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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01570751
First Posted: April 4, 2012
Last Update Posted: March 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
April 2, 2012
April 4, 2012
October 16, 2015
November 18, 2015
March 7, 2017
April 2012
January 2014   (Final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT01570751 on ClinicalTrials.gov Archive Site
  • 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.
  • 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) ]
Not Provided
Not Provided
 
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
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 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • 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.
  • Experimental: IDeg followed by IGlar
    Interventions:
    • Drug: insulin degludec
    • Drug: insulin glargine
  • Experimental: IGlar followed by IDeg
    Interventions:
    • Drug: insulin degludec
    • Drug: insulin glargine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
January 2014
January 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT01570751
NN1250-3943
U1111-1123-4774 ( Other Identifier: WHO )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

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