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)

May 28, 2019 updated by: Novo Nordisk A/S

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1231

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425AGC
        • Novo Nordisk Investigational Site
      • Caba, Argentina, C1179AAB
        • Novo Nordisk Investigational Site
      • Caba, Argentina
        • Novo Nordisk Investigational Site
      • Mar del Plata, Argentina, B7600GNY
        • Novo Nordisk Investigational Site
  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Novo Nordisk Investigational Site
      • Haskovo, Bulgaria, 6300
        • Novo Nordisk Investigational Site
      • Petrich, Bulgaria, 2850
        • Novo Nordisk Investigational Site
      • Ruse, Bulgaria, 7000
        • Novo Nordisk Investigational Site
      • Sliven, Bulgaria, 8800
        • Novo Nordisk Investigational Site
      • Smolyan, Bulgaria, 4700
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1233
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1336
        • Novo Nordisk Investigational Site
      • Stara Zagora, Bulgaria, 6000
        • Novo Nordisk Investigational Site
      • Vratsa, Bulgaria, 3001
        • Novo Nordisk Investigational Site
  • Czechia
      • Chrudim, Czechia, 537 01
        • Novo Nordisk Investigational Site
      • Ostrava, Czechia, 707 02
        • Novo Nordisk Investigational Site
      • Plzen, Czechia, 304 60
        • Novo Nordisk Investigational Site
      • Praha 4- Chodov, Czechia, 149 00
        • Novo Nordisk Investigational Site
      • Praha 5, Czechia, 150 00
        • Novo Nordisk Investigational Site
  • Hong Kong
      • Shatin, New Territories, Hong Kong
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, H-1134
        • Novo Nordisk Investigational Site
      • Budapest, Hungary, 1076
        • Novo Nordisk Investigational Site
      • Debrecen, Hungary, 4043
        • Novo Nordisk Investigational Site
      • Szeged, Hungary, H-6720
        • Novo Nordisk Investigational Site
      • Szombathely, Hungary, H-9700
        • Novo Nordisk Investigational Site
  • India
      • New Delhi, India, 110017
        • Novo Nordisk Investigational Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500003
        • Novo Nordisk Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • Novo Nordisk Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560034
        • Novo Nordisk Investigational Site
      • Bangalore, Karnataka, India, 560054
        • Novo Nordisk Investigational Site
    • Kerala
      • Kochi, Kerala, India, 682041
        • Novo Nordisk Investigational Site
      • Kozhikode, Kerala, India, 673017
        • Novo Nordisk Investigational Site
      • Trivandrum, Kerala, India, 695011
        • Novo Nordisk Investigational Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India, 411001
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India, 411004
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India, 411040
        • Novo Nordisk Investigational Site
    • Orissa
      • Bhubaneswar, Orissa, India, 751019
        • Novo Nordisk Investigational Site
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Novo Nordisk Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600116
        • Novo Nordisk Investigational Site
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Novo Nordisk Investigational Site
      • Kolkata, West Bengal, India, 700054
        • Novo Nordisk Investigational Site
  • Japan
      • Asahikawa-shi, Hokkaido, Japan, 070-0002
        • Novo Nordisk Investigational Site
      • Ibaraki, Japan, 311-0113
        • Novo Nordisk Investigational Site
      • Kashiwara-shi, Osaka, Japan, 582-0005
        • Novo Nordisk Investigational Site
      • Kitakyushu-shi, Fukuoka, Japan, 800 0252
        • Novo Nordisk Investigational Site
      • Mitaka-shi, Tokyo, Japan, 181-0013
        • Novo Nordisk Investigational Site
      • Mito-shi, Ibaraki, Japan, 310-0826
        • Novo Nordisk Investigational Site
      • Miyazaki, Japan, 880-0034
        • Novo Nordisk Investigational Site
      • Okayama-shi, Okayama, Japan, 700 8505
        • Novo Nordisk Investigational Site
      • Osaka, Japan, 569-1045
        • Novo Nordisk Investigational Site
      • Osaka-shi, Osaka, Japan, 532 0003
        • Novo Nordisk Investigational Site
      • Osaka-shi, Osaka, Japan
        • Novo Nordisk Investigational Site
      • Sapporo-shi, Hokkaido, Japan, 060-0001
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 103-0027
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 125-0054
        • Novo Nordisk Investigational Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Novo Nordisk Investigational Site
      • Aguascalientes, Mexico, 20129
        • Novo Nordisk Investigational Site
    • Hidalgo
      • Pachuca, Hidalgo, Mexico, 42084
        • Novo Nordisk Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Novo Nordisk Investigational Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64620
        • Novo Nordisk Investigational Site
  • Norway
      • Hamar, Norway, 2317
        • Novo Nordisk Investigational Site
      • Kløfta, Norway, 2040
        • Novo Nordisk Investigational Site
      • Kongsvinger, Norway, 2212
        • Novo Nordisk Investigational Site
      • Stavanger, Norway, 4005
        • Novo Nordisk Investigational Site
      • Ålesund, Norway, 6003
        • Novo Nordisk Investigational Site
  • Portugal
      • Almada, Portugal, 2805-267
        • Novo Nordisk Investigational Site
      • Coimbra, Portugal, 3046-853
        • Novo Nordisk Investigational Site
      • Lisboa, Portugal, 1500-650
        • Novo Nordisk Investigational Site
      • Lisboa, Portugal, 1250-230
        • Novo Nordisk Investigational Site
      • Matosinhos, Portugal, 4464-513
        • Novo Nordisk Investigational Site
      • Tomar, Portugal, 2304-909
        • Novo Nordisk Investigational Site
      • Viana do Castelo, Portugal, 4901-858
        • Novo Nordisk Investigational Site
      • Vila Nova de Gaia, Portugal, 4434-502
        • Novo Nordisk Investigational Site
  • Romania
      • Brasov, Romania, 500365
        • Novo Nordisk Investigational Site
      • Bucharest, Romania, 020359
        • Novo Nordisk Investigational Site
      • Bucharest, Romania, 022441
