Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6399
Source ID: NCT01930188
Associated Drug: Semaglutide
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
Acronym: SUSTAIN™ 2
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01930188/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: semaglutide|DRUG: sitagliptin|DRUG: placebo|DRUG: placebo
Outcome Measures: Primary: Change in HbA1c (Glycosylated Haemoglobin) From Baseline, 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: Change in Body Weight From Baseline, 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, 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, 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, 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), 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
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1231
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-12-02
Completion Date: 2015-10-12
Results First Posted: 2019-01-07
Last Update Posted: 2019-06-13
Locations: Novo Nordisk Investigational Site, Buenos Aires, C1425AGC, Argentina|Novo Nordisk Investigational Site, Caba, C1179AAB, Argentina|Novo Nordisk Investigational Site, Caba, Argentina|Novo Nordisk Investigational Site, Mar del Plata, B7600GNY, Argentina|Novo Nordisk Investigational Site, Burgas, 8000, Bulgaria|Novo Nordisk Investigational Site, Haskovo, 6300, Bulgaria|Novo Nordisk Investigational Site, Petrich, 2850, Bulgaria|Novo Nordisk Investigational Site, Ruse, 7000, Bulgaria|Novo Nordisk Investigational Site, Sliven, 8800, Bulgaria|Novo Nordisk Investigational Site, Smolyan, 4700, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1233, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1336, Bulgaria|Novo Nordisk Investigational Site, Stara Zagora, 6000, Bulgaria|Novo Nordisk Investigational Site, Vratsa, 3001, Bulgaria|Novo Nordisk Investigational Site, Chrudim, 537 01, Czechia|Novo Nordisk Investigational Site, Ostrava, 707 02, Czechia|Novo Nordisk Investigational Site, Plzen, 304 60, Czechia|Novo Nordisk Investigational Site, Praha 4- Chodov, 149 00, Czechia|Novo Nordisk Investigational Site, Praha 5, 150 00, Czechia|Novo Nordisk Investigational Site, Shatin, New Territories, Hong Kong|Novo Nordisk Investigational Site, Budapest, 1076, Hungary|Novo Nordisk Investigational Site, Budapest, H-1134, Hungary|Novo Nordisk Investigational Site, Debrecen, 4043, Hungary|Novo Nordisk Investigational Site, Szeged, H-6720, Hungary|Novo Nordisk Investigational Site, Szombathely, H-9700, Hungary|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500003, India|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380006, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560034, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560054, India|Novo Nordisk Investigational Site, Kochi, Kerala, 682041, India|Novo Nordisk Investigational Site, Kozhikode, Kerala, 673017, India|Novo Nordisk Investigational Site, Trivandrum, Kerala, 695011, India|Novo Nordisk Investigational Site, Indore, Madhya Pradesh, 452010, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400008, India|Novo Nordisk Investigational Site, Pune, Maharashtra, 411001, India|Novo Nordisk Investigational Site, Pune, Maharashtra, 411004, India|Novo Nordisk Investigational Site, Pune, Maharashtra, 411040, India|Novo Nordisk Investigational Site, Bhubaneswar, Orissa, 751019, India|Novo Nordisk Investigational Site, Ludhiana, Punjab, 141001, India|Novo Nordisk Investigational Site, Jaipur, Rajasthan, 302004, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600116, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700020, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700054, India|Novo Nordisk Investigational Site, New Delhi, 110017, India|Novo Nordisk Investigational Site, Asahikawa-shi, Hokkaido, 070-0002, Japan|Novo Nordisk Investigational Site, Ibaraki, 311-0113, Japan|Novo Nordisk Investigational Site, Kashiwara-shi, Osaka, 582-0005, Japan|Novo Nordisk Investigational Site, Kitakyushu-shi, Fukuoka, 800 0252, Japan|Novo Nordisk Investigational Site, Mitaka-shi, Tokyo, 181-0013, Japan|Novo Nordisk Investigational Site, Mito-shi, Ibaraki, 310-0826, Japan|Novo Nordisk Investigational Site, Miyazaki, 880-0034, Japan|Novo Nordisk Investigational Site, Okayama-shi, Okayama, 700 8505, Japan|Novo Nordisk Investigational Site, Osaka-shi, Osaka, 532 0003, Japan|Novo Nordisk Investigational Site, Osaka-shi, Osaka, Japan|Novo Nordisk Investigational Site, Osaka, 569-1045, Japan|Novo Nordisk Investigational Site, Sapporo-shi, Hokkaido, 060-0001, Japan|Novo Nordisk Investigational Site, Tokyo, 103-0027, Japan|Novo Nordisk Investigational Site, Tokyo, 125-0054, Japan|Novo Nordisk Investigational Site, Pachuca, Hidalgo, 42084, Mexico|Novo Nordisk Investigational Site, Guadalajara, Jalisco, 44670, Mexico|Novo Nordisk Investigational Site, Monterrey, Nuevo León, 64620, Mexico|Novo Nordisk Investigational Site, Aguascalientes, 20129, Mexico|Novo Nordisk Investigational Site, Aguascalientes, 20230, Mexico|Novo Nordisk Investigational Site, Hamar, 