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AzTrials

DiabetesPhase 3SUSTAIN™ 4NCT02128932

Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

A Phase 3 study testing semaglutide and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 231 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 2
What is being tested?
semaglutide and insulin glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,089 participants
Where
231 sitesin 15 countries
Study dates
4 Aug 2014to 3 Sep 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, 18 years or older at the time of signing informed consent
  • Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
  • HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive

Who cannot join

  • Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential 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
  • Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
  • Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
  • History of chronic or idiopathic acute pancreatitis
  • Screening calcitonin value greater than or equal to 50 ng/L
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
Show all 12Show fewer
  • Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 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
  • Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
  • Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
  • Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures

Trial locations and contacts

231 sites in 15 countries.

231 sites in 15 countries

United States136 sites

  • Novo Nordisk Investigational Site

    Albuquerque, New Mexico, 87108

  • Novo Nordisk Investigational Site

    Altoona, Pennsylvania, 16602

  • Novo Nordisk Investigational Site

    Amarillo, Texas, 79106

  • Novo Nordisk Investigational Site

    Anaheim, California, 92801

  • Novo Nordisk Investigational Site

    Arlington, Virginia, 22206

  • Novo Nordisk Investigational Site

    Austin, Texas, 78756

  • Novo Nordisk Investigational Site

    Avon, Indiana, 46123

  • Novo Nordisk Investigational Site

    Beaver, Pennsylvania, 15009

  • Novo Nordisk Investigational Site

    Berlin, New Jersey, 08009

  • Novo Nordisk Investigational Site

    Birmingham, Alabama, 35216

  • Novo Nordisk Investigational Site

    Brooklyn, New York, 11229

  • Novo Nordisk Investigational Site

    Buckley, Michigan, 49620

  • Novo Nordisk Investigational Site

    Butte, Montana, 59701

  • Novo Nordisk Investigational Site

    Canal Fulton, Ohio, 44614

  • Novo Nordisk Investigational Site

    Carlisle, Ohio, 45005

  • Novo Nordisk Investigational Site

    Carmichael, California, 95608

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37404

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60611

  • Novo Nordisk Investigational Site

    Chula Vista, California, 91911

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45219

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45227

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45242

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45255

  • Novo Nordisk Investigational Site

    Clairton, Pennsylvania, 15025-3730

  • Novo Nordisk Investigational Site

    Clearwater, Florida, 33761

  • Novo Nordisk Investigational Site

    Cleveland, Ohio, 44122

  • Novo Nordisk Investigational Site

    Colorado Springs, Colorado, 80909

  • Novo Nordisk Investigational Site

    Conyers, Georgia, 30013

  • Novo Nordisk Investigational Site

    Cooper City, Florida, 33024

  • Novo Nordisk Investigational Site

    Corvallis, Oregon, 97330-3737

  • Novo Nordisk Investigational Site

    Council Bluffs, Iowa, 51501

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75251

  • Novo Nordisk Investigational Site

    Denver, Colorado, 80220

  • Novo Nordisk Investigational Site

    Denver, Colorado, 80239-3133

  • Novo Nordisk Investigational Site

    Elk Grove, California, 95758

  • Novo Nordisk Investigational Site

    Fargo, North Dakota, 58104

  • Novo Nordisk Investigational Site

    Flint, Michigan, 48504

  • Novo Nordisk Investigational Site

    Fort Worth, Texas, 76117

  • Novo Nordisk Investigational Site

    Gaffney, South Carolina, 29341

  • Novo Nordisk Investigational Site

    Gilbert, Arizona, 85295

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina, 27408

  • Novo Nordisk Investigational Site

    Gurnee, Illinois, 60031

  • Novo Nordisk Investigational Site

    Hialeah, Florida, 33012

  • Novo Nordisk Investigational Site

    Houston, Texas, 77040

  • Novo Nordisk Investigational Site

    Houston, Texas, 77055

  • Novo Nordisk Investigational Site

    Houston, Texas, 77058

  • Novo Nordisk Investigational Site

    Houston, Texas, 77070

  • Novo Nordisk Investigational Site

    Houston, Texas, 77074

  • Novo Nordisk Investigational Site

    Humble, Texas, 77338

  • Novo Nordisk Investigational Site

    Hurst, Texas, 76054

  • Novo Nordisk Investigational Site

    Hyattsville, Maryland, 20782

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana, 46254

  • Novo Nordisk Investigational Site

    Inglewood, California, 90301

  • Novo Nordisk Investigational Site

    Irving, Texas, 75061-2210

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32205

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32216

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32256

  • Novo Nordisk Investigational Site

    Jersey Shore, Pennsylvania, 17740

  • Novo Nordisk Investigational Site

    Johns Creek, Georgia, 30097

  • Novo Nordisk Investigational Site

    Kenosha, Wisconsin, 53144

  • Novo Nordisk Investigational Site

    Kettering, Ohio, 45429

  • Novo Nordisk Investigational Site

    Kissimmee, Florida, 34741

  • Novo Nordisk Investigational Site

    Knoxville, Tennessee, 37912

  • Novo Nordisk Investigational Site

    La Mesa, California, 91942

  • Novo Nordisk Investigational Site

    Lake Charles, Louisiana, 70601

  • Novo Nordisk Investigational Site

    Lakeland, Florida, 33805

  • Novo Nordisk Investigational Site

    Lansdale, Pennsylvania, 19446-1002

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada, 89109

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada, 89119

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada, 89120

  • Novo Nordisk Investigational Site

    Lexington, Kentucky, 40503

  • Novo Nordisk Investigational Site

    Long Beach, California, 90807

  • Novo Nordisk Investigational Site

    Longview, Texas, 75605

  • Novo Nordisk Investigational Site

    Los Angeles, California, 90057

  • Novo Nordisk Investigational Site

    Madisonville, Kentucky, 42431

  • Novo Nordisk Investigational Site

    Marietta, Georgia, 30060

  • Novo Nordisk Investigational Site

    Marshall, Texas, 75670

  • Novo Nordisk Investigational Site

    Mason, Ohio, 45040-6815

  • Novo Nordisk Investigational Site

    Maumee, Ohio, 43537

  • Novo Nordisk Investigational Site

    Meridian, Idaho, 83646

  • Novo Nordisk Investigational Site

    Metairie, Louisiana, 70002

  • Novo Nordisk Investigational Site

    Miami, Florida, 33135

  • Novo Nordisk Investigational Site

    Miami, Florida, 33156

  • Novo Nordisk Investigational Site

    Miami Lakes, Florida, 33016

  • Novo Nordisk Investigational Site

    Morehead City, North Carolina, 28557

  • Novo Nordisk Investigational Site

    Morganton, North Carolina, 28655

  • Novo Nordisk Investigational Site

    Murrells Inlet, South Carolina, 29576

  • Novo Nordisk Investigational Site

    Natchitoches, Louisiana, 71457-5881

  • Novo Nordisk Investigational Site

    New Windsor, New York, 12553

  • Novo Nordisk Investigational Site

    Norcross, Georgia, 30092

  • Novo Nordisk Investigational Site

    Oceanside, California, 92056

  • Novo Nordisk Investigational Site

    Olympia, Washington, 98502

  • Novo Nordisk Investigational Site

    Orange, California, 92868-2863

  • Novo Nordisk Investigational Site

    Ozark, Alabama, 36360

  • Novo Nordisk Investigational Site

    Paducah, Kentucky, 42003

  • Novo Nordisk Investigational Site

    Park City, Kansas, 67219

  • Novo Nordisk Investigational Site

    Peoria, Illinois, 61602

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19114

  • Novo Nordisk Investigational Site

    Phoenix, Arizona, 85018

  • Novo Nordisk Investigational Site

    Phoenix, Arizona, 85032

  • Novo Nordisk Investigational Site

    Plano, Texas, 75075

  • Novo Nordisk Investigational Site

    Pomona, California, 91767-3008

  • Novo Nordisk Investigational Site

    Rapid City, South Dakota, 57701

  • Novo Nordisk Investigational Site

    Renton, Washington, 98057

  • Novo Nordisk Investigational Site

    Rialto, California, 92376

  • Novo Nordisk Investigational Site

    Rolling Hills Estates, California, 90274

  • Novo Nordisk Investigational Site

    Roseville, California, 95661

  • Novo Nordisk Investigational Site

    Roswell, Georgia, 30076

  • Novo Nordisk Investigational Site

    Salt Lake City, Utah, 84107

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78209

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78229

  • Novo Nordisk Investigational Site

    San Diego, California, 92111

  • Novo Nordisk Investigational Site

    San Mateo, California, 94401

  • Novo Nordisk Investigational Site

    Shelby, North Carolina, 28150

  • Novo Nordisk Investigational Site

    Sherman Oaks, California, 91403

  • Novo Nordisk Investigational Site

    Shreveport, Louisiana, 71107

  • Novo Nordisk Investigational Site

    Spring Hill, Florida, 34609

  • Novo Nordisk Investigational Site

    Spring Valley, California, 91978

  • Novo Nordisk Investigational Site

    St Louis, Missouri, 63128

  • Novo Nordisk Investigational Site

    St Louis, Missouri, 63141

  • Novo Nordisk Investigational Site

    St. George, Utah, 84790

  • Novo Nordisk Investigational Site

    Statesville, North Carolina, 28625

  • Novo Nordisk Investigational Site

    Sterling Heights, Michigan, 48310-3503

  • Novo Nordisk Investigational Site

    Toledo, Ohio, 43623

  • Novo Nordisk Investigational Site

    Toms River, New Jersey, 08755-8050

  • Novo Nordisk Investigational Site

    Trenton, New Jersey, 08611

  • Novo Nordisk Investigational Site

    Troy, Michigan, 48098

  • Novo Nordisk Investigational Site

    Tuscumbia, Alabama, 35674

  • Novo Nordisk Investigational Site

    Tustin, California, 92780

  • Novo Nordisk Investigational Site

    Walnut Creek, California, 94598

  • Novo Nordisk Investigational Site

    Wenatchee, Washington, 98801-2028

  • Novo Nordisk Investigational Site

    West Seneca, New York, 14224

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina, 28401

  • Novo Nordisk Investigational Site

    Winchester, Virginia, 22601

  • Novo Nordisk Investigational Site

    Winter Haven, Florida, 33880

  • Novo Nordisk Investigational Site

    Winter Park, Florida, 32789

Other trials in United States

France19 sites

  • Novo Nordisk Investigational Site

    Bobigny, 93009

  • Novo Nordisk Investigational Site

    Bois-Guillaume, 76320

  • Novo Nordisk Investigational Site

    Bourgoin, 38302

  • Novo Nordisk Investigational Site

    La Roche-sur-Yon, 85295

  • Novo Nordisk Investigational Site

    Le Creusot, 71200

  • Novo Nordisk Investigational Site

    Marseille, 13285

  • Novo Nordisk Investigational Site

    Marseille Cédex 05, 13385

  • Novo Nordisk Investigational Site

    Nanterre, 92014

  • Novo Nordisk Investigational Site

    Narbonne, 11108

  • Novo Nordisk Investigational Site

    Nice, 06202

  • Novo Nordisk Investigational Site

    Paris, 75014

  • Novo Nordisk Investigational Site

    Pierre-Bénite, 69495

  • Novo Nordisk Investigational Site

    Pointe à Pitre, 97159

  • Novo Nordisk Investigational Site

    Rang-du-Fliers, 62180

  • Novo Nordisk Investigational Site

    Saint-Herblain, 44800

  • Novo Nordisk Investigational Site

    Saint-Nazaire, 44600

  • Novo Nordisk Investigational Site

    Strasbourg, 67098

  • Novo Nordisk Investigational Site

    Trinité - La Martinique, 97235

  • Novo Nordisk Investigational Site

    Vénissieux, 69200

Other trials in France

India15 sites

  • Novo Nordisk Investigational Site

    Ahmedabad, Gujarat, 380006

  • Novo Nordisk Investigational Site

    Ahmedabad, Gujarat, 380007

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka, 560092

  • Novo Nordisk Investigational Site

    Chennai, Tamil Nadu, 600031

  • Novo Nordisk Investigational Site

    Indore, Madhya Pradesh, 452010

  • Novo Nordisk Investigational Site

    Kolkata, West Bengal, 700107

  • Novo Nordisk Investigational Site

    Kolkata, 700026

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400008

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400010

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400012

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400022

  • Novo Nordisk Investigational Site

    Mysore, Karnataka, 570001

  • Novo Nordisk Investigational Site

    Mysore, Karnataka, 570004

  • Novo Nordisk Investigational Site

    New Dehli, New Delhi, 110029

  • Novo Nordisk Investigational Site

    New Delhi, 110001

Other trials in India

United Kingdom13 sites

  • Novo Nordisk Investigational Site

    Basingstoke, RG24 9GT

  • Novo Nordisk Investigational Site

    Bristol, BS10 5NB

  • Novo Nordisk Investigational Site

    Harrogate, North Yorkshire, HG2 7SX

  • Novo Nordisk Investigational Site

    Haxey, DN9 2HY

  • Novo Nordisk Investigational Site

    Hull, HU3 2RW

  • Novo Nordisk Investigational Site

    Ipswich, IP4 5PD

  • Novo Nordisk Investigational Site

    Northwood, HA6 2RN

  • Novo Nordisk Investigational Site

    Plymouth, PL6 8BQ

  • Novo Nordisk Investigational Site

    Salford, M6 8HD

  • Novo Nordisk Investigational Site

    Sidcup, DA14 6LT

  • Novo Nordisk Investigational Site

    Soham, CB7 5JD

  • Novo Nordisk Investigational Site

    Swansea, SA2 8PP

  • Novo Nordisk Investigational Site

    Taunton, TA1 5DA

Other trials in United Kingdom

Germany12 sites

  • Novo Nordisk Investigational Site

    Berlin, 10409

  • Novo Nordisk Investigational Site

    Essen, 45276

  • Novo Nordisk Investigational Site

    Jerichow, 39319

  • Novo Nordisk Investigational Site

    Lampertheim, 68623

  • Novo Nordisk Investigational Site

    Ludwigshafen, 67059

  • Novo Nordisk Investigational Site

    Münster, 48145

  • Novo Nordisk Investigational Site

    Neuwied, 56564

  • Novo Nordisk Investigational Site

    Rehlingen-Siersburg, 66780

  • Novo Nordisk Investigational Site

    Rostock, 18057

  • Novo Nordisk Investigational Site

    Saint Ingbert-Oberwürzbach, 66386

  • Novo Nordisk Investigational Site

    Stuttgart, 70378

  • Novo Nordisk Investigational Site

    Wangen, 88239

Other trials in Germany

Romania5 sites

  • Novo Nordisk Investigational Site

    Bucharest, 011234

  • Novo Nordisk Investigational Site

    Cluj-Napoca, Cluj, 400006

  • Novo Nordisk Investigational Site

    Iași, 700469

  • Novo Nordisk Investigational Site

    Oradea, Bihor County, 410469

  • Novo Nordisk Investigational Site

    Piteşti, Argeş, 110084

Other trials in Romania

Slovakia5 sites

  • Novo Nordisk Investigational Site

    Košice, 04011

  • Novo Nordisk Investigational Site

    Moldava nad Bodvou, 045 01

  • Novo Nordisk Investigational Site

    Piešťany, 92101

  • Novo Nordisk Investigational Site

    Púchov, 02001

  • Novo Nordisk Investigational Site

    Trenčín, 91101

Other trials in Slovakia

South Africa5 sites

  • Novo Nordisk Investigational Site

    Cape Town, Western Cape, 7450

  • Novo Nordisk Investigational Site

    Durban, KwaZulu-Natal, 4001

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 1829

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 2001

  • Novo Nordisk Investigational Site

    Pretoria, Gauteng, 0183

Other trials in South Africa

Argentina4 sites

  • Novo Nordisk Investigational Site

    Buenos Aires, C1425AGC

  • Novo Nordisk Investigational Site

    CABA, C1119ACN

  • Novo Nordisk Investigational Site

    Capital Federal, C1056ABJ

  • Novo Nordisk Investigational Site

    Godoy Cruz, M5501ARP

Other trials in Argentina

Croatia4 sites

  • Novo Nordisk Investigational Site

    Čakovec, 40000

  • Novo Nordisk Investigational Site

    Karlovac, 47000

  • Novo Nordisk Investigational Site

    Krapinske Toplice, 49217

  • Novo Nordisk Investigational Site

    Zagreb, 10 000

Other trials in Croatia

Mexico4 sites

  • Novo Nordisk Investigational Site

    Aguascalientes, 20230

  • Novo Nordisk Investigational Site

    Distrito Federal, México, D.F., 14080

  • Novo Nordisk Investigational Site

    Guadalajara, Jalisco, 44150

  • Novo Nordisk Investigational Site

    México D.F., México, D.F., 11550

Other trials in Mexico

Netherlands3 sites

  • Novo Nordisk Investigational Site

    Amsterdam, 1105 AZ

  • Novo Nordisk Investigational Site

    Hoofddorp, 2134 TM

  • Novo Nordisk Investigational Site

    Rotterdam, 3039 BD

Other trials in Netherlands

Slovenia3 sites

  • Novo Nordisk Investigational Site

    Koper, SI-6000

  • Novo Nordisk Investigational Site

    Ljubljana, 1525

  • Novo Nordisk Investigational Site

    Novo Mesto, 8000

Other trials in Slovenia

North Macedonia2 sites

  • Novo Nordisk Investigational Site

    Skopje, 1000

  • Novo Nordisk Investigational Site

    Tetovo, 1220

Other trials in North Macedonia

Puerto Rico1 site

  • Novo Nordisk Investigational Site

    Ponce, 00717

Other trials in Puerto Rico

About this study

Official title: Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as Add on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.

Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • semaglutideDrug

    Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.

  • insulin glargineDrug

    Injected subcutaneously (under the skin) once daily. Subjects will start on 10 IU once daily and the dose will be adjusted according to fasting plasma glucose.

Study groups in NCT02128932
Study groupRoleWhat they receive
Semaglutide 0.5 mg/weekExperimentalNot described
Receives: Drug: semaglutide
Semaglutide 1.0 mg/weekExperimentalNot described
Receives: Drug: semaglutide
Insulin glargineActive comparatorNot described
Receives: Drug: insulin glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c From Baseline

    Change in HbA1c from baseline to week 30.

    Measured: Week 0, week 30

Secondary outcomes (7)

  1. Change in Body Weight From Baseline

    Change in body weight from baseline to week 30.

    Measured: Week 0, week 30

  2. Change in Fasting Plasma Glucose From Baseline

    Change in fasting plasma glucose from baseline to week 30.

    Measured: Week 0, week 30

  3. Change in Diastolic Blood Pressure.

    Change in diastolic blood pressure from baseline to week 30.

    Measured: Week 0, week 30

  4. Change in Systolic Blood Pressure.

    Change in systolic blood pressure from baseline to week 30.

    Measured: Week 0, week 30

  5. Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™

    The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL. PRO questionnaire (SF-36v2™) measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population. The (SF-36v2™) values displayed are the estimated mean change from baseline to week 30.

    Measured: Week 0, week 30

  6. Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs)

    The Diabetes Treatment Satisfaction Questionnaire (DTSQs) questionnaire was to be used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measured the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The values displayed are the estimated mean change from baseline to week 30.

    Measured: Week 0, week 30

  7. Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE)

    Subjects who achieve HbA1c ≤6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) after 30 weeks of treatment

    Measured: After 30 weeks treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2014 (estimated)
  2. Study start4 Aug 2014
  3. Primary completion3 Sep 2015
  4. Study completion3 Sep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,089 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02128932
Sponsor's protocol ID
NN9535-3625
Other IDs
2013-004392-12, U1111-1146-0211, NL47781.018.14
Acronym
SUSTAIN™ 4
Status last verified
May 2019
First submitted
24 Apr 2014
Last updated
13 Jun 2019
Data monitoring committee
No

Publications

  • Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA1C >/=1.0% AND WEIGHT >/=5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.

    PubMed 30865526

  • Aroda VR, Bain SC, Cariou B, Piletic M, Rose L, Axelsen M, Rowe E, DeVries JH. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. Lancet Diabetes Endocrinol. 2017 May;5(5):355-366. doi: 10.1016/S2213-8587(17)30085-2. Epub 2017 Mar 23.

    PubMed 28344112

  • Kapitza C, Dahl K, Jacobsen JB, Axelsen MB, Flint A. Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Diabetologia. 2017 Aug;60(8):1390-1399. doi: 10.1007/s00125-017-4289-0. Epub 2017 May 19.

    PubMed 28526920

  • Warren M, Chaykin L, Trachtenbarg D, Nayak G, Wijayasinghe N, Cariou B. Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2291-2297. doi: 10.1111/dom.13331. Epub 2018 Jun 7.

    PubMed 29687620

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing semaglutide and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 231 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 231 sites in United States, France, India, United Kingdom, Germany and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c From Baseline (time frame: Week 0, week 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02128932, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.

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