        • Novo Nordisk Investigational Site
    • Maramures
      • Baia Mare, Maramures, Romania, 430123
        • Novo Nordisk Investigational Site
    • Prahova
      • Ploiesti, Prahova, Romania, 100342
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Barnaul, Russian Federation, 656024
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 119435
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 117036
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 125367
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 115478
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation
        • Novo Nordisk Investigational Site
      • Nizhniy Novgorod, Russian Federation, 603011
        • Novo Nordisk Investigational Site
      • Novosibirsk, Russian Federation, 630099
        • Novo Nordisk Investigational Site
      • Novosibirsk, Russian Federation, 630047
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 197762
        • Novo Nordisk Investigational Site
      • Samara, Russian Federation, 443041
        • Novo Nordisk Investigational Site
      • Saratov, Russian Federation, 410018
        • Novo Nordisk Investigational Site
      • Smolensk, Russian Federation, 214019
        • Novo Nordisk Investigational Site
      • Tomsk, Russian Federation, 634063
        • Novo Nordisk Investigational Site
      • Tumen, Russian Federation, 625023
        • Novo Nordisk Investigational Site
      • Ufa, Russian Federation, 450083
        • Novo Nordisk Investigational Site
      • Volgograd, Russian Federation, 400138
        • Novo Nordisk Investigational Site
      • Voronezh, Russian Federation, 394018
        • Novo Nordisk Investigational Site
      • Yaroslavl, Russian Federation, 150003
        • Novo Nordisk Investigational Site
  • South Africa
    • Eastern Cape
      • East London, Eastern Cape, South Africa, 5201
        • Novo Nordisk Investigational Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2001
        • Novo Nordisk Investigational Site
      • Krugersdorp, Gauteng, South Africa, 1739
        • Novo Nordisk Investigational Site
      • Pretoria, Gauteng, South Africa, 0002
        • Novo Nordisk Investigational Site
      • Pretoria, Gauteng, South Africa, 0084
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Novo Nordisk Investigational Site
      • Durban, KwaZulu-Natal, South Africa, 4092
        • Novo Nordisk Investigational Site
  • Spain
      • Almería, Spain, 04001
        • Novo Nordisk Investigational Site
      • Centelles (Barcelona), Spain, 08540
        • Novo Nordisk Investigational Site
      • La Coruña, Spain, 15006
        • Novo Nordisk Investigational Site
      • La Roca del Vallés, Spain, 08430
        • Novo Nordisk Investigational Site
      • Lleida, Spain, 25198
        • Novo Nordisk Investigational Site
      • Palma de Mallorca, Spain, 07010
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41003
        • Novo Nordisk Investigational Site
  • Sweden
      • Kristianstad, Sweden, 291 85
        • Novo Nordisk Investigational Site
      • Lund, Sweden, 222 22
        • Novo Nordisk Investigational Site
      • Malmö, Sweden, 205 02
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 113 24
        • Novo Nordisk Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Novo Nordisk Investigational Site
      • Bangkok, Thailand, 10330
        • Novo Nordisk Investigational Site
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Novo Nordisk Investigational Site
      • Nakhon Ratchasima, Thailand, 30000
        • Novo Nordisk Investigational Site
  • Turkey
      • Ankara, Turkey, 06110
        • Novo Nordisk Investigational Site
      • Antalya, Turkey, 07058
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34722
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34303
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34718
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34752
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34371
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34890
        • Novo Nordisk Investigational Site
      • Konya, Turkey, 42090
        • Novo Nordisk Investigational Site
      • Rize, Turkey, 53020
        • Novo Nordisk Investigational Site
      • Trabzon, Turkey, 61040
        • Novo Nordisk Investigational Site
      • Çorum, Turkey, 19200
        • Novo Nordisk Investigational Site
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Novo Nordisk Investigational Site
      • Ivano-Frankivsk, Ukraine, 76018
        • Novo Nordisk Investigational Site
      • Kyiv, Ukraine, 04114
        • Novo Nordisk Investigational Site
      • Odesa, Ukraine, 65114
        • Novo Nordisk Investigational Site
      • Vinnytsia, Ukraine, 21010
        • Novo Nordisk Investigational Site
      • Zaporizhia, Ukraine, 69600
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.
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 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.
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 1.0 mg
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.
Drug: sitagliptin
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 0.5 mg
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.
Drug: sitagliptin
Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0, week 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0, week 56
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.
Week 0, week 56
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
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
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.
Week 0, week 56
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.
After 56 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2013

Primary Completion (Actual)

October 12, 2015

Study Completion (Actual)

October 12, 2015

Study Registration Dates

First Submitted

August 23, 2013

First Submitted That Met QC Criteria

August 23, 2013

First Posted (Estimate)

August 28, 2013

Study Record Updates

Last Update Posted (Actual)

June 13, 2019

Last Update Submitted That Met QC Criteria

May 28, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

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))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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