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Trial record 1 of 2358 for:    SUSTAIN 2
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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01930188
First Posted: August 28, 2013
Last Update Posted: April 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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 Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: semaglutide Drug: sitagliptin Drug: placebo Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1231
Actual Study Start Date: December 2, 2013
Study Completion Date: October 12, 2015
Primary Completion Date: October 12, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


  Hide Study Locations
Locations
Argentina
Novo Nordisk Investigational Site
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
Bulgaria
Novo Nordisk Investigational Site
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
Czech Republic
Novo Nordisk Investigational Site
Chrudim, Czech Republic, 537 01
Novo Nordisk Investigational Site
Ostrava, Czech Republic, 707 02
Novo Nordisk Investigational Site
Plzen, Czech Republic, 304 60
Novo Nordisk Investigational Site
Praha 4- Chodov, Czech Republic, 149 00
Novo Nordisk Investigational Site
Praha 5, Czech Republic, 150 00
Hong Kong
Novo Nordisk Investigational Site
Shatin, New Territories, Hong Kong
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, 1076
Novo Nordisk Investigational Site
Budapest, Hungary, H-1134
Novo Nordisk Investigational Site
Debrecen, Hungary, 4043
Novo Nordisk Investigational Site
Szeged, Hungary, H-6720
Novo Nordisk Investigational Site
Szombathely, Hungary, H-9700
India
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India, 500003
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India, 380006
Novo Nordisk Investigational Site
Bangalore, Karnataka, India, 560034
Novo Nordisk Investigational Site
Bangalore, Karnataka, India, 560054
Novo Nordisk Investigational Site
Kochi, Kerala, India, 682041
Novo Nordisk Investigational Site
Kozhikode, Kerala, India, 673017
Novo Nordisk Investigational Site
Trivandrum, Kerala, India, 695011
Novo Nordisk Investigational Site
Indore, Madhya Pradesh, India, 452010
Novo Nordisk Investigational Site
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
Bhubaneswar, Orissa, India, 751019
Novo Nordisk Investigational Site
Ludhiana, Punjab, India, 141001
Novo Nordisk Investigational Site
Jaipur, Rajasthan, India, 302004
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India, 600116
Novo Nordisk Investigational Site
Kolkata, West Bengal, India, 700020
Novo Nordisk Investigational Site
Kolkata, West Bengal, India, 700054
Novo Nordisk Investigational Site
New Delhi, India, 110017
Japan
Novo Nordisk Investigational Site
Asahikawa-shi, Hokkaido, Japan, 070 0002
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 103 0027
Novo Nordisk Investigational Site
Kashiwara-shi, Osaka, Japan, 582 0005
Novo Nordisk Investigational Site
Katsushika-ku, Tokyo, Japan, 125 0054
Novo Nordisk Investigational Site
Kitakyushu-shi, Fukuoka, Japan, 800 0252
Novo Nordisk Investigational Site
Mito-shi, Ibaraki, Japan
Novo Nordisk Investigational Site
Miyazaki-shi, Japan, 880 0034
Novo Nordisk Investigational Site
Naka-shi, Ibaraki, Japan, 311 0113
Novo Nordisk Investigational Site
Okayama-shi, Okayama, Japan, 700 8505
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
Takatsuki-shi, Osaka, Japan, 569 1096
Novo Nordisk Investigational Site
Tokyo, Japan, 181-0013
Mexico
Novo Nordisk Investigational Site
Pachuca, Hidalgo, Mexico, 42084
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico, 44670
Novo Nordisk Investigational Site
Monterrey, Nuevo León, Mexico, 64620
Novo Nordisk Investigational Site
Aguascalientes, Mexico, 20129
Novo Nordisk Investigational Site
Aguascalientes, Mexico, 20230
Norway
Novo Nordisk Investigational Site
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
Portugal
Novo Nordisk Investigational Site
Almada, Portugal, 2805-267
Novo Nordisk Investigational Site
Coimbra, Portugal, 3046-853
Novo Nordisk Investigational Site
Lisboa, Portugal, 1250-230
Novo Nordisk Investigational Site
Lisboa, Portugal, 1500-650
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
Romania
Novo Nordisk Investigational Site
Baia Mare, Maramures, Romania, 430123
Novo Nordisk Investigational Site
Ploiesti, Prahova, Romania, 100342
Novo Nordisk Investigational Site
Brasov, Romania, 500365
Novo Nordisk Investigational Site
Bucharest, Romania, 020359
Novo Nordisk Investigational Site
Bucharest, Romania, 022441
Russian Federation
Novo Nordisk Investigational Site
Barnaul, Russian Federation, 656024
Novo Nordisk Investigational Site
Moscow, Russian Federation, 115478
Novo Nordisk Investigational Site
Moscow, Russian Federation, 117036
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119435
Novo Nordisk Investigational Site
Moscow, Russian Federation, 125367
Novo Nordisk Investigational Site
Moscow, Russian Federation
Novo Nordisk Investigational Site
Nizhniy Novgorod, Russian Federation, 603011
Novo Nordisk Investigational Site
Novosibirsk, Russian Federation, 630047
Novo Nordisk Investigational Site
Novosibirsk, Russian Federation, 630099
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
South Africa
Novo Nordisk Investigational Site
East London, Eastern Cape, South Africa, 5201
Novo Nordisk Investigational Site
Bloemfontein, Free State, South Africa, 9301
Novo Nordisk Investigational Site
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
Durban, KwaZulu-Natal, South Africa, 4001
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4092
Spain
Novo Nordisk Investigational Site
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
Sweden
Novo Nordisk Investigational Site
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
Thailand
Novo Nordisk Investigational Site
Bangkoknoi, Bangkok, Thailand, 10700
Novo Nordisk Investigational Site
Bangkok, Thailand, 10330
Novo Nordisk Investigational Site
Bangkok, Thailand, 10400
Novo Nordisk Investigational Site
Nakhon Ratchasima, Thailand, 30000
Turkey
Novo Nordisk Investigational Site
Ankara, Turkey, 06110
Novo Nordisk Investigational Site
Antalya, Turkey, 07058
Novo Nordisk Investigational Site
İstanbul, Turkey, 34303
Novo Nordisk Investigational Site
Istanbul, Turkey, 34371
Novo Nordisk Investigational Site
Istanbul, Turkey, 34718
Novo Nordisk Investigational Site
Istanbul, Turkey, 34722
Novo Nordisk Investigational Site
Istanbul, Turkey, 34752
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
Ukraine
Novo Nordisk Investigational Site
Cherkassy, Ukraine, 18009
Novo Nordisk Investigational Site
Ivano-frankivsk, Ukraine, 76018
Novo Nordisk Investigational Site
Kiev, Ukraine, 04114
Novo Nordisk Investigational Site
Odesa, Ukraine, 65114
Novo Nordisk Investigational Site
Vinnitsa, Ukraine, 21010
Novo Nordisk Investigational Site
Zaporozhye, Ukraine, 69600
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
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.

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 Submitted: August 23, 2013
First Posted: August 28, 2013
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