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Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes (SUSTAIN™ 2)

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ClinicalTrials.gov Identifier: NCT01930188
Recruitment Status : Completed
First Posted : August 28, 2013
Results First Posted : January 7, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE August 23, 2013
First Posted Date  ICMJE August 28, 2013
Results First Submitted Date  ICMJE December 14, 2017
Results First Posted Date  ICMJE January 7, 2019
Last Update Posted Date June 13, 2019
Actual Study Start Date  ICMJE December 2, 2013
Actual Primary Completion Date October 12, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
Change in HbA1c (Glycosylated Haemoglobin) From Baseline [ Time Frame: Week 0, week 56 ]
Change in HbA1c from baseline until week 56.Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of randomised semaglutide or sitagliptin.
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2013)
Change in HbA1c (Glycosylated Haemoglobin) From Baseline [ Time Frame: Week 0, week 56 ]
Change History Complete list of historical versions of study NCT01930188 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
  • Change in Body Weight From Baseline [ Time Frame: Week 0, week 56 ]
    Change in body weight from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.
  • Change in Fasting Plasma Glucose (FPG) From Baseline [ Time Frame: Week 0, week 56 ]
    Change in fasting plasma glucose from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.
  • Change in Systolic and Diastolic Blood Pressure From Baseline [ Time Frame: Week 0, week 56 ]
    Change in systolic and diastolic blood pressure from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin
  • Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline [ Time Frame: Week 0, week 56 ]
    Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin. The DTSQs questionnaire was used to assess subjects' treatment satisfaction. This questionnaire contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result 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.
  • Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no) [ Time Frame: After 56 weeks treatment ]
    Subjects who achieved HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target (yes/no) after week 56 weeks of treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2013)
  • Change in Body Weight From Baseline [ Time Frame: Week 0, week 56 ]
  • Change in Fasting Plasma Glucose (FPG) From Baseline [ Time Frame: Week 0, week 56 ]
  • Change in Systolic and Diastolic Blood Pressure From Baseline [ Time Frame: Week 0, week 56 ]
  • Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline [ Time Frame: Week 0, week 56 ]
  • Subjects who achieve HbA1c below or equal to 6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target (yes/no) [ Time Frame: After 56 weeks treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes
Official Title  ICMJE Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes (SUSTAIN™ 2 - vs. DPP-4 Inhibitor)
Brief Summary This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or TZD (thiazolidinedione) in subjects with type 2 diabetes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: semaglutide
    For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.
  • Drug: sitagliptin
    Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.
  • Drug: placebo
    Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.
  • Drug: placebo
    For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.
Study Arms  ICMJE
  • Experimental: Semaglutide 0.5 mg + sitagliptin placebo
    Interventions:
    • Drug: semaglutide
    • Drug: placebo
  • Experimental: Semaglutide 1.0 mg + sitagliptin placebo
    Interventions:
    • Drug: semaglutide
    • Drug: placebo
  • Active Comparator: Sitagliptin 100 mg + semaglutide placebo 1.0 mg
    Interventions:
    • Drug: sitagliptin
    • Drug: placebo
  • Active Comparator: Sitagliptin 100 mg + semaglutide placebo 0.5 mg
    Interventions:
    • Drug: sitagliptin
    • Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2016)
1231
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2013)
1200
Actual Study Completion Date  ICMJE October 12, 2015
Actual Primary Completion Date October 12, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Inclusion Criteria: - Japan: Age minimum 20 years - Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 90 days prior to screening with either metformin above or equal to 1500 mg (or maximum tolerated dose), pioglitazone above or equal to 30 mg (or maximum tolerated dose), rosiglitazone above or equal to 4 mg (or maximum tolerated dose) or a combination of either metformin/pioglitazone or metformin/rosiglitazone (doses as for individual therapies). 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 weeks 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 (below or equal to 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value above or equal to 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 m2 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bulgaria,   Czechia,   Hong Kong,   Hungary,   India,   Japan,   Mexico,   Norway,   Portugal,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   Thailand,   Turkey,   Ukraine
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01930188
Other Study ID Numbers  ICMJE NN9535-3626
2012-004827-19 ( EudraCT Number )
U1111-1135-8730 ( Other Identifier: WHO )
132366 ( Other Identifier: JapicCTI )
CTRI/2014/05/004626 ( Registry Identifier: Clinical Trial Registry India (CTRI) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date May 2019

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