A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes (SWITCH 2)

April 30, 2019 updated by: Novo Nordisk A/S

A Randomised, Double Blind, Cross-over Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes (SWITCH 2)

This trial is conducted in the United States of America (USA). The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar) with or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides in subjects with type 2 diabetes.

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.
721

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

  • Puerto Rico
      • Carolina, Puerto Rico, 00983
        • Novo Nordisk Investigational Site
      • Manati, Puerto Rico, 00674
        • Novo Nordisk Investigational Site
      • Ponce, Puerto Rico, 00717
        • Novo Nordisk Investigational Site
      • San Juan, Puerto Rico, 00921
        • Novo Nordisk Investigational Site
      • San Juan, Puerto Rico, 00918
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Novo Nordisk Investigational Site
      • Birmingham, Alabama, United States, 35215-7502
        • Novo Nordisk Investigational Site
      • Haleyville, Alabama, United States, 35565-1719
        • Novo Nordisk Investigational Site
      • Montgomery, Alabama, United States, 36106
        • Novo Nordisk Investigational Site
      • Tuscumbia, Alabama, United States, 35674
        • Novo Nordisk Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Novo Nordisk Investigational Site
      • Phoenix, Arizona, United States, 85050
        • Novo Nordisk Investigational Site
      • Tucson, Arizona, United States, 85704
        • Novo Nordisk Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Novo Nordisk Investigational Site
    • California
      • Costa Mesa, California, United States, 92626
        • Novo Nordisk Investigational Site
      • Downey, California, United States, 90242
        • Novo Nordisk Investigational Site
      • El Cajon, California, United States, 92020
        • Novo Nordisk Investigational Site
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
      • Fresno, California, United States, 93702
        • Novo Nordisk Investigational Site
      • Hawaiian Gardens, California, United States, 90716
        • Novo Nordisk Investigational Site
      • Huntington Park, California, United States, 90255
        • Novo Nordisk Investigational Site
      • Lincoln, California, United States, 95648
        • Novo Nordisk Investigational Site
      • Long Beach, California, United States, 90807
        • Novo Nordisk Investigational Site
      • Montclair, California, United States, 91763
        • Novo Nordisk Investigational Site
      • North Hollywood, California, United States, 91606
        • Novo Nordisk Investigational Site
      • Northridge, California, United States, 91325
        • Novo Nordisk Investigational Site
      • Pomona, California, United States, 91766-2007
        • Novo Nordisk Investigational Site
      • Poway, California, United States, 92064
        • Novo Nordisk Investigational Site
      • Rancho Cucamonga, California, United States, 91730-3063
        • Novo Nordisk Investigational Site
      • Rialto, California, United States, 92376
        • Novo Nordisk Investigational Site
      • Roseville, California, United States, 95661
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92111
        • Novo Nordisk Investigational Site
      • Santa Monica, California, United States, 90404
        • Novo Nordisk Investigational Site
      • Tarzana, California, United States, 91356-3551
        • Novo Nordisk Investigational Site
      • Torrance, California, United States, 90502
        • Novo Nordisk Investigational Site
      • Tustin, California, United States, 92780
        • Novo Nordisk Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Novo Nordisk Investigational Site
      • Golden, Colorado, United States, 80401
        • Novo Nordisk Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Novo Nordisk Investigational Site
    • Florida
      • Bradenton, Florida, United States, 34201
        • Novo Nordisk Investigational Site
      • Chiefland, Florida, United States, 32626
        • Novo Nordisk Investigational Site
      • Clearwater, Florida, United States, 33765
        • Novo Nordisk Investigational Site
      • Clearwater, Florida, United States, 33756
        • Novo Nordisk Investigational Site
      • Cooper City, Florida, United States, 33024
        • Novo Nordisk Investigational Site
      • Doral, Florida, United States, 33166
        • Novo Nordisk Investigational Site
      • Hialeah, Florida, United States, 33012
        • Novo Nordisk Investigational Site
      • Hialeah, Florida, United States, 33013
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32204
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32256
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32277
        • 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, 33175
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33130
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33155
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33165
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33186
        • Novo Nordisk Investigational Site
      • Miami Springs, Florida, United States, 33166
        • Novo Nordisk Investigational Site
      • Miramar, Florida, United States, 33027
        • Novo Nordisk Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Novo Nordisk Investigational Site
      • Ocala, Florida, United States, 34470
        • Novo Nordisk Investigational Site
      • Orlando, Florida, United States, 32801
        • Novo Nordisk Investigational Site
      • Panama City, Florida, United States, 32401
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33026
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33607
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33619
        • Novo Nordisk Investigational Site
    • Georgia
      • Perry, Georgia, United States, 31069
        • Novo Nordisk Investigational Site
    • Illinois
      • Champaign, Illinois, United States, 61821
        • Novo Nordisk Investigational Site
      • Chicago, Illinois, United States, 60611
        • Novo Nordisk Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Novo Nordisk Investigational Site
      • Muncie, Indiana, United States, 47304
        • Novo Nordisk Investigational Site
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Novo Nordisk Investigational Site
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Novo Nordisk Investigational Site
      • Newton, Kansas, United States, 67114
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
      • Lexington, Kentucky, United States, 40502
        • Novo Nordisk Investigational Site
      • Louisville, Kentucky, United States, 40213
        • Novo Nordisk Investigational Site
      • Paducah, Kentucky, United States, 42003
        • Novo Nordisk Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Novo Nordisk Investigational Site
      • Shreveport, Louisiana, United States, 71105
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Novo Nordisk Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Novo Nordisk Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654-3573
        • Novo Nordisk Investigational Site
    • Missouri
      • Florissant, Missouri, United States, 63031
        • Novo Nordisk Investigational Site
      • Jefferson City, Missouri, United States, 65109
        • Novo Nordisk Investigational Site
      • Kansas City, Missouri, United States, 64106
        • 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
