Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01713530
First received: October 22, 2012
Last updated: November 17, 2015
Last verified: November 2015
  Purpose

This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change From Baseline in HbA1c (%) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
    Change from baseline in HbA1c (%) after 26 weeks of treatment


Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
    Change from baseline in FPG after 26 weeks of treatment

  • Number of Treatment Emergent Hypoglycaemic Episodes [ Time Frame: During Weeks 0-26 ] [ Designated as safety issue: No ]
    According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) <3.1 mmol/L(56 mg/dL))

  • Number of Treatment Emergent Hypoglycaemic Episodes [ Time Frame: During Weeks 0-26 ] [ Designated as safety issue: No ]

    According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes:

    Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia


  • Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
    Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.

  • Incidence of Treatment Emergent Adverse Events (TEAE) [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
    A TEAE was defined as an event that has 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


Enrollment: 274
Study Start Date: February 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDegAsp BID+/-OADs Drug: insulin degludec/insulin aspart
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.
Experimental: IDeg OD plus IAsp +/-OADs Drug: insulin degludec
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.
Drug: insulin aspart
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1)
  • Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors
  • HbA1c 7.0% - 10.0%
  • Body mass index (BMI) less than or equal to 40.0 kg/m^2

Exclusion Criteria:

  • Treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria
  • Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Chronic disorder or disease which might jeopardise safety or compliance
  • Malignant neoplasms
  • Recurrent severe hypoglycaemia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713530

  Hide Study Locations
Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Greenbrae, California, United States, 94904
Novo Nordisk Clinical Trial Call Center
Mission Hills, California, United States, 91345
Novo Nordisk Clinical Trial Call Center
San Diego, California, United States, 92111
United States, Florida
Novo Nordisk Clinical Trial Call Center
Kissimmee, Florida, United States, 34741
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60607
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Indianapolis, Indiana, United States, 46254
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
Slidell, Louisiana, United States, 70461-4231
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Rockville, Maryland, United States, 20852
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Buckley, Michigan, United States, 49620
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Hillsborough, New Jersey, United States, 08844-1225
Novo Nordisk Clinical Trial Call Center
Lawrenceville, New Jersey, United States, 08648
Novo Nordisk Clinical Trial Call Center
Toms River, New Jersey, United States, 08755-8050
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Greensboro, North Carolina, United States, 27408
Novo Nordisk Clinical Trial Call Center
Whiteville, North Carolina, United States, 28472
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Kettering, Ohio, United States, 45429
Novo Nordisk Clinical Trial Call Center
Wadsworth, Ohio, United States, 44281-9236
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Pittsburgh, Pennsylvania, United States, 15236
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Clinical Trial Call Center
Austin, Texas, United States, 78731
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75246
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77024
Novo Nordisk Clinical Trial Call Center
Round Rock, Texas, United States, 78681
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78224
United States, Washington
Novo Nordisk Clinical Trial Call Center
Tacoma, Washington, United States, 98405
United States, West Virginia
Novo Nordisk Clinical Trial Call Center
Martinsburg, West Virginia, United States, 25401
Algeria
Algiers, Algeria
Austria
Wien, Austria, 1130
France
Le Creusot, France, 71200
Norway
Kongsvinger, Norway, 2212
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01713530     History of Changes
Other Study ID Numbers: NN5401-3996  2012-002346-20  U1111-1130-7135 
Study First Received: October 22, 2012
Results First Received: October 16, 2015
Last Updated: November 17, 2015
Health Authority: Algeria: Ministry of Health
Austria: Agency for Health and Food Safety
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Norway: Norwegian Medicines Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016