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Trial record 1 of 1606 for:    SUSTAIN 4
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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 (SUSTAIN™ 4)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02128932
First Posted: May 1, 2014
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
April 24, 2014
May 1, 2014
April 28, 2017
August 4, 2014
September 3, 2015   (Final data collection date for primary outcome measure)
Change in HbA1c from baseline [ Time Frame: Week 0, week 30 ]
Same as current
Complete list of historical versions of study NCT02128932 on ClinicalTrials.gov Archive Site
  • Change in body weight from baseline [ Time Frame: Week 0, week 30 ]
  • Change in fasting plasma glucose from baseline [ Time Frame: Week 0, week 30 ]
  • Change in systolic and diastolic blood pressure from baseline [ Time Frame: Week 0, week 30 ]
  • Change in patient reported outcome (PRO) questionnaire SF-36v2™ from baseline [ Time Frame: Week 0, week 30 ]
  • Change in patient reported outcome (PRO) questionnaire DTSQs (diabetes treatment satisfaction questionnaire) from baseline [ Time Frame: Week 0, week 30 ]
  • 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 30 weeks treatment ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: semaglutide
    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.
  • Drug: insulin glargine
    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.
  • Experimental: Semaglutide 0.5 mg/week
    Intervention: Drug: semaglutide
  • Experimental: Semaglutide 1.0 mg/week
    Intervention: Drug: semaglutide
  • Active Comparator: Insulin glargine
    Intervention: Drug: insulin glargine
Aroda VR, Bain SC, Cariou B, Piletič 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1089
September 3, 2015
September 3, 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Croatia,   France,   Germany,   India,   Macedonia, The Former Yugoslav Republic of,   Mexico,   Netherlands,   Puerto Rico,   Romania,   Slovakia,   Slovenia,   South Africa,   United Kingdom,   United States
 
 
NCT02128932
NN9535-3625
2013-004392-12 ( EudraCT Number )
U1111-1146-0211 ( Other Identifier: WHO )
NL47781.018.14 ( Registry Identifier: National Registry in The Netherlands )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP