Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes (BOOST™)

October 26, 2016 updated by: Novo Nordisk A/S

NN5401-3590: A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™ : START 1) / NN5401-3726: An Extension Trial Comparing Safety and Efficacy of NN5401 With Insulin Glargine in Subjects With Type 2 Diabetes (BOOST™: START 1)

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug).

The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

530

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

  • Austria
      • Ebreichsdorf, Austria, 2483
        • Novo Nordisk Investigational Site
      • Feldbach, Austria, 8330
        • Novo Nordisk Investigational Site
      • Innsbruck, Austria, 6020
        • Novo Nordisk Investigational Site
      • Salzburg, Austria, 5010
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1030
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1060
        • Novo Nordisk Investigational Site
  • India
      • Bangalore, India, 560038
        • Novo Nordisk Investigational Site
      • Kerala, India, 682026
        • Novo Nordisk Investigational Site
      • Patna, India, 800020
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400053
        • Novo Nordisk Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302006
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Trichy, Tamil Nadu, India, 620018
        • Novo Nordisk Investigational Site
  • Korea, Republic of
      • Pucheon, Korea, Republic of, 424-017
        • Novo Nordisk Investigational Site
      • Pusan, Korea, Republic of, 602-739
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 08308
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 137-701
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 158-710
        • Novo Nordisk Investigational Site
  • Poland
      • Krakow, Poland, 31-261
        • Novo Nordisk Investigational Site
      • Lodz, Poland, 93-338
        • Novo Nordisk Investigational Site
      • Lodz, Poland, 90-003
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-044
        • Novo Nordisk Investigational Site
      • Pruszkow, Poland, 05-800
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 02-507
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • Bayamon, Puerto Rico, 00961
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk Investigational Site
      • Nizhniy Novgorod, Russian Federation, 603126
        • Novo Nordisk Investigational Site
      • Orenburg, Russian Federation, 460040
        • Novo Nordisk Investigational Site
      • Samara, Russian Federation, 443067
        • Novo Nordisk Investigational Site
      • Saratov, Russian Federation, 410053
        • Novo Nordisk Investigational Site
      • Saratov, Russian Federation, 410710
        • Novo Nordisk Investigational Site
      • Smolensk, Russian Federation, 214019
        • Novo Nordisk Investigational Site
      • Stavropol, Russian Federation, 355017
        • Novo Nordisk Investigational Site
      • Yaroslavl, Russian Federation, 150003
        • Novo Nordisk Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29006
        • Novo Nordisk Investigational Site
      • Mérida, Spain, 06800
        • Novo Nordisk Investigational Site
      • Palma de Mallorca, Spain, 07198
        • Novo Nordisk Investigational Site
      • Partida de Bacarot, Spain, 03114
        • Novo Nordisk Investigational Site
      • Pozuelo de Alarcon, Spain, 28223
        • Novo Nordisk Investigational Site
      • San Sebastián de los Reyes, Spain, 28700
        • Novo Nordisk Investigational Site
      • Santiago de Compostela, Spain, 15706
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41009
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46014
        • Novo Nordisk Investigational Site
      • Valladolid, Spain, 47005
        • Novo Nordisk Investigational Site
  • Turkey
      • Antalya, Turkey, 07058
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34096
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34390
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34760
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34400
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Novo Nordisk Investigational Site
      • Vestavia, Alabama, United States, 35209
        • Novo Nordisk Investigational Site
    • California
      • Concord, California, United States, 94520-1926
        • Novo Nordisk Investigational Site
      • Greenbrae, California, United States, 94904
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Novo Nordisk Investigational Site
    • Florida
      • Miami, Florida, United States, 33135
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33136
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33169
        • Novo Nordisk Investigational Site
      • North Miami, Florida, United States, 33161
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33027
        • Novo Nordisk Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Novo Nordisk Investigational Site
      • Honolulu, Hawaii, United States, 96813
        • Novo Nordisk Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7596
        • Novo Nordisk Investigational Site
    • Iowa
      • Council Bluffs, Iowa, United States, 51501
        • Novo Nordisk Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006-2930
        • Novo Nordisk Investigational Site
      • New Orleans, Louisiana, United States, 70119
        • Novo Nordisk Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48235
        • Novo Nordisk Investigational Site
      • Troy, Michigan, United States, 48085-5524
        • Novo Nordisk Investigational Site
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Novo Nordisk Investigational Site
      • St. Charles, Missouri, United States, 63303
        • Novo Nordisk Investigational Site
    • New York
      • Brooklyn, New York, United States, 11203
        • Novo Nordisk Investigational Site
      • Smithtown, New York, United States, 11787
        • Novo Nordisk Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Novo Nordisk Investigational Site
      • Greenville, North Carolina, United States, 27834
        • Novo Nordisk Investigational Site
      • Morehead City, North Carolina, United States, 28557
        • Novo Nordisk Investigational Site
      • Wilson, North Carolina, United States, 27893
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Novo Nordisk Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Novo Nordisk Investigational Site
      • Portland, Oregon, United States, 97220
        • Novo Nordisk Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
      • Memphis, Tennessee, United States, 38119
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75235
        • Novo Nordisk Investigational Site
      • Lubbock, Texas, United States, 79423
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78240
        • Novo Nordisk Investigational Site
      • Tomball, Texas, United States, 77375
        • Novo Nordisk Investigational Site
    • Utah
      • St. George, Utah, United States, 84790
        • Novo Nordisk Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Novo Nordisk Investigational Site
    • Washington
      • Olympia, Washington, United States, 98502
        • 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:

  • For MAIN period (NN5401-3590):
  • Diagnosis of type 2 diabetes mellitus for at least 6 months
  • Insulin naïve subjects
  • Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
  • Glycosylated haemoglobin (HbA1c) between 7.5 - 11.0% (both inclusive)
  • Body Mass Index (BMI) no higher than 40.0 kg/m^2
  • For EXTENSION period (NN5401-3726):
  • Informed consent obtained before any trial-related activities
  • Must have completed the 26-week treatment period (visit 28) in trial NN5401-3590

Exclusion Criteria:

  • For MAIN period (NN5401-3590):
  • Treatment with glucagon like peptide-1 (GLP-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
  • Cardiovascular disease diagnosed within 6 months before trial start
  • For EXTENSION period (NN5401-3726):
  • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, Monoamine oxidase (MAO) inhibitors
  • Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements

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 OD
Drug: insulin degludec/insulin aspart
Injected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted.
EXPERIMENTAL: IGlar OD
Drug: insulin glargine
Injected s.c. (under the skin) once daily. Dose was individually adjusted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Time Frame: Week 0, Week 26
Change from baseline in HbA1c after 26 weeks of treatment.
Week 0, Week 26
Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Time Frame: Week 0 to Week 53 + 7 days follow up
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Week 0 to Week 53 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Time Frame: Week 0 to Week 53 + 7 days follow up
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Week 0 to Week 53 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Time Frame: Week 0 to Week 53 + 7 days follow up
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild:no or transient symptoms, no interference with the subject's daily activities. Moderate: marked symptoms, moderate interference with the subject's daily activities. Severe: considerable interference with the subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalisation/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect
Week 0 to Week 53 + 7 days follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Time Frame: Week 0, Week 53
Change from baseline in HbA1c after 52 weeks of treatment.
Week 0, Week 53
Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
Time Frame: Week 26
Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.
Week 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

January 1, 2010

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

January 8, 2010

First Submitted That Met QC Criteria

January 8, 2010

First Posted (ESTIMATE)

January 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-3590
  • 2009-011271-78 (EUDRACT_NUMBER)
  • U1111-1111-7178 (OTHER: WHO)
  • 2009-015839-33 (EUDRACT_NUMBER)
  • U1111-1114-9237 (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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