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

March 6, 2018 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

274

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Algiers, Algeria
        • Novo Nordisk Investigational Site
      • Annaba, Algeria
        • Novo Nordisk Investigational Site
      • Constantine, Algeria, 25000
        • Novo Nordisk Investigational Site
      • Oran, Algeria, 31000
        • Novo Nordisk Investigational Site
  • Austria
      • 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
        • Novo Nordisk Investigational Site
  • France
      • 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
        • Novo Nordisk Investigational Site
  • Norway
      • 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
        • Novo Nordisk Investigational Site
  • United States
    • California
      • 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
        • Novo Nordisk Investigational Site
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Novo Nordisk Investigational Site
    • Louisiana
      • Slidell, Louisiana, United States, 70461-4231
        • Novo Nordisk Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Novo Nordisk Investigational Site
    • New Jersey
      • 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
        • Novo Nordisk Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Novo Nordisk Investigational Site
      • Whiteville, North Carolina, United States, 28472
        • Novo Nordisk Investigational Site
    • Ohio
      • Kettering, Ohio, United States, 45429
        • Novo Nordisk Investigational Site
      • Wadsworth, Ohio, United States, 44281-9236
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15236
        • Novo Nordisk Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk Investigational Site
    • Texas
      • 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
        • Novo Nordisk Investigational Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Novo Nordisk Investigational Site
    • West Virginia
      • Martinsburg, West Virginia, United States, 25401
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c (%)
Time Frame: Week 0, week 26
Change from baseline in HbA1c (%) after 26 weeks of treatment
Week 0, week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, week 26
Change from baseline in FPG after 26 weeks of treatment
Week 0, week 26
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))
During Weeks 0-26
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
During Weeks 0-26
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.
Weeks 0-26
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
Weeks 0-26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 21, 2013

Primary Completion (ACTUAL)

January 9, 2014

Study Completion (ACTUAL)

January 9, 2014

Study Registration Dates

First Submitted

October 22, 2012

First Submitted That Met QC Criteria

October 22, 2012

First Posted (ESTIMATE)

October 24, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-3996
  • 2012-002346-20 (EUDRACT_NUMBER)
  • U1111-1130-7135 (OTHER: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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