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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01570751
First received: April 2, 2012
Last updated: January 24, 2014
Last verified: January 2014

April 2, 2012
January 24, 2014
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, week 32 ] [ Designated as safety issue: No ]
Same as current
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, week 32 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
Same as current
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
184
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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01570751
NN1250-3943, U1111-1123-4774
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Else Munksgaard Novo Nordisk A/S
Novo Nordisk A/S
January 2014

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