    • New Hampshire
      • Newington, New Hampshire, United States, 03801
        • Novo Nordisk Investigational Site
    • New Jersey
      • Morganville, New Jersey, United States, 07751
        • Novo Nordisk Investigational Site
      • Teaneck, New Jersey, United States, 07666
        • Novo Nordisk Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Novo Nordisk Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • Novo Nordisk Investigational Site
      • Jackson Heights, New York, United States, 11372
        • Novo Nordisk Investigational Site
      • New Windsor, New York, United States, 12553
        • Novo Nordisk Investigational Site
      • Northport, New York, United States, 11768
        • Novo Nordisk Investigational Site
      • Smithtown, New York, United States, 11787
        • Novo Nordisk Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Novo Nordisk Investigational Site
      • Morganton, North Carolina, United States, 28655
        • Novo Nordisk Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Novo Nordisk Investigational Site
    • Ohio
      • Delaware, Ohio, United States, 43015
        • Novo Nordisk Investigational Site
      • Franklin, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
      • Toledo, Ohio, United States, 43614
        • Novo Nordisk Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Novo Nordisk Investigational Site
      • Beaver, Pennsylvania, United States, 15009
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19114
        • Novo Nordisk Investigational Site
      • Scottdale, Pennsylvania, United States, 15683
        • Novo Nordisk Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Novo Nordisk Investigational Site
      • Gaffney, South Carolina, United States, 29341
        • Novo Nordisk Investigational Site
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
      • Pelzer, South Carolina, United States, 29669
        • Novo Nordisk Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • Novo Nordisk Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Novo Nordisk Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620-7352
        • Novo Nordisk Investigational Site
      • Bristol, Tennessee, United States, 37620
        • Novo Nordisk Investigational Site
      • Chattanooga, Tennessee, United States, 37404
        • Novo Nordisk Investigational Site
      • Humboldt, Tennessee, United States, 38343
        • Novo Nordisk Investigational Site
      • Jackson, Tennessee, United States, 38305
        • Novo Nordisk Investigational Site
      • Johnson City, Tennessee, United States, 37604
        • Novo Nordisk Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk Investigational Site
    • Texas
      • Arlington, Texas, United States, 76012-4637
        • Novo Nordisk Investigational Site
      • Arlington, Texas, United States, 76012
        • Novo Nordisk Investigational Site
      • Austin, Texas, United States, 78758
        • Novo Nordisk Investigational Site
      • Carrollton, Texas, United States, 75007
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75208
        • Novo Nordisk Investigational Site
      • El Paso, Texas, United States, 79912
        • Novo Nordisk Investigational Site
      • Fort Worth, Texas, United States, 76104
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77040
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77072
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77070
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77043
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77060
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77077
        • Novo Nordisk Investigational Site
      • Humble, Texas, United States, 77338
        • Novo Nordisk Investigational Site
      • Hurst, Texas, United States, 76054
        • Novo Nordisk Investigational Site
      • Marshall, Texas, United States, 75670
        • Novo Nordisk Investigational Site
      • Mesquite, Texas, United States, 75149
        • Novo Nordisk Investigational Site
      • North Richland Hills, Texas, United States, 76180
        • Novo Nordisk Investigational Site
      • Plano, Texas, United States, 75075
        • Novo Nordisk Investigational Site
      • Plano, Texas, United States, 75093
        • Novo Nordisk Investigational Site
      • Richardson, Texas, United States, 75080
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78215
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78224
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78240
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78258
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78228-3419
        • Novo Nordisk Investigational Site
      • Sealy, Texas, United States, 77474
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Novo Nordisk Investigational Site
      • Sugar Land, Texas, United States, 77479
        • Novo Nordisk Investigational Site
      • Victoria, Texas, United States, 77901
        • Novo Nordisk Investigational Site
      • Waco, Texas, United States, 76710
        • Novo Nordisk Investigational Site
    • Utah
      • Draper, Utah, United States, 84020
        • Novo Nordisk Investigational Site
      • Ogden, Utah, United States, 84405
        • Novo Nordisk Investigational Site
      • Salt Lake City, Utah, United States, 84107
        • Novo Nordisk Investigational Site
    • Virginia
      • Chesapeake, Virginia, United States, 23321
        • Novo Nordisk Investigational Site
      • Norfolk, Virginia, United States, 23510
        • Novo Nordisk Investigational Site
    • Washington
      • Olympia, Washington, United States, 98502
        • Novo Nordisk Investigational Site
      • Renton, Washington, United States, 98057
        • Novo Nordisk Investigational Site
      • Richland, Washington, United States, 99352
        • Novo Nordisk Investigational Site
      • Spokane, Washington, United States, 99202-1334
        • Novo Nordisk Investigational Site
    • West Virginia
      • Martinsburg, West Virginia, United States, 25401
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144
        • 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: - Male or female, age at least 18 years at the time of signing informed consent - Subjects fulfilling at least one of the below criteria: a) Experienced at least one severe hypoglycaemic episode within last year (according to the ADA (American Diabetes Association) definition, April 2013), b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-Epi (Chronic Kidney Disease Epidemiology Collaboration) by central laboratory analysis, c) Hypoglycaemic symptom unawareness, d) Exposed to insulin for more than 5 years, e) Recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dL [below or equal to 3.9 mmol/L])) within the last 12 weeks prior to Visit 1 (screening) - Type 2 diabetes mellitus (diagnosed clinically) for at least 26 weeks prior to Visit 1 - Current treatment with any basal insulin (OD or BID) ± any combination of OADs (metformin, DPP-4 inhibitor, alpha-glucosidase inhibitor, thiazolidinediones, and SGLT2-inhibitor) for 26 weeks or longer prior to Visit 1 For subjects on BID the total daily dose should be below 75 units - HbA1c (glycosylated haemoglobin) below or equal to 9.5 % by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m^2 Exclusion Criteria: - Treatment with a bolus insulin separately or contained in an insulin mix product within the last 26 weeks prior to Visit 1 - Use of any other anti-diabetic agent(s) than those stated in the inclusion criteria within the last 26 weeks prior to Visit 1

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: Crossover Assignment
  • 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: IDeg OD ± OADs followed by IGlar OD ± OADs
The trial includes two 32-week treatment periods in a cross-over design. Total trial duration for the individual subjects will be up to 67 weeks.
Drug: insulin degludec
Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.
Drug: insulin glargine
Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.
Active Comparator: IGlar OD ± OADs followed by IDeg OD ± OADs
The trial includes two 32-week treatment periods in a cross-over design. Total trial duration for the individual subjects will be up to 67 weeks.
Drug: insulin degludec
Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.
Drug: insulin glargine
Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

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
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period
Time Frame: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)

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
Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period
Time Frame: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
Percentage of subjects who experienced one or more severe hypoglycaemic episodes during the maintenance period. Severe hypoglycaemia (according to the American Diabetes Association 2013 definition): A hypoglycaemic episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose values may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.
After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
Incidence of Treatment Emergent Adverse Events
Time Frame: During 32 weeks of treatment for each treatment period
Treatment emergent adverse event was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
During 32 weeks of treatment for each treatment period
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episode During the Maintenance Period
Time Frame: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.
After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Time Frame: Week 32, Week 64
Change from baseline in HbA1c (glycosylated haemoglobin) at week 32 (treatment period 1) and at week 64 (treatment period 2). Week 32 HbA1c value was considered as baseline for calculating change from baseline in HbA1c at week 64.
Week 32, Week 64
FPG (Fasting Plasma Glucose)
Time Frame: week 32, week 64
Fasting plasma glucose values at week 32 and week 64.
week 32, week 64

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.
January 6, 2014

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.
December 4, 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.
December 4, 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).
January 7, 2014

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.
January 7, 2014

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.
January 8, 2014

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.
May 10, 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.
April 30, 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.
April 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.
  • NN1250-3998
  • U1111-1143-7963 (Other Identifier: 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings