Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes (SUSTAIN™1)

May 28, 2019 updated by: Novo Nordisk A/S
This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes. (SUSTAIN™ 1-Monotherapy).

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.
388

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
    • British Columbia
      • Vancouver, British Columbia, Canada, V6J 1S3
        • Novo Nordisk Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2V 4W3
        • Novo Nordisk Investigational Site
    • Ontario
      • London, Ontario, Canada, N6P 1A9
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M3J 1N2
        • Novo Nordisk Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3T2
        • Novo Nordisk Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Novo Nordisk Investigational Site
      • Trois Rivières, Quebec, Canada, G8T 7A1
        • Novo Nordisk Investigational Site
  • Italy
      • Catania, Italy, 95122
        • Novo Nordisk Investigational Site
      • Pisa, Italy, 56124
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00133
        • Novo Nordisk Investigational Site
      • Rome, Italy, 00168
        • Novo Nordisk Investigational Site
      • Siena, Italy, 53100
        • Novo Nordisk Investigational Site
      • Terni, Italy, 05100
        • Novo Nordisk Investigational Site
  • Japan
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Novo Nordisk Investigational Site
      • Suita-shi, Osaka, Japan, 565-0853
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 103-0027
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 103-0028
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 160-0008
        • Novo Nordisk Investigational Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Novo Nordisk Investigational Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64620
        • Novo Nordisk Investigational Site
    • Tamaulipas
      • Ciudad Madero, Tamaulipas, Mexico, 89440
        • Novo Nordisk Investigational Site
  • Romania
      • Bucharest, Romania, 010507
        • Novo Nordisk Investigational Site
      • Bucharest, Romania, 13682
        • Novo Nordisk Investigational Site
      • Buzau, Romania, 120203
        • Novo Nordisk Investigational Site
      • Galati, Romania, 800578
        • Novo Nordisk Investigational Site
    • Bihor
      • Oradea, Bihor, Romania, 410469
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Novo Nordisk Investigational Site
      • Arkhangelsk, Russian Federation, 163001
        • Novo Nordisk Investigational Site
      • Chelyabinsk, Russian Federation, 454048
        • Novo Nordisk Investigational Site
      • Kazan, Russian Federation, 420073
        • Novo Nordisk Investigational Site
      • Novosibirsk, Russian Federation, 630047
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 194358
        • Novo Nordisk Investigational Site
      • Saint-Petesburg, Russian Federation, 195257
        • Novo Nordisk Investigational Site
      • Saratov, Russian Federation, 410053
        • Novo Nordisk Investigational Site
      • Stavropol, Russian Federation, 355035
        • Novo Nordisk Investigational Site
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6014
        • Novo Nordisk Investigational Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1827
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 1818
        • Novo Nordisk Investigational Site
      • Krugersdorp, Gauteng, South Africa, 1739
        • Novo Nordisk Investigational Site
      • Pretoria, Gauteng, South Africa, 0084
        • Novo Nordisk Investigational Site
      • Sophiatown, Gauteng, South Africa, 2129
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4450
        • Novo Nordisk Investigational Site
      • Umkomaas, KwaZulu-Natal, South Africa, 4170
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Cardiff, United Kingdom, CF5 4AD
        • Novo Nordisk Investigational Site
      • Dundee, United Kingdom, DD2 5NH
        • Novo Nordisk Investigational Site
      • St Helens, United Kingdom, WA9 3DA
        • Novo Nordisk Investigational Site
      • Swansea, United Kingdom, SA2 8PP
        • Novo Nordisk Investigational Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Novo Nordisk Investigational Site
      • Birmingham, Alabama, United States, 35216
        • Novo Nordisk Investigational Site
      • Pell City, Alabama, United States, 35128
        • Novo Nordisk Investigational Site
    • California
      • Hawaiian Gardens, California, United States, 90716
        • Novo Nordisk Investigational Site
      • Lomita, California, United States, 90717
        • Novo Nordisk Investigational Site
      • Los Angeles, California, United States, 90057
        • Novo Nordisk Investigational Site
      • Montclair, California, United States, 91763
        • Novo Nordisk Investigational Site
      • Northridge, California, United States, 91324
        • Novo Nordisk Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80920
        • Novo Nordisk Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32277
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33143
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33144
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33174
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33173
        • Novo Nordisk Investigational Site
      • Miami, Florida, United States, 33015
        • Novo Nordisk Investigational Site
      • Miami Lakes, Florida, United States, 33016
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33026
        • Novo Nordisk Investigational Site
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Novo Nordisk Investigational Site
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Novo Nordisk Investigational Site
      • Franklin, Indiana, United States, 46131
        • Novo Nordisk Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Novo Nordisk Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Novo Nordisk Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Novo Nordisk Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Novo Nordisk Investigational Site
    • New Jersey
      • Belvidere, New Jersey, United States, 07823
        • Novo Nordisk Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Novo Nordisk Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Novo Nordisk Investigational Site
      • Whiteville, North Carolina, United States, 28472
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45255
        • Novo Nordisk Investigational Site
      • Delaware, Ohio, United States, 43015
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Levittown, Pennsylvania, United States, 19056
        • Novo Nordisk Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Novo Nordisk Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • 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

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: - For Japan only: Male or female, age above or equal to 20 years at the time of signing inform consent - Subjects diagnosed with type 2 diabetes and treated with diet and exercise for at least 30 days before screening - HbA1c 7.0 - 10.0 % (53 - 86 mmol/mol) (both inclusive) Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with any glucose lowering agent(s) in a period of 90 days prior to screening. An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value above or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as eGFR (estimated glomerular filtration rate ) below 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association class IV

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 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.
Placebo Comparator: Semaglutide placebo 0.5 mg
Drug: placebo
Once weekly, administrated subcutaneously (s.c. under the skin)
Placebo Comparator: Semaglutide placebo 1.0 mg
Drug: placebo
Once weekly, administrated subcutaneously (s.c. under the skin)
Experimental: Semaglutide 0.5 mg
Drug: semaglutide
Once weekly, administrated subcutaneously (s.c. under the skin)
Experimental: Semaglutide 1.0 mg
Drug: semaglutide
Once weekly, administrated subcutaneously (s.c. under the skin)

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 in HbA1c (Glycosylated Haemoglobin)
Time Frame: Week 0, week 30
Change from baseline (week 0) in HbA1c was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Week 0, week 30

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 in Body Weight
Time Frame: Week 0, week 30
Change from baseline (week 0) in body weight was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Week 0, week 30
Change in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, week 30
Change from baseline (week 0) in FPG was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Week 0, week 30
Change in Systolic and Diastolic Blood Pressure
Time Frame: Week 0, week 30
Change from baseline (week 0) in systolic and diastolic blood pressure was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Week 0, week 30
Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association Target
Time Frame: At 30 weeks of treatment
Percentage of subjects who achieve (yes/no): HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
At 30 weeks of treatment
Subjects Who Achieve (Yes/no):HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target
Time Frame: At 30 weeks of treatment
Percentage of subjects who achieve (yes/no): HbA1c below 6.5% (48 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
At 30 weeks of treatment

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.
February 3, 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.
May 8, 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.
May 8, 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).
February 3, 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.
February 3, 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.
February 4, 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.
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.
  • NN9535-3623
  • 2013-000632-94 (EudraCT Number)
  • U1111-1139-3090 (Other Identifier: WHO)
  • JapicCTI-142442 (Registry Identifier: JAPIC)

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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