Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes (onset® 2)

January 10, 2019 updated by: Novo Nordisk A/S
This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults 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.
881

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

  • Canada
      • Quebec, Canada, G1G 3Y8
        • Novo Nordisk Investigational Site
      • Quebec, Canada, G1N 4V3
        • Novo Nordisk Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada, T5J 3N4
        • Novo Nordisk Investigational Site
    • British Columbia
      • Surrey, British Columbia, Canada, V3S 2N6
        • Novo Nordisk Investigational Site
    • Newfoundland and Labrador
      • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
        • Novo Nordisk Investigational Site
      • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
        • Novo Nordisk Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8M 1K7
        • Novo Nordisk Investigational Site
      • Thunder Bay, Ontario, Canada, P7B 7C7
        • Novo Nordisk Investigational Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • Novo Nordisk Investigational Site
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
        • Novo Nordisk Investigational Site
      • Montreal, Quebec, Canada, H1Y 3L1
        • Novo Nordisk Investigational Site
      • Montreal, Quebec, Canada, H2R 1V6
        • Novo Nordisk Investigational Site
      • St. Romuald, Quebec, Canada, G6W 5M6
        • Novo Nordisk Investigational Site
  • Croatia
      • Cakovec, Croatia, 40000
        • Novo Nordisk Investigational Site
      • Karlovac, Croatia, 47000
        • Novo Nordisk Investigational Site
      • Osijek, Croatia, 31 000
        • Novo Nordisk Investigational Site
      • Slavonski Brod, Croatia, 35 000
        • Novo Nordisk Investigational Site
      • Split, Croatia, 21 000
        • Novo Nordisk Investigational Site
      • Varazdin, Croatia, 42 000
        • Novo Nordisk Investigational Site
      • Zagreb, Croatia, 10 000
        • Novo Nordisk Investigational Site
      • Zagreb, Croatia, 10000
        • Novo Nordisk Investigational Site
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500082
        • Novo Nordisk Investigational Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 400012
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 400058
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India, 411004
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India, 411040
        • Novo Nordisk Investigational Site
    • New Delhi
      • Delhi, New Delhi, India, 110002
        • Novo Nordisk Investigational Site
    • Orissa
      • Bhubaneswar, Orissa, India, 751019
        • Novo Nordisk Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302006
        • Novo Nordisk Investigational Site
  • Israel
      • Beer Sheva, Israel, 84101
        • Novo Nordisk Investigational Site
      • Haifa, Israel, 35152
        • Novo Nordisk Investigational Site
      • Jerusalem, Israel, 91120
        • Novo Nordisk Investigational Site
      • Kfar Saba, Israel, 44281
        • Novo Nordisk Investigational Site
      • Rehovot, Israel, 76100
        • Novo Nordisk Investigational Site
      • Rishon Le Zion, Israel, 75650
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Kursk, Russian Federation, 305035
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 119435
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 127644
        • Novo Nordisk Investigational Site
      • Penza, Russian Federation, 440026
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 195257
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 194358
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 199034
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 191119
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 194291
        • Novo Nordisk Investigational Site
      • Saint-Petesburg, Russian Federation, 195257
        • Novo Nordisk Investigational Site
      • Stavropol, Russian Federation, 355035
        • Novo Nordisk Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Novo Nordisk Investigational Site
      • Nis, Serbia, 18000
        • Novo Nordisk Investigational Site
      • Zajecar, Serbia, 19000
        • Novo Nordisk Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 851 01
        • Novo Nordisk Investigational Site
      • Bratislava, Slovakia, 821 02
        • Novo Nordisk Investigational Site
      • Lucenec, Slovakia, 984 01
        • Novo Nordisk Investigational Site
      • Trnava, Slovakia, 91701
        • Novo Nordisk Investigational Site
      • Zilina, Slovakia, 01001
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Epworth, United Kingdom, DN9 1EP
        • Novo Nordisk Investigational Site
      • Hull, United Kingdom, HU3 2RW
        • Novo Nordisk Investigational Site
      • Northampton, United Kingdom, NN1 5BD
        • Novo Nordisk Investigational Site
      • Northwood, United Kingdom, HA6 2RN
        • Novo Nordisk Investigational Site
      • Norwich, United Kingdom, NR4 7TJ
        • Novo Nordisk Investigational Site
      • Nuneaton, United Kingdom, CV10 7DJ
        • Novo Nordisk Investigational Site
      • Sidcup, United Kingdom, DA14 6LT
        • Novo Nordisk Investigational Site
      • Stoke on Trent, United Kingdom, ST4 6QG
        • Novo Nordisk Investigational Site
      • Wrexham, United Kingdom, LL13 7TD
        • Novo Nordisk Investigational Site
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306-4652
        • Novo Nordisk Investigational Site
      • Glendale, Arizona, United States, 85308
        • Novo Nordisk Investigational Site
      • Mesa, Arizona, United States, 85213
        • Novo Nordisk Investigational Site
      • Phoenix, Arizona, United States, 85020
        • Novo Nordisk Investigational Site
      • Tempe, Arizona, United States, 85283
        • Novo Nordisk Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Novo Nordisk Investigational Site
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
      • Greenbrae, California, United States, 94904
        • Novo Nordisk Investigational Site
      • Lomita, California, United States, 90717
        • Novo Nordisk Investigational Site
      • Northridge, California, United States, 91325
        • Novo Nordisk Investigational Site
      • San Diego, California, United States, 92111
        • Novo Nordisk Investigational Site
      • San Ramon, California, United States, 94583
        • Novo Nordisk Investigational Site
      • Walnut Creek, California, United States, 94598
        • Novo Nordisk Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Novo Nordisk Investigational Site
      • Colorado Springs, Colorado, United States, 80910
        • Novo Nordisk Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Novo Nordisk Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Novo Nordisk Investigational Site
      • Bradenton, Florida, United States, 34201
        • Novo Nordisk Investigational Site
      • Cooper City, Florida, United States, 33024
        • Novo Nordisk Investigational Site
      • Fort Lauderdale, Florida, United States, 33316
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32205
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33144
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33173
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33027
        • Novo Nordisk Investigational Site
      • Plantation, Florida, United States, 33324
        • Novo Nordisk Investigational Site
      • Tampa, Florida, United States, 33603
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308-2253
        • Novo Nordisk Investigational Site
      • Atlanta, Georgia, United States, 30328
        • Novo Nordisk Investigational Site
      • Decatur, Georgia, United States, 30033
        • Novo Nordisk Investigational Site
      • Roswell, Georgia, United States, 30076
        • Novo Nordisk Investigational Site
    • Illinois
      • Avon, Illinois, United States, 46123
        • Novo Nordisk Investigational Site
      • Peoria, Illinois, United States, 61602
        • Novo Nordisk Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Novo Nordisk Investigational Site
      • Muncie, Indiana, United States, 47304
        • Novo Nordisk Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Novo Nordisk Investigational Site
      • Madisonville, Kentucky, United States, 42431-1661
        • Novo Nordisk Investigational Site
      • Paducah, Kentucky, United States, 42003
        • Novo Nordisk Investigational Site
    • Louisiana
      • Monroe, Louisiana, United States, 71203
        • Novo Nordisk Investigational Site
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Novo Nordisk Investigational Site
      • Detroit, Michigan, United States, 48201
        • Novo Nordisk Investigational Site
      • Troy, Michigan, United States, 48085-5524
        • Novo Nordisk Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Novo Nordisk Investigational Site
      • Jefferson City, Missouri, United States, 65109
        • Novo Nordisk Investigational Site
      • Saint Louis, Missouri, United States, 63141
        • Novo Nordisk Investigational Site
    • Montana
      • Butte, Montana, United States, 59701
        • Novo Nordisk Investigational Site
    • Nebraska
      • Elkhorn, Nebraska, United States, 68022
        • Novo Nordisk Investigational Site
      • Omaha, Nebraska, United States, 68198-3020
        • Novo Nordisk Investigational Site
      • Omaha, Nebraska, United States, 68105
        • Novo Nordisk Investigational Site
    • New Jersey
      • Toms River, New Jersey, United States, 08755-8050
        • Novo Nordisk Investigational Site
    • New York
      • Mineola, New York, United States, 11501
        • Novo Nordisk Investigational Site
      • New Windsor, New York, United States, 12553
        • Novo Nordisk Investigational Site
      • North Massapequa, New York, United States, 11758-1802
        • Novo Nordisk Investigational Site
      • Northport, New York, United States, 11768
        • Novo Nordisk Investigational Site
    • North Carolina
      • Hickory, North Carolina, United States, 28601
        • Novo Nordisk Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • Novo Nordisk Investigational Site
    • Ohio
      • Carlisle, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
      • Cleveland, Ohio, United States, 44122
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45439
        • Novo Nordisk Investigational Site
      • Franklin, Ohio, United States, 45005
        • Novo Nordisk Investigational Site
      • Mason, Ohio, United States, 45040-6815
        • Novo Nordisk Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Novo Nordisk Investigational Site
    • South Carolina
      • Gaffney, South Carolina, United States, 29341
        • Novo Nordisk Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404-1192
        • Novo Nordisk Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Novo Nordisk Investigational Site
      • Spring Hill, Tennessee, United States, 37174
        • Novo Nordisk Investigational Site
      • Tullahoma, Tennessee, United States, 37388
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Novo Nordisk Investigational Site
      • Dallas, Texas, United States, 75251
        • Novo Nordisk Investigational Site
      • Hurst, Texas, United States, 76054
        • Novo Nordisk Investigational Site
      • Plano, Texas, United States, 75075
        • Novo Nordisk Investigational Site
    • Utah
      • Murray, Utah, United States, 84123
        • Novo Nordisk Investigational Site
    • Virginia
      • Midlothian, Virginia, United States, 23114
        • Novo Nordisk Investigational Site
    • Washington
      • Port Orchard, Washington, United States, 98366
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144
        • Novo Nordisk Investigational Site
      • Milwaukee, Wisconsin, United States, 53209
        • 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 2 diabetes (diagnosed clinically) for 6 months or longer at time of screening (visit 1) - Treated with basal insulin for at least 6 months prior to screening (visit 1) - Current once daily treatment with insulin NPH (Neutral Protamine Hagedorn), insulin detemir or glargine for at least 3 months prior to the screening visit (visit 1) - Current treatment with: a. metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b. metformin in combination with sulfonylurea (SU) or glinide or DPP-IV (dipeptidyl peptidase-4) inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg - HbA1c by central laboratory: a. 7.0 - 9.5% (53 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b. 7.0 - 9.0% (53 - 75 mmol/mol) (both inclusive) in the metformin + other OAD (oral antidiabetic drug) (SU, glinide, DDP-IV inhibitors, AGI) combination group at the screening visit (visit 1) - Body mass index (BMI) equal to or below 40.0 kg/m^2 Exclusion Criteria: - Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days consecutive treatment) and not 3 months prior to the screening visit (visit 1) - Use of GLP-1 (glucagon-like peptide-1) agonists and/or TZDs within the last 3 months prior to screening (visit 1) - Recurrent severe hypoglycaemia (more than 1 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 or 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: Faster-acting insulin aspart (FIAsp)
Meal time faster-acting insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.
Drug: Faster-acting insulin aspart
Mealtime FIAsp administered subcutaneously (s.c., under the skin). Dose individually adjusted.
Drug: Insulin glargine
Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.
ACTIVE_COMPARATOR: Insulin aspart
Meal time insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.
Drug: Insulin glargine
Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.
Drug: Insulin aspart
Mealtime insulin aspart administered subcutaneously (s.c., under the skin). Dose 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
Change From Baseline in HbA1c
Time Frame: Week 0, Week 26
The primary endpoint was change from baseline in HbA1c after 26 weeks of randomized treatment. For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.
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 Increment (Meal Test)
Time Frame: Week 0, week 26
For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.
Week 0, week 26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
Time Frame: From Week 0 to 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 randomized treatment and no later than 1 day after the last day of randomized treatment. A severe or blood glucose (BG) confirmed hypoglycaemic episode was an episode that was severe according to the American Diabetes Association (ADA) classification (an episode that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.
From Week 0 to Week 26.
Change From Baseline in Body Weight
Time Frame: Week 0, week 26
For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.
Week 0, week 26

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.
September 9, 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.
January 22, 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.
January 22, 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).
March 21, 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.
March 22, 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.
March 27, 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.
January 30, 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.
January 10, 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.
January 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.
  • NN1218-3853
  • 2010-024051-93 (EUDRACT_NUMBER)
  • U1111-1118-2509 (OTHER: WHO)
  • CTRI/2014/01/004285 (REGISTRY: Clinical Trials Registry - India (CTRI))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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