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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name SUSTAIN™ 2

NCTNCT01930188 (opens ClinicalTrials.gov in a new tab)Other idNN9535-3626Other id2012-004827-19Other idU1111-1135-8730Other id132366
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
1,231 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
18 countries

Argentina, Bulgaria, Czechia, Hong Kong, Hungary, India, Japan, Mexico, Norway, Portugal, Romania, Russia, South Africa, Spain, Sweden, Thailand, Turkey (Türkiye), Ukraine

Start
2 Dec 2013
Primary completion
12 Oct 2015
Completion
12 Oct 2015
First posted
28 Aug 2013 (estimated)
Last update posted
13 Jun 2019
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 3

    SUSTAIN™ 2

    NCT01930188

    2 Dec 2013 to 12 Oct 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • semaglutideDrug
  • sitagliptinDrug
  • placeboDrug
  • placeboDrug

Arms4

  • Experimental

    Semaglutide 0.5 mg + sitagliptin placebo

  • Experimental

    Semaglutide 1.0 mg + sitagliptin placebo

  • Active comparator

    Sitagliptin 100 mg + semaglutide placebo 1.0 mg

  • Active comparator

    Sitagliptin 100 mg + semaglutide placebo 0.5 mg

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c (Glycosylated Haemoglobin) From Baseline

    Time frame · Week 0, week 56

    Registry description

    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.

Secondary outcomes(5)

  1. Change in Body Weight From Baseline

    Time frame · Week 0, week 56

    Registry description

    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.

  2. Change in Fasting Plasma Glucose (FPG) From Baseline

    Time frame · Week 0, week 56

    Registry description

    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.

  3. Change in Systolic and Diastolic Blood Pressure From Baseline

    Time frame · Week 0, week 56

    Registry description

    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

  4. Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline

    Time frame · Week 0, week 56

    Registry description

    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.

  5. 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

    Registry description

    Subjects who achieved HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target (yes/no) after week 56 weeks of treatment.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Week 0, week 56

Change in HbA1c (Glycosylated Haemoglobin) From Baseline

GroupValue (percentage of glycosylated haemoglobin)Spread
Semaglutide 0.5 mg + Sitagliptin Placebo-1.320.05
Semaglutide 1.0 mg + Sitagliptin Placebo-1.610.05
Sitagliptin + Semaglutide Placebo-0.550.05
Secondary and other outcome results(5)
Secondary outcomeLeast squares mean· Week 0, week 56

Change in Body Weight From Baseline

GroupValue (kilograms)Spread
Semaglutide 0.5 mg + Sitagliptin Placebo-4.280.25
Semaglutide 1.0 mg + Sitagliptin Placebo-6.130.25
Sitagliptin + Semaglutide Placebo-1.930.26
Secondary outcomeLeast squares mean· Week 0, week 56

Change in Fasting Plasma Glucose (FPG) From Baseline

GroupValue (mg/dL)Spread
Semaglutide 0.5 mg + Sitagliptin Placebo-37.381.79
Semaglutide 1.0 mg + Sitagliptin Placebo-46.721.78
Sitagliptin + Semaglutide Placebo-19.851.88
Secondary outcomeLeast squares mean· Week 0, week 56

Change in Systolic and Diastolic Blood Pressure From Baseline

GroupValue (mmHg)Spread
Semaglutide 0.5 mg + Sitagliptin Placebo-5.070.64
Semaglutide 1.0 mg + Sitagliptin Placebo-5.610.63
Sitagliptin + Semaglutide Placebo-2.290.67
Secondary outcomeLeast squares mean· Week 0, week 56

Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline

GroupValue (Units on a scale)Spread
Semaglutide 0.5 mg + Sitagliptin Placebo5.280.23
Semaglutide 1.0 mg + Sitagliptin Placebo5.910.23
Sitagliptin + Semaglutide Placebo4.450.24
Secondary outcomeNumber· After 56 weeks treatment

Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no)

GroupValue (Subjects)
Semaglutide 0.5 mg + Sitagliptin Placebo215
Semaglutide 1.0 mg + Sitagliptin Placebo270
Sitagliptin + Semaglutide Placebo83

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Semaglutide 1.0 mg + Sitagliptin PlaceboSemaglutide 1.0 mg once-weekly + Sitagliptin placebo once-daily–30 / 409197 / 409
Semaglutide 0.5 mg + Sitagliptin PlaceboSemaglutide 0.5 mg once-weekly + Sitagliptin placebo once-daily–30 / 409208 / 409
Sitagliptin 100 mg + Semaglutide Placebo 1.0 mgSitagliptin 100 mg once-daily + Semaglutide placebo 1.0 mg once-weekly–13 / 20475 / 204
Sitagliptin 100 mg + Semaglutide Placebo 0.5 mgSitagliptin 100 mg once-daily + Semaglutide placebo 0.5 mg once-weekly–16 / 20385 / 203

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies16

Studies that cite this trial.

