Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes (onset® 1)

May 28, 2019 updated by: Novo Nordisk A/S
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes. This trial consists of two periods: a 26 week treatment period followed by a 26 week additional treatment period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1290

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Belgium
      • Bonheiden, Belgium, 2820
        • Novo Nordisk Investigational Site
      • Brussels, Belgium, 1070
        • Novo Nordisk Investigational Site
      • Edegem, Belgium, 2650
        • Novo Nordisk Investigational Site
      • Gent, Belgium, 9000
        • Novo Nordisk Investigational Site
      • Leuven, Belgium, 3000
        • Novo Nordisk Investigational Site
  • Canada
      • Quebec, Canada, G1V 4G2
        • Novo Nordisk Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2E1
        • Novo Nordisk Investigational Site
      • Edmonton, Alberta, Canada, T5J 3N4
        • Novo Nordisk Investigational Site
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 1J8
        • Novo Nordisk Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Novo Nordisk Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Novo Nordisk Investigational Site
      • London, Ontario, Canada, N6G 2M1
        • Novo Nordisk Investigational Site
      • London, Ontario, Canada, N6A 4V2
        • Novo Nordisk Investigational Site
      • Mississauga, Ontario, Canada, L5M 2V8
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M5T 3L9
        • Novo Nordisk Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2W 1R7
        • Novo Nordisk Investigational Site
      • Sherbrooke, Quebec, Canada, J1G 5K2
        • Novo Nordisk Investigational Site
  • Czechia
      • Brno, Czechia, 65691
        • Novo Nordisk Investigational Site
      • Hradec Kralove, Czechia, 50005
        • Novo Nordisk Investigational Site
      • Prague 4, Czechia, 140 21
        • Novo Nordisk Investigational Site
      • Praha, Czechia, 12808
        • Novo Nordisk Investigational Site
      • Praha 10, Czechia, 100 00
        • Novo Nordisk Investigational Site
  • Finland
      • Helsinki, Finland, 00260
        • Novo Nordisk Investigational Site
      • Kerava, Finland, FI-04200
        • Novo Nordisk Investigational Site
      • Lappeenranta, Finland, 53130
        • Novo Nordisk Investigational Site
      • Raisio, Finland, 21200
        • Novo Nordisk Investigational Site
      • Tampere, Finland, 33900
        • Novo Nordisk Investigational Site
      • Turku, Finland, FI-20100
        • Novo Nordisk Investigational Site
  • Germany
      • Bad Mergentheim, Germany, 97980
        • Novo Nordisk Investigational Site
      • Berlin, Germany, 13597
        • Novo Nordisk Investigational Site
      • Damme, Germany, 49401
        • Novo Nordisk Investigational Site
      • Dresden, Germany, 01219
        • Novo Nordisk Investigational Site
      • Dresden, Germany, 01307
        • Novo Nordisk Investigational Site
      • Elsterwerda, Germany, 04910
        • Novo Nordisk Investigational Site
      • Falkensee, Germany, 14612
        • Novo Nordisk Investigational Site
      • Friedrichsthal, Germany, 66299
        • Novo Nordisk Investigational Site
      • Fulda, Germany, 36037
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 22607
        • Novo Nordisk Investigational Site
      • Hohenmölsen, Germany, 06679
        • Novo Nordisk Investigational Site
      • Lingen, Germany, 49808
        • Novo Nordisk Investigational Site
      • Ludwigshafen, Germany, 67059
        • Novo Nordisk Investigational Site
      • Münster, Germany, 48145
        • Novo Nordisk Investigational Site
      • Münster, Germany, 48143
        • Novo Nordisk Investigational Site
      • Neuwied, Germany, 56564
        • Novo Nordisk Investigational Site
      • Oldenburg, Germany, 23758
        • Novo Nordisk Investigational Site
      • Rehburg-Loccum, Germany, 31547
        • Novo Nordisk Investigational Site
      • Rehlingen-Siersburg, Germany, 66780
        • Novo Nordisk Investigational Site
      • Rostock, Germany, 18057
        • Novo Nordisk Investigational Site
      • Saint Ingbert-Oberwürzbach, Germany, 66386
        • Novo Nordisk Investigational Site
      • Schweinfurt, Germany, 97421
        • Novo Nordisk Investigational Site
      • Völklingen, Germany, 66333
        • Novo Nordisk Investigational Site
      • Wangen, Germany, 88239
        • Novo Nordisk Investigational Site
      • Zwenkau, Germany, 04442
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1089
        • Novo Nordisk Investigational Site
      • Budapest, Hungary, 1076
        • Novo Nordisk Investigational Site
      • Debrecen, Hungary, 4043
        • Novo Nordisk Investigational Site
      • Kaposvár, Hungary, 7400
        • Novo Nordisk Investigational Site
      • Szeged, Hungary, H-6720
        • Novo Nordisk Investigational Site
      • Szombathely, Hungary, H-9700
        • Novo Nordisk Investigational Site
  • Poland
      • Bialystok, Poland, 15-435
        • Novo Nordisk Investigational Site
      • Gdansk, Poland, 80-858
        • Novo Nordisk Investigational Site
      • Krakow, Poland, 31-261
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-538
        • Novo Nordisk Investigational Site
      • Szczecin, Poland, 70-376
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 02-507
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Novo Nordisk Investigational Site
      • Gillingham, United Kingdom, ME7 5NY
        • Novo Nordisk Investigational Site
      • Glasgow, United Kingdom, G21 3UW
        • Novo Nordisk Investigational Site
      • Guildford, United Kingdom, GU2 7XX
        • Novo Nordisk Investigational Site
      • Inverness, United Kingdom, IV2 3UJ
        • Novo Nordisk Investigational Site
      • Inverness, United Kingdom, IV2 3JH
        • Novo Nordisk Investigational Site
      • Ipswich, United Kingdom, IP4 5PD
        • Novo Nordisk Investigational Site
      • Nottingham, United Kingdom, NG7 2UH
        • Novo Nordisk Investigational Site
      • Portsmouth, United Kingdom, PO6 3LY
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S5 7AU
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Novo Nordisk Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85714
        • Novo Nordisk Investigational Site
      • Tucson, Arizona, United States, 85724
        • Novo Nordisk Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk Investigational Site
      • Concord, California, United States, 94520
        • Novo Nordisk Investigational Site
      • Escondido, California, United States, 92025
        • Novo Nordisk Investigational Site
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
      • Fullerton, California, United States, 92835
        • Novo Nordisk Investigational Site
      • Inglewood, California, United States, 90301
        • Novo Nordisk Investigational Site
      • La Jolla, California, United States, 92037
        • Novo Nordisk Investigational Site
      • La Mesa, California, United States, 91942
        • Novo Nordisk Investigational Site
      • Long Beach, California, United States, 90807
        • Novo Nordisk Investigational Site
      • North Hollywood, California, United States, 91606
        • Novo Nordisk Investigational Site
      • Northridge, California, United States, 91324
        • Novo Nordisk Investigational Site
      • Poway, California, United States, 92064
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92037
        • Novo Nordisk Investigational Site
      • Santa Barbara, California, United States, 93105
        • Novo Nordisk Investigational Site
      • Santa Barbara, California, United States, 93105-4321
        • Novo Nordisk Investigational Site
      • Ventura, California, United States, 93003
        • Novo Nordisk Investigational Site
      • Ventura, California, United States, 93003-2824
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80209
        • Novo Nordisk Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Novo Nordisk Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33433
        • Novo Nordisk Investigational Site
      • Coral Gables, Florida, United States, 33134
        • Novo Nordisk Investigational Site
      • Fleming Island, Florida, United States, 32203
        • Novo Nordisk Investigational Site
      • Fort Lauderdale, Florida, United States, 33312
        • Novo Nordisk Investigational Site
      • Fort Lauderdale, Florida, United States, 33308
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32204
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33156
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33174
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33136
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33173
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33015
        • Novo Nordisk Investigational Site
      • Sanford, Florida, United States, 32771
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33614
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Novo Nordisk Investigational Site
      • Atlanta, Georgia, United States, 30339
        • Novo Nordisk Investigational Site
      • Dunwoody, Georgia, United States, 30338
        • Novo Nordisk Investigational Site
      • Lawrenceville, Georgia, United States, 30046
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Novo Nordisk Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7596
        • Novo Nordisk Investigational Site
