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Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes (SUSTAIN™ 3)

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ClinicalTrials.gov Identifier: NCT01885208
Recruitment Status : Completed
First Posted : June 24, 2013
Results First Posted : March 30, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: semaglutide Drug: exenatide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 813 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes (SUSTAIN™ 3 - vs. QW GLP-1)
Actual Study Start Date : December 2, 2013
Actual Primary Completion Date : July 13, 2015
Actual Study Completion Date : July 13, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Semaglutide 1.0 mg Drug: semaglutide
One dose of 1.0 mg semaglutide administered subcutaneously (s.c., under the skin) once-weekly

Active Comparator: Exenatide ER 2.0 mg Drug: exenatide
One dose of 2.0 mg exenatide ER administered subcutaneously (s.c., under the skin) once-weekly
Other Name: Bydureon®




Primary Outcome Measures :
  1. Change From Baseline in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 56 ]
    Mean change in HbA1c from baseline to week 56.


Secondary Outcome Measures :
  1. Change From Baseline in Body Weight [ Time Frame: Week 0, week 56 ]
    Mean change in body weight from baseline to week 56.

  2. Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 56 ]
    Mean change in FPG from baseline to week 56.

  3. Change From Baseline in Systolic and Diastolic Blood Pressure [ Time Frame: Week 0, week 56 ]
    Mean changes in systolic and diastolic blood pressure from baseline to week 56.

  4. Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) [ Time Frame: Week 0, week 56 ]
    The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measures 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.

  5. Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target: (Yes/no) [ Time Frame: After 56 weeks' treatment ]
    The endpoint considered HbA1c ≤6.5% (48 mmol/mol) as per the AACE target after 56 weeks of treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 OADs (Metformin equal to or above 1500 mg or maximum tolerated dose and/or thiazolidinedione (TZD) and sulfonylureas (SUs) equal to or above half of maximum dose allowed according to national label) for at least 90 days prior to screening. Stable is defined as unchanged medication and unchanged dose
  • HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive)

Exclusion Criteria:

  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measures as required by local law or practice)
  • 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 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 inter-current illness
  • History of chronic or idiopathic acute pancreatitis
  • Screening calcitonin value equal to or above 50 ng/L (pg/mL)
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
  • Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 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 (NYHA) class IV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885208


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Locations
United States, Alabama
Novo Nordisk Investigational Site
Anniston, Alabama, United States, 36207
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35216
Novo Nordisk Investigational Site
Pell City, Alabama, United States, 35128
United States, Arizona
Novo Nordisk Investigational Site
Glendale, Arizona, United States, 85306-4652
Novo Nordisk Investigational Site
Mesa, Arizona, United States, 85213
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85027
United States, California
Novo Nordisk Investigational Site
Burbank, California, United States, 91505
Novo Nordisk Investigational Site
Hawaiian Gardens, California, United States, 90716
Novo Nordisk Investigational Site
Lomita, California, United States, 90717
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90017
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90022
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90057
Novo Nordisk Investigational Site
Northridge, California, United States, 91324
Novo Nordisk Investigational Site
Northridge, California, United States, 91325
Novo Nordisk Investigational Site
San Diego, California, United States, 92108
Novo Nordisk Investigational Site
Tustin, California, United States, 92780
United States, Colorado
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80906
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80909
United States, Florida
Novo Nordisk Investigational Site
Bradenton, Florida, United States, 34201
Novo Nordisk Investigational Site
Brandon, Florida, United States, 33511
Novo Nordisk Investigational Site
Coral Gables, Florida, United States, 33134
Novo Nordisk Investigational Site
Hialeah, Florida, United States, 33012
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Jacksonville, Florida, United States, 32207
Novo Nordisk Investigational Site
Miami Lakes, Florida, United States, 33016
Novo Nordisk Investigational Site
Miami, Florida, United States, 33144
Novo Nordisk Investigational Site
Miami, Florida, United States, 33145
Novo Nordisk Investigational Site
Miami, Florida, United States, 33174
Novo Nordisk Investigational Site
Plantation, Florida, United States, 33324
United States, Georgia
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Savannah, Georgia, United States, 31406
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60634
United States, Indiana
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Franklin, Indiana, United States, 46131
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Greenfield, Indiana, United States, 46140
Novo Nordisk Investigational Site
Muncie, Indiana, United States, 47304
United States, Kentucky
Novo Nordisk Investigational Site
Crestview Hills, Kentucky, United States, 41017-3464
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Louisville, Kentucky, United States, 40213
Novo Nordisk Investigational Site
Madisonville, Kentucky, United States, 42431
United States, Maryland
Novo Nordisk Investigational Site
Hyattsville, Maryland, United States, 20782
United States, Michigan
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Kalamazoo, Michigan, United States, 49009
United States, Missouri
Novo Nordisk Investigational Site
Saint Louis, Missouri, United States, 63141
United States, Nevada
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89103
United States, New Jersey
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Mine Hill, New Jersey, United States, 07803
United States, New Mexico
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Albuquerque, New Mexico, United States, 87102
United States, New York
Novo Nordisk Investigational Site
North Massapequa, New York, United States, 11758-1802
Novo Nordisk Investigational Site
Syracuse, New York, United States, 13210
Novo Nordisk Investigational Site
West Seneca, New York, United States, 14224
United States, North Carolina
Novo Nordisk Investigational Site
Greensboro, North Carolina, United States, 27408
Novo Nordisk Investigational Site
Hickory, North Carolina, United States, 28601
Novo Nordisk Investigational Site
Whiteville, North Carolina, United States, 28472
United States, Ohio
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Akron, Ohio, United States, 44311
Novo Nordisk Investigational Site
Cleveland, Ohio, United States, 44122
Novo Nordisk Investigational Site
Delaware, Ohio, United States, 43015
United States, Oregon
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Corvallis, Oregon, United States, 97330-3737
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97210
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Novo Nordisk Investigational Site
Lansdale, Pennsylvania, United States, 19446-1002
Novo Nordisk Investigational Site
Norristown, Pennsylvania, United States, 19401
United States, South Carolina
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Charleston, South Carolina, United States, 29407
Novo Nordisk Investigational Site
Mount Pleasant, South Carolina, United States, 29464
Novo Nordisk Investigational Site
Murrells Inlet, South Carolina, United States, 29576
Novo Nordisk Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
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Chattanooga, Tennessee, United States, 37404
United States, Texas
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Austin, Texas, United States, 78731
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Carrollton, Texas, United States, 75010
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Dallas, Texas, United States, 75225
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75390-8858
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Fort Worth, Texas, United States, 76117
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Houston, Texas, United States, 77008
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Houston, Texas, United States, 77024
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Houston, Texas, United States, 77040
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Houston, Texas, United States, 77072
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Irving, Texas, United States, 75039
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Katy, Texas, United States, 77450
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San Antonio, Texas, United States, 78245
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Sugar Land, Texas, United States, 77478
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Sugar Land, Texas, United States, 77479
United States, Virginia
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Alexandria, Virginia, United States, 22304
Argentina
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Buenos Aires, Argentina, C1250AAN
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Buenos Aires, Argentina, C1425AGC
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Caba, Argentina, C1179AAB
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Lanus Este, Argentina, B1824KAJ
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Mar del Plata, Argentina, B7600GWV
Croatia
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Karlovac, Croatia, 47000
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Osijek, Croatia, 31 000
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Slavonski Brod, Croatia, 35 000
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Virovitica, Croatia, 33000
Novo Nordisk Investigational Site
Zagreb, Croatia, 10 000
Finland
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Helsinki, Finland, 00260
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Helsinki, Finland, FI-00100
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Kerava, Finland, FI-04200
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Oulu, Finland, 90220
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Turku, Finland, 20520
France
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Chalons-en-Champagne Cedex, France, 51005
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Corbeil Essonnes, France, 91106
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LA ROCHELLE cedex, France, 17019
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Le Creusot, France, 71200
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Nanterre, France, 92014
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Roubaix, France, 59100
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Strasbourg, France, 67000
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Venissieux, France, 69200
Germany
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Dresden, Germany, 01219
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Dresden, Germany, 01307
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Duisburg, Germany, 47051
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Hohenmölsen, Germany, 06679
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Mannheim, Germany, 68163
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Oldenburg, Germany, 23758
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Rehlingen-Siersburg, Germany, 66780
Novo Nordisk Investigational Site
Völklingen, Germany, 66333
Greece
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Athens, Greece, GR-12462
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Athens, Greece, GR-14233
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Athens, Greece, GR-17562
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Piraeus, Greece, GR-18536
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Thessaloniki, Greece, GR-54636
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Thessaloniki, Greece, GR-57010
Italy
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Bologna, Italy, 40138
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Città di Castello, Italy, 06012
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Milano, Italy, 20132
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Palermo, Italy, 90127
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Pavia, Italy, 27100
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Roma, Italy, 00161
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Siena, Italy, 53100
Netherlands
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Amsterdam, Netherlands, 1066 EC
Novo Nordisk Investigational Site
Apeldoorn, Netherlands, 7334 DZ
Novo Nordisk Investigational Site
Delft, Netherlands, 2625 AD
Novo Nordisk Investigational Site
Hoofddorp, Netherlands, 2134 TM
Novo Nordisk Investigational Site
Leeuwarden, Netherlands, 8934 AD
Novo Nordisk Investigational Site
Rotterdam, Netherlands, 3021 HC
Novo Nordisk Investigational Site
Rotterdam, Netherlands, 3039 BD
Novo Nordisk Investigational Site
Venlo, Netherlands, 5912 BL
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Zoetermeer, Netherlands, 2725 NA
Puerto Rico
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Caguas, Puerto Rico, 00725
Novo Nordisk Investigational Site
Manati, Puerto Rico, 00674
Serbia
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Belgrade, Serbia, 11000
Novo Nordisk Investigational Site
Belgrade, Serbia, 11080
Novo Nordisk Investigational Site
Kragujevac, Serbia, 34000
Novo Nordisk Investigational Site
Novi Sad, Serbia, 21000
Switzerland
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Basel, Switzerland, 4031
Novo Nordisk Investigational Site
Genève 14, Switzerland, 1211
Novo Nordisk Investigational Site
Luzern 16, Switzerland, 6000
Novo Nordisk Investigational Site
St. Gallen, Switzerland, 9007
Novo Nordisk Investigational Site
Zollikerberg, Switzerland, 8125
United Kingdom
Novo Nordisk Investigational Site
Ayr, United Kingdom, KA6 6DX
Novo Nordisk Investigational Site
Bath, United Kingdom, BA1 3NG
Novo Nordisk Investigational Site
Bradford-on-Avon, United Kingdom, BA15 1DQ
Novo Nordisk Investigational Site
Haxey, United Kingdom, DN9 2HY
Novo Nordisk Investigational Site
Headington, United Kingdom, OX3 7LE
Novo Nordisk Investigational Site
Rotherham, United Kingdom, S651DA
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01885208     History of Changes
Other Study ID Numbers: NN9535-3624
2012-004826-92 ( EudraCT Number )
U1111-1135-8647 ( Other Identifier: WHO )
First Posted: June 24, 2013    Key Record Dates
Results First Posted: March 30, 2018
Last Update Posted: June 7, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists