin. Diabetes 2015; Suppl. 1 (64): A266 (Abstract 1040-P); Warren M., Chaykin L.B., Jabbour S.,Sheikh-Ali M., Hansen C.T., Nielsen T.S.S., Norwood P.. Efficacy, patient-reported outcomes (PRO) and safety of insulin degludec U200 vs insulin glargine in patients with type 2 diabetes (T2D) requiring high-dose insulin. Diabetologia 2015; 58 (Suppl. 1): S468: (Abstract 968); Warren ML, Chaykin LB, Jabbour S, Sheikh-Ali M, Hansen CT, Nielsen TSS, Norwood P. Insulin Degludec 200 Units/mL Is Associated With Lower Injection Frequency and Improved Patient-Reported Outcomes Compared With Insulin Glargine 100 Units/mL in Patients With Type 2 Diabetes Requiring High-Dose Insulin. Clin Diabetes. 2017 Apr;35(2):90-95. doi: 10.2337/cd15-0058.
* 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
Actual Enrollment ICMJE; (submitted: October 16, 2015)	145
Original Estimated Enrollment ICMJE; (submitted: April 2, 2012)	144
Actual Study Completion Date	January 2014
Actual 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)
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Puerto Rico, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01570751
Other Study ID Numbers ICMJE	NN1250-3943; U1111-1123-4774 ( Other Identifier: WHO )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Novo Nordisk A/S
Study Sponsor ICMJE	Novo Nordisk A/S
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account	Novo Nordisk A/S
Verification Date	January 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP