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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01570751
First received: April 2, 2012
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

This trial is conducted in the United States of America (USA). The aim of this 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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: insulin degludec
Drug: insulin glargine
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 144
Study Start Date: April 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg followed by IGlar 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: IGlar followed by IDeg 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570751

  Show 49 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Else Munksgaard Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01570751     History of Changes
Other Study ID Numbers: NN1250-3943, U1111-1123-4774
Study First Received: April 2, 2012
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013