Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007380

Trial Description

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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

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Trial Acronym

SUSTAIN™ 4

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007380
  •   2016/01/27
  •   2014/04/24
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   U1111-1146-0211 
  •   2013-004392-12 
  •   NCT02128932  (ClinicalTrials.gov)
  •   NN9535-3625  (Novo Nordisk A/S)
  •   2013-004392-12 
  •   U1111-1146-0211 
  •   NL47781.018.14 
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Health Condition or Problem studied

  •   Diabetes
  •   Diabetes Mellitus, Type 2
  •   E11 -  Non-insulin-dependent diabetes mellitus
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Interventions/Observational Groups

  •   Drug: semaglutide
  •   Drug: semaglutide
  •   Drug: insulin glargine
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Change in HbA1c from baseline; time frame: Week 0, week 30

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Secondary Outcome

- 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

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Croatia
  •   France
  •   Germany
  •   India
  •   Macedonia, the former Yugoslav Republic of
  •   Mexico
  •   Netherlands
  •   Romania
  •   Slovakia
  •   Slovenia
  •   South Africa
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2014/08/31
  •   1047
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Novo Nordisk A/S
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    •   [---]*
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    • Novo Nordisk A/S
    • Global Clinical Registry (GCR, 1452) 
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    •   [---]*
    •   [---]*
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    • Novo Nordisk 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.