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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01885208
First received: June 20, 2013
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: semaglutide
Drug: exenatide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change from baseline in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in body weight [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Change from baseline in systolic and diastolic blood pressure [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Change from baseline in patient reported outcome (PRO) questionnaire Diabetes Treatment Satisfaction Questionnaire status (DTSQs) [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 798
Study Start Date: December 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885208

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Clinical Trial Call Center
Anniston, Alabama, United States, 36207
Novo Nordisk Clinical Trial Call Center
Birmingham, Alabama, United States, 35216
Novo Nordisk Clinical Trial Call Center
Pell City, Alabama, United States, 35128
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Glendale, Arizona, United States, 85306-4652
Novo Nordisk Clinical Trial Call Center
Mesa, Arizona, United States, 85213
Novo Nordisk Clinical Trial Call Center
Phoenix, Arizona, United States, 85027
United States, California
Novo Nordisk Clinical Trial Call Center
Burbank, California, United States, 91505
Novo Nordisk Clinical Trial Call Center
Hawaiian Gardens, California, United States, 90716
Novo Nordisk Clinical Trial Call Center
Lomita, California, United States, 90717
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90017
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90057
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90022
Novo Nordisk Clinical Trial Call Center
Northridge, California, United States, 91325
Novo Nordisk Clinical Trial Call Center
San Diego, California, United States, 92108
Novo Nordisk Clinical Trial Call Center
Tustin, California, United States, 92780
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Colorado Springs, Colorado, United States, 80906
Novo Nordisk Clinical Trial Call Center
Colorado Springs, Colorado, United States, 80909
United States, Florida
Novo Nordisk Clinical Trial Call Center
Bradenton, Florida, United States, 34208
Novo Nordisk Clinical Trial Call Center
Coral Gables, Florida, United States, 33134
Novo Nordisk Clinical Trial Call Center
Hialeah, Florida, United States, 33012
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, United States, 32207
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33174
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33144
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33186
Novo Nordisk Clinical Trial Call Center
Miami Lakes, Florida, United States, 33016
Novo Nordisk Clinical Trial Call Center
Plantation, Florida, United States, 33324
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Savannah, Georgia, United States, 31406
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60634
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Franklin, Indiana, United States, 46131-9121
Novo Nordisk Clinical Trial Call Center
Greenfield, Indiana, United States, 46140
Novo Nordisk Clinical Trial Call Center
Muncie, Indiana, United States, 47304
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Crestview Hills, Kentucky, United States, 41017-3464
Novo Nordisk Clinical Trial Call Center
Louisville, Kentucky, United States, 40213
Novo Nordisk Clinical Trial Call Center
Madisonville, Kentucky, United States, 42431-1661
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Hyattsville, Maryland, United States, 20782
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Kalamazoo, Michigan, United States, 49009
United States, Missouri
Novo Nordisk Clinical Trial Call Center
St. Louis, Missouri, United States, 63141
United States, Nevada
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89103
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Mine Hill, New Jersey, United States, 07803
United States, New Mexico
Novo Nordisk Clinical Trial Call Center
Albuquerque, New Mexico, United States, 87102
United States, New York
Novo Nordisk Clinical Trial Call Center
North Massapequa, New York, United States, 11758-1802
Novo Nordisk Clinical Trial Call Center
Syracuse, New York, United States, 13210
Novo Nordisk Clinical Trial Call Center
West Seneca, New York, United States, 14224
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Greensboro, North Carolina, United States, 27408
Novo Nordisk Clinical Trial Call Center
Hickory, North Carolina, United States, 28601
Novo Nordisk Clinical Trial Call Center
Whiteville, North Carolina, United States, 28472
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Akron, Ohio, United States, 44311
Novo Nordisk Clinical Trial Call Center
Cleveland, Ohio, United States, 44122
Novo Nordisk Clinical Trial Call Center
Delaware, Ohio, United States, 43015
United States, Oregon
Novo Nordisk Clinical Trial Call Center
Corvallis, Oregon, United States, 97330-3737
Novo Nordisk Clinical Trial Call Center
Portland, Oregon, United States, 97239
Novo Nordisk Clinical Trial Call Center
Portland, Oregon, United States, 97210
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Lansdale, Pennsylvania, United States, 19446-1002
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Charleston, South Carolina, United States, 29407
Novo Nordisk Clinical Trial Call Center
Mount Pleasant, South Carolina, United States, 29464
Novo Nordisk Clinical Trial Call Center
Mt. Pleasant, South Carolina, United States, 29464
Novo Nordisk Clinical Trial Call Center
Murrells Inlet, South Carolina, United States, 29576
Novo Nordisk Clinical Trial Call Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, United States, 37404
United States, Texas
Novo Nordisk Clinical Trial Call Center
Austin, Texas, United States, 78731
Novo Nordisk Clinical Trial Call Center
Carrollton, Texas, United States, 75010
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75225
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75390-8858
Novo Nordisk Clinical Trial Call Center
Fort Worth, Texas, United States, 76117
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77036
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77072
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77024
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77008
Novo Nordisk Clinical Trial Call Center
Irving, Texas, United States, 75039
Novo Nordisk Clinical Trial Call Center
Katy, Texas, United States, 77450
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78212
Novo Nordisk Clinical Trial Call Center
Sugarland, Texas, United States, 77478
Novo Nordisk Clinical Trial Call Center
Sugarland, Texas, United States, 77479
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Alexandria, Virginia, United States, 22304
Argentina
Buenos Aires, Argentina, C1425AGC
Croatia
Osijek, Croatia, 31 000
Finland
Kerava, Finland, FI-04200
France
Nanterre, France, 92014
Germany
Dresden, Germany, 01307
Greece
Athens, Greece, 17562
Italy
Milano, Italy, 20132
Netherlands
Amsterdam, Netherlands, 1066 EC
Puerto Rico
Novo Nordisk Clinical Trial Call Center
Caguas, Puerto Rico, 00725
Novo Nordisk Clinical Trial Call Center
Manati, Puerto Rico, 00674
Serbia
Kragujevac, Serbia, 34000
Switzerland
Basel, Switzerland, 4031
United Kingdom
Bath, United Kingdom, BA1 2RG
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01885208     History of Changes
Other Study ID Numbers: NN9535-3624, 2012-004826-92, U1111-1135-8647
Study First Received: June 20, 2013
Last Updated: April 23, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Croatia: Ministry of Health and Social Care
Finland: Finnish Medicines Agency
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health & Social Solidarity - National Organizaion for Medicines (EOF)
Italy: The Italian Medicines Agency
Netherlands: Dutch Health Care Inspectorate
Serbia: Agency for Drugs and Medicinal Devices
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014