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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
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : December 2, 2013
Actual Primary Completion Date : October 12, 2015
Actual Study Completion Date : October 12, 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Semaglutide 0.5 mg + sitagliptin placebo 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: placebo
Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.
Experimental: Semaglutide 1.0 mg + sitagliptin placebo 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: placebo
Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.
Active Comparator: Sitagliptin 100 mg + semaglutide placebo 1.0 mg 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
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.
Active Comparator: Sitagliptin 100 mg + semaglutide placebo 0.5 mg 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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c (glycosylated haemoglobin) from baseline [ Time Frame: Week 0, week 56 ]

Secondary Outcome Measures :
  1. Change in body weight from baseline [ Time Frame: Week 0, week 56 ]
  2. Change in fasting plasma glucose (FPG) from baseline [ Time Frame: Week 0, week 56 ]
  3. Change in systolic and diastolic blood pressure from baseline [ Time Frame: Week 0, week 56 ]
  4. Change in patient reported outcome (PRO) questionnaire Diabetes Treatment Satisfaction Questionnaire status (DTSQs) from baseline [ Time Frame: Week 0, week 56 ]
  5. 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 ]

Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT01930188


  Show 141 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

Publications of Results:
Ahrén B, Comas LM, Kumar H, Sargin M, Derving Karsbøl J, Jacobsen SH, Chow F. Efficacy and Safety of Once-weekly Semaglutide vs Sitagliptin as add-on to Metformin and/or Thiazolidinediones After 56 Weeks in Subjects With Type 2 Diabetes (SUSTAIN 2). Oral Presentation 12 Jun 2016 at American Diabetes Association - 76th Annual Scientific Sessions.
Ahrén B, Masmiquel L, Kumar H, Sargin M, Derving Karsbøl J, Jacobsen SH, Chow F. Efficacy and Safety of Once-weekly Semaglutide vs Sitagliptin as add-on to Metformin and/or Thiazolidinediones After 56 Weeks in Subjects With Type 2 Diabetes (SUSTAIN 2). ePoster #767 presented 12 Sep 2016 at European Association for the Study of Diabetes - 52nd Annual Meeting.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01930188     History of Changes
Other Study ID Numbers: 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) )
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
 Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action