      • Nampa, Idaho, United States, 83686-6011
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, United States, 60064
        • Novo Nordisk Investigational Site
      • Crystal Lake, Illinois, United States, 60012
        • Novo Nordisk Investigational Site
      • Springfield, Illinois, United States, 62711
        • Novo Nordisk Investigational Site
    • Indiana
      • Muncie, Indiana, United States, 47304
        • Novo Nordisk Investigational Site
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Novo Nordisk Investigational Site
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
      • Lexington, Kentucky, United States, 40502
        • Novo Nordisk Investigational Site
    • Maine
      • Portland, Maine, United States, 04101
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Novo Nordisk Investigational Site
      • Baltimore, Maryland, United States, 21204
        • Novo Nordisk Investigational Site
      • Hyattsville, Maryland, United States, 20782
        • Novo Nordisk Investigational Site
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Waltham, Massachusetts, United States, 02453
        • Novo Nordisk Investigational Site
      • Worcester, Massachusetts, United States, 01655
        • Novo Nordisk Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Novo Nordisk Investigational Site
    • Minnesota
      • Eagan, Minnesota, United States, 55123
        • Novo Nordisk Investigational Site
      • Minneapolis, Minnesota, United States, 55416
        • Novo Nordisk Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64106
        • Novo Nordisk Investigational Site
      • Springfield, Missouri, United States, 65807
        • Novo Nordisk Investigational Site
    • Montana
      • Butte, Montana, United States, 59701
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Novo Nordisk Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052-2649
        • Novo Nordisk Investigational Site
      • Las Vegas, Nevada, United States, 89148
        • Novo Nordisk Investigational Site
      • Las Vegas, Nevada, United States, 89128
        • Novo Nordisk Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, United States, 03063
        • Novo Nordisk Investigational Site
    • New Jersey
      • Hoboken, New Jersey, United States, 07030
        • Novo Nordisk Investigational Site
      • Jersey City, New Jersey, United States, 07306
        • Novo Nordisk Investigational Site
      • Lawrenceville, New Jersey, United States, 08648
        • Novo Nordisk Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Novo Nordisk Investigational Site
      • Albuquerque, New Mexico, United States, 87109-2134
        • Novo Nordisk Investigational Site
      • Albuquerque, New Mexico, United States, 87131
        • Novo Nordisk Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • Novo Nordisk Investigational Site
      • New York, New York, United States, 10029
        • Novo Nordisk Investigational Site
      • Rochester, New York, United States, 14607
        • Novo Nordisk Investigational Site
      • Smithtown, New York, United States, 11787
        • Novo Nordisk Investigational Site
      • Staten Island, New York, United States, 10301
        • Novo Nordisk Investigational Site
      • Staten Island, New York, United States, 10301-3901
        • Novo Nordisk Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • 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
    • Ohio
      • Columbus, Ohio, United States, 43201
        • Novo Nordisk Investigational Site
      • Mentor, Ohio, United States, 44060
        • Novo Nordisk Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Novo Nordisk Investigational Site
      • Portland, Oregon, United States, 97210
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046-3638
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19140
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19140-5103
        • Novo Nordisk Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605-4254
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Novo Nordisk Investigational Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Novo Nordisk Investigational Site
      • Austin, Texas, United States, 78731
        • Novo Nordisk Investigational Site
      • Beaumont, Texas, United States, 77701
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75390-9302
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75231
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75246
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77079
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77099
        • Novo Nordisk Investigational Site
      • Lubbock, Texas, United States, 79423
        • Novo Nordisk Investigational Site
      • Plano, Texas, United States, 75093
        • Novo Nordisk Investigational Site
      • Round Rock, Texas, United States, 78681
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77479
        • Novo Nordisk Investigational Site
    • Utah
      • Magna, Utah, United States, 84044
        • Novo Nordisk Investigational Site
    • Washington
      • Olympia, Washington, United States, 98502
        • Novo Nordisk Investigational Site
      • Renton, Washington, United States, 98057
        • Novo Nordisk Investigational Site
      • Spokane, Washington, United States, 99208
        • Novo Nordisk Investigational Site
      • Spokane, Washington, United States, 99201
        • Novo Nordisk Investigational Site
      • Spokane, Washington, United States, 99202
        • Novo Nordisk Investigational Site
      • Spokane, Washington, United States, 99202-1334
        • Novo Nordisk Investigational Site
      • Spokane, Washington, United States, 99202-3649
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: - Type 1 diabetes (diagnosed clinically) for 12 months or longer at the time of screening (Visit 1) - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index (BMI) below or equal to 35.0 kg/m^2 Exclusion Criteria: - Use of any anti-diabetic drug other than insulin within the last 3 months prior to screening (Visit 1) - Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1) - Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris, coronary arterial bypass graft or angioplasty

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: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Meal time FIAsp and insulin detemir
Drug: Faster-acting insulin aspart
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.
Drug: insulin detemir
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.
Drug: Faster-acting insulin aspart
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Post meal time dosing is defined as injecting 20 minutes after the start of the meal.
ACTIVE_COMPARATOR: Meal time insulin aspart and insulin detemir
Drug: insulin detemir
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.
Drug: insulin aspart
Injected subcutaneously (s.c., under the skin), dose individually adjusted.
EXPERIMENTAL: Post meal FIAsp and insulin detemir
Drug: Faster-acting insulin aspart
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.
Drug: insulin detemir
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.
Drug: Faster-acting insulin aspart
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Post meal time dosing is defined as injecting 20 minutes after the start of the meal.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Time Frame: Week 0, week 26
Change from baseline in HbA1c after 26 weeks of randomised treatment.
Week 0, week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test)
Time Frame: Week 0, week 26
Change from baseline in 2-hour PPG increments after 26 weeks of randomised treatment (meal test).
Week 0, week 26
Change From Baseline in HbA1c (Post Meal Arm)
Time Frame: Week 0, week 26
Change from baseline in HbA1c (post meal arm) after 26 weeks of randomised treatment.
Week 0, week 26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
Time Frame: From baseline until week 26
Observed rate of treatment emergent severe or BG confirmed hypoglycaemic events per 100 patient years of exposure (PYE) from baseline until week 26. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe or BG confirmed is an episode that is severe according to the American Diabetes Association (ADA) classification (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.
From baseline until week 26
Change From Baseline in Body Weight
Time Frame: Week 0, week 26
Change from baseline in body weight after 26 weeks of randomised treatment.
Week 0, week 26
Frequency of Adverse Events
Time Frame: After 52 weeks of randomised treatment
All treatment emergent adverse events (TEAEs) from baseline until 52 weeks of randomised treatment. A TEAE was defined as an event that had an 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.
After 52 weeks of randomised treatment
Change in HbA1c
Time Frame: Week 0, week 52
Change from baseline in HbA1c (%) after 52 weeks of randomised treatment.
Week 0, week 52
Change in PPG (Postprandial Glucose)
Time Frame: Week 0, week 52
Change from baseline in PPG and PPG increment (meal test) after 52 weeks of randomised treatment.
Week 0, week 52

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 26, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 12, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 11, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN1218-3852
  • 2010-024049-53 (EUDRACT_NUMBER)
  • U1111-1118-2442 (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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