2317, Norway|Novo Nordisk Investigational Site, Kløfta, 2040, Norway|Novo Nordisk Investigational Site, Kongsvinger, 2212, Norway|Novo Nordisk Investigational Site, Stavanger, 4005, Norway|Novo Nordisk Investigational Site, Ålesund, 6003, Norway|Novo Nordisk Investigational Site, Almada, 2805-267, Portugal|Novo Nordisk Investigational Site, Coimbra, 3046-853, Portugal|Novo Nordisk Investigational Site, Lisboa, 1250-230, Portugal|Novo Nordisk Investigational Site, Lisboa, 1500-650, Portugal|Novo Nordisk Investigational Site, Matosinhos, 4464-513, Portugal|Novo Nordisk Investigational Site, Tomar, 2304-909, Portugal|Novo Nordisk Investigational Site, Viana do Castelo, 4901-858, Portugal|Novo Nordisk Investigational Site, Vila Nova de Gaia, 4434-502, Portugal|Novo Nordisk Investigational Site, Baia Mare, Maramures, 430123, Romania|Novo Nordisk Investigational Site, Ploiesti, Prahova, 100342, Romania|Novo Nordisk Investigational Site, Brasov, 500365, Romania|Novo Nordisk Investigational Site, Bucharest, 020359, Romania|Novo Nordisk Investigational Site, Bucharest, 022441, Romania|Novo Nordisk Investigational Site, Barnaul, 656024, Russian Federation|Novo Nordisk Investigational Site, Moscow, 115478, Russian Federation|Novo Nordisk Investigational Site, Moscow, 117036, Russian Federation|Novo Nordisk Investigational Site, Moscow, 119435, Russian Federation|Novo Nordisk Investigational Site, Moscow, 125367, Russian Federation|Novo Nordisk Investigational Site, Moscow, Russian Federation|Novo Nordisk Investigational Site, Nizhniy Novgorod, 603011, Russian Federation|Novo Nordisk Investigational Site, Novosibirsk, 630047, Russian Federation|Novo Nordisk Investigational Site, Novosibirsk, 630099, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 197762, Russian Federation|Novo Nordisk Investigational Site, Samara, 443041, Russian Federation|Novo Nordisk Investigational Site, Saratov, 410018, Russian Federation|Novo Nordisk Investigational Site, Smolensk, 214019, Russian Federation|Novo Nordisk Investigational Site, Tomsk, 634063, Russian Federation|Novo Nordisk Investigational Site, Tumen, 625023, Russian Federation|Novo Nordisk Investigational Site, Ufa, 450083, Russian Federation|Novo Nordisk Investigational Site, Volgograd, 400138, Russian Federation|Novo Nordisk Investigational Site, Voronezh, 394018, Russian Federation|Novo Nordisk Investigational Site, Yaroslavl, 150003, Russian Federation|Novo Nordisk Investigational Site, East London, Eastern Cape, 5201, South Africa|Novo Nordisk Investigational Site, Bloemfontein, Free State, 9301, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 2001, South Africa|Novo Nordisk Investigational Site, Krugersdorp, Gauteng, 1739, South Africa|Novo Nordisk Investigational Site, Pretoria, Gauteng, 0002, South Africa|Novo Nordisk Investigational Site, Pretoria, Gauteng, 0084, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4001, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4092, South Africa|Novo Nordisk Investigational Site, Almería, 04001, Spain|Novo Nordisk Investigational Site, Centelles (Barcelona), 08540, Spain|Novo Nordisk Investigational Site, La Coruña, 15006, Spain|Novo Nordisk Investigational Site, La Roca del Vallés, 08430, Spain|Novo Nordisk Investigational Site, Lleida, 25198, Spain|Novo Nordisk Investigational Site, Palma de Mallorca, 07010, Spain|Novo Nordisk Investigational Site, Sevilla, 41003, Spain|Novo Nordisk Investigational Site, Kristianstad, 291 85, Sweden|Novo Nordisk Investigational Site, Lund, 222 22, Sweden|Novo Nordisk Investigational Site, Malmö, 205 02, Sweden|Novo Nordisk Investigational Site, Stockholm, 113 24, Sweden|Novo Nordisk Investigational Site, Bangkoknoi, Bangkok, 10700, Thailand|Novo Nordisk Investigational Site, Bangkok, 10330, Thailand|Novo Nordisk Investigational Site, Bangkok, 10400, Thailand|Novo Nordisk Investigational Site, Nakhon Ratchasima, 30000, Thailand|Novo Nordisk Investigational Site, Ankara, 06110, Turkey|Novo Nordisk Investigational Site, Antalya, 07058, Turkey|Novo Nordisk Investigational Site, Istanbul, 34303, Turkey|Novo Nordisk Investigational Site, Istanbul, 34371, Turkey|Novo Nordisk Investigational Site, Istanbul, 34718, Turkey|Novo Nordisk Investigational Site, Istanbul, 34722, Turkey|Novo Nordisk Investigational Site, Istanbul, 34752, Turkey|Novo Nordisk Investigational Site, Istanbul, 34890, Turkey|Novo Nordisk Investigational Site, Konya, 42090, Turkey|Novo Nordisk Investigational Site, Rize, 53020, Turkey|Novo Nordisk Investigational Site, Trabzon, 61040, Turkey|Novo Nordisk Investigational Site, Çorum, 19200, Turkey|Novo Nordisk Investigational Site, Cherkasy, 18009, Ukraine|Novo Nordisk Investigational Site, Ivano-Frankivsk, 76018, Ukraine|Novo Nordisk Investigational Site, Kyiv, 04114, Ukraine|Novo Nordisk Investigational Site, Odesa, 65114, Ukraine|Novo Nordisk Investigational Site, Vinnytsia, 21010, Ukraine|Novo Nordisk Investigational Site, Zaporizhia, 69600, Ukraine
URL: https://clinicaltrials.gov/show/NCT01930188

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress