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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01930188
First received: August 23, 2013
Last updated: August 6, 2014
Last verified: August 2014

August 23, 2013
August 6, 2014
December 2013
October 2015   (final data collection date for primary outcome measure)
Change in HbA1c (glycosylated haemoglobin) from baseline [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01930188 on ClinicalTrials.gov Archive Site
  • Change in body weight from baseline [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose (FPG) from baseline [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Change in systolic and diastolic blood pressure from baseline [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Change in patient reported outcome (PRO) questionnaire Diabetes Treatment Satisfaction Questionnaire status (DTSQs) from baseline [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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)

This trial is conducted in Africa, Asia, Europe and South and North 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1200
October 2015
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Bulgaria,   Czech Republic,   Hong Kong,   Hungary,   India,   Japan,   Mexico,   Norway,   Portugal,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   Thailand,   Turkey,   Ukraine
 
NCT01930188
NN9535-3626, 2012-004827-19, U1111-1135-8730, 132366, CTRI/2014/05/004626
No
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
August 2014

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