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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: February 9, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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 ]
    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 ]
    Change from baseline in FPG after 26 weeks of treatment

  • Number of Treatment Emergent Hypoglycaemic Episodes [ Time Frame: During Weeks 0-26 ]
    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 ]

    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 ]
    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 ]
    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)
Sexes Eligible for Study:   All
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 Investigational Site
Greenbrae, California, United States, 94904
Novo Nordisk Investigational Site
Mission Hills, California, United States, 91345
Novo Nordisk Investigational Site
San Diego, California, United States, 92111
United States, Florida
Novo Nordisk Investigational Site
Kissimmee, Florida, United States, 34741
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60607
United States, Indiana
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46254
United States, Louisiana
Novo Nordisk Investigational Site
Slidell, Louisiana, United States, 70461-4231
United States, Maryland
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Michigan
Novo Nordisk Investigational Site
Buckley, Michigan, United States, 49620
United States, New Jersey
Novo Nordisk Investigational Site
Hillsborough, New Jersey, United States, 08844-1225
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, United States, 08648
Novo Nordisk Investigational Site
Toms River, New Jersey, United States, 08755-8050
United States, North Carolina
Novo Nordisk Investigational Site
Greensboro, North Carolina, United States, 27408
Novo Nordisk Investigational Site
Whiteville, North Carolina, United States, 28472
United States, Ohio
Novo Nordisk Investigational Site
Kettering, Ohio, United States, 45429
Novo Nordisk Investigational Site
Wadsworth, Ohio, United States, 44281-9236
United States, Pennsylvania
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
United States, Tennessee
Novo Nordisk Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Investigational Site
Austin, Texas, United States, 78731
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75230
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75246
Novo Nordisk Investigational Site
Houston, Texas, United States, 77024
Novo Nordisk Investigational Site
Round Rock, Texas, United States, 78681
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78224
United States, Washington
Novo Nordisk Investigational Site
Tacoma, Washington, United States, 98405
United States, West Virginia
Novo Nordisk Investigational Site
Martinsburg, West Virginia, United States, 25401
Algeria
Novo Nordisk Investigational Site
Algiers, Algeria
Novo Nordisk Investigational Site
Annaba, Algeria
Novo Nordisk Investigational Site
Constantine, Algeria, 25000
Novo Nordisk Investigational Site
Oran, Algeria, 31000
Austria
Novo Nordisk Investigational Site
Graz, Austria, 8036
Novo Nordisk Investigational Site
Innsbruck, Austria, 6020
Novo Nordisk Investigational Site
Linz, Austria, 4021
Novo Nordisk Investigational Site
Mödling, Austria, 2340
Novo Nordisk Investigational Site
Salzburg, Austria, 5010
Novo Nordisk Investigational Site
Wien, Austria, 1090
Novo Nordisk Investigational Site
Wien, Austria, 1130
France
Novo Nordisk Investigational Site
Caen, France, 14033
Novo Nordisk Investigational Site
LA ROCHE-sur-YON cedex 9, France, 85295
Novo Nordisk Investigational Site
LA ROCHELLE cedex, France, 17019
Novo Nordisk Investigational Site
Le Creusot, France, 71200
Novo Nordisk Investigational Site
Montpellier, France, 34000
Novo Nordisk Investigational Site
Montpellier, France, 34070
Novo Nordisk Investigational Site
Saint Herblain, France, 44800
Novo Nordisk Investigational Site
Venissieux, France, 69200
Norway
Novo Nordisk Investigational Site
Hamar, Norway, 2317
Novo Nordisk Investigational Site
Kongsvinger, Norway, 2212
Novo Nordisk Investigational Site
Kristiansand S, Norway, 4604
Novo Nordisk Investigational Site
Oslo, Norway, 0586
Novo Nordisk Investigational Site
Skedsmokorset, Norway, NO-2020
Novo Nordisk Investigational Site
Stavanger, Norway, 4011
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01713530     History of Changes
Other Study ID Numbers: NN5401-3996
2012-002346-20 ( EudraCT Number )
U1111-1130-7135 ( Other Identifier: WHO )
Study First Received: October 22, 2012
Results First Received: October 16, 2015
Last Updated: February 9, 2017

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, Long-Acting
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 27, 2017