Studies with results

7 studies on this page

Indexing hint: Randomized controlled trial · 2020

9 results

Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials.

DeSouza et al. 2020The Journal of clinical endocrinology and metabolismcited by 43

PMID 31769496DOI 10.1210/clinem/dgz072PUB-31769496

Rights unknown9 results
Source linkSee results (9)

Indexing hint: Meta-analysis (pooled) · 2020

4 results

Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis.

Lingvay et al. 2020The Journal of clinical endocrinology and metabolismcited by 19

PMID 32827435PMC7549924DOI 10.1210/clinem/dgaa577PUB-32827435

CC BY4 results
Download PDFSee results (4)

PubMed tag: none · 2019

8 results

GREATER COMBINED REDUCTIONS IN HbA1C ≥1.0% AND WEIGHT ≥5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES.

Rodbard et al. 2019Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 17

PMID 30865526DOI 10.4158/ep-2018-0444PUB-30865526

Full text at the publisher8 results
Publisher pageSee results (8)

Indexing hint: Randomized controlled trial · 2019

6 results

Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials.

Jendle et al. 2019Diabetes, obesity & metabolismcited by 17

PMID 31215727PMC6771774DOI 10.1111/dom.13816PUB-31215727

Free to read · publisher termsCC BY-NC6 results
Read at sourceSee results (6)

Indexing hint: Systematic review · 2018

5 results

Comparative efficacy of once-weekly semaglutide and SGLT-2 inhibitors in type 2 diabetic patients inadequately controlled with metformin monotherapy: a systematic literature review and network meta-analysis.

Sharma et al. 2018Current medical research and opinioncited by 24

PMID 29764222DOI 10.1080/03007995.2018.1476332PUB-29764222

Full text at the publisher5 results
Publisher pageSee results (5)

Indexing hint: Randomized controlled trial · 2018

5 results

Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials.

Ahrén et al. 2018Diabetes, obesity & metabolismcited by 122

PMID 29766634PMC6099440DOI 10.1111/dom.13353PUB-29766634

Free to read · publisher termsCC BY-NC5 results
Read at sourceSee results (5)

Indexing hint: Randomized controlled trial · 2017

14 results

Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial.

Ahrén et al. 2017The lancet. Diabetes & endocrinologycited by 408

PMID 28385659DOI 10.1016/s2213-8587(17)30092-xPUB-28385659

Full text at the publisher14 results
Publisher pageSee results (14)

More studies

9 studies on this page

PubMed tag: none · 2023

Cost-Effectiveness of Semaglutide vs. Empagliflozin, Canagliflozin, and Sitagliptin for Treatment of Patients with Type 2 Diabetes in Denmark: A Decision-Analytic Modelling Study.

Pulleyblank et al. 2023PharmacoEconomics - opencited by 1

PMID 37178435PMC10333151DOI 10.1007/s41669-023-00416-zPUB-37178435

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2020

Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk.

Husain et al. 2020Diabetes, obesity & metabolismcited by 154

PMID 31903692PMC7064975DOI 10.1111/dom.13955PUB-31903692

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2020

Once-Weekly Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10.

Capehorn et al. 2020Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 10

PMID 32193837PMC7193006DOI 10.1007/s13300-020-00796-zPUB-32193837

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2020

Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials.

Husain et al. 2020Cardiovascular diabetologycited by 33

PMID 32998732PMC7526237DOI 10.1186/s12933-020-01106-4PUB-32998732

CC BY
Download PDF

Indexing hint: Review · 2019

Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials.

Aroda et al. 2019Diabetes & metabolismcited by 227

PMID 30615985DOI 10.1016/j.diabet.2018.12.001PUB-30615985

Full text at the publisher
Publisher page

PubMed tag: none · 2019

Corrected

Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide.

Fonseca et al. 2019The Journal of clinical endocrinology and metabolismcited by 49

PMID 30938762DOI 10.1210/jc.2018-02685PUB-30938762

Rights unknown
Source linkRead the notice

PubMed tag: none · 2018

Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes.

Petri et al. 2018Diabetes, obesity & metabolismcited by 47

PMID 29748996PMC6099226DOI 10.1111/dom.13358PUB-29748996

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2018

Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme.

DeVries et al. 2018Diabetes, obesity & metabolismcited by 19

PMID 29862621PMC6175309DOI 10.1111/dom.13396PUB-29862621

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2018

Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis.

Carlsson Petri et al. 2018Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 43

PMID 29907893PMC6064581DOI 10.1007/s13300-018-0458-5PUB-29907893

Free to read · publisher termsCC BY-NC
Read at source

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultAhrén 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.
  • ResultAhrén 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.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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