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Clinical Trial Details

Trial ID: L3177
Source ID: NCT01519674
Associated Drug: Biphasic Insulin Aspart 30
Title: Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin
Acronym: SIT2MIX
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01519674/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: biphasic insulin aspart 30|DRUG: biphasic insulin aspart 30|DRUG: sitagliptin|DRUG: metformin
Outcome Measures: Primary: Change From Baseline in HbA1c (Glycosylated Haemoglobin), Estimated mean change from baseline in HbA1c after 24 weeks of treatment., Week 0 to Week 24 | Secondary: Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%), Proportion of subjects achieving HbA1c below 7.0% after 24 weeks of treatment, After 24 weeks of treatment|Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%), Proportion of subjects achieving HbA1c equal to or below 6.5% after 24 weeks of treatment., After 24 weeks of treatment|Change From Baseline in Fasting Plasma Glucose (FPG), Estimated mean change from baseline in fasting plasma glucose (FPG), Week 0 to Week 24|Prandial Plasma Glucose (PPG) Increments at Breakfast, Estimated mean post prandial increments at breakfast after 24 weeks of treatment., After 24 weeks of treatment|Prandial Plasma Glucose (PPG) Increments at Lunch., Estimated mean post prandial increments at lunch after 24 weeks of treatment., After 24 weeks of treatment|Prandial Plasma Glucose (PPG) Increments at Dinner., Estimated mean post prandial increments at dinner after 24 weeks of treatment., After 24 weeks of treatment|Prandial Plasma Glucose (PPG) Overall Mean Increment., Estimated overall mean post prandial increment after 24 weeks of treatment., After 24 weeks of treatment|Adverse Events (AEs), Rate of AEs per 100 years of patient exposure. An adverse event was defined as treatment emergent if the event had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment., Week 0 to Week 24|Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes., Number of treatment emergent hypoglycaemic episodes. Treatment emergent hypoglycaemic episode: if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Nocturnal: Time of onset between 00:01 and 05:59 a.m. (both included). Additional minor hypoglycaemic episode: symptomatic or asymptomatic hypoglycaemia with blood glucose (BG) values \< 2.8 mmol/L (50 mg/dL) or plasma glucose (PG) \< 3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself., Week 0 to Week 24|Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes., Estimated mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) 'total score' to end of trial. The score measured treatment satisfaction. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction., Week 0 to Week 24
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 582
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-06
Completion Date: 2013-10
Results First Posted: 2014-11-10
Last Update Posted: 2017-02-24
Locations: Novo Nordisk Investigational Site, Buenos Aires, B1704ETD, Argentina|Novo Nordisk Investigational Site, Buenos Aires, C1250AAN, Argentina|Novo Nordisk Investigational Site, Caba, C1179AAB, Argentina|Novo Nordisk Investigational Site, Caba, C1440AAD, Argentina|Novo Nordisk Investigational Site, Mar del Plata, B7600FZN, Argentina|Novo Nordisk Investigational Site, Morón, B1708IFF, Argentina|Novo Nordisk Investigational Site, Broadmeadow, New South Wales, 2292, Australia|Novo Nordisk Investigational Site, Coffs Harbour, New South Wales, 2450, Australia|Novo Nordisk Investigational Site, São Paulo, Sao Paulo, 01244-030, Brazil|Novo Nordisk Investigational Site, Brasília, 71625-009, Brazil|Novo Nordisk Investigational Site, Curitiba, 80810-040, Brazil|Novo Nordisk Investigational Site, Fortaleza, 60430-350, Brazil|Novo Nordisk Investigational Site, Porto Alegre, 90035-170, Brazil|Novo Nordisk Investigational Site, Alexandroupolis, GR-68100, Greece|Novo Nordisk Investigational Site, Athens, 151 23, Greece|Novo Nordisk Investigational Site, Athens, GR-17562, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-54642, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-57001, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-57010, Greece|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500003, India|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500034, India|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500082, India|Novo Nordisk Investigational Site, Visakhapatnam, Andhra Pradesh, 530002, India|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380006, India|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380016, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560 017, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560002, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560043, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560092, India|Novo Nordisk Investigational Site, Calicut, Kerala, 673016, India|Novo Nordisk Investigational Site, Trivandrum, Kerala, 695607, India|Novo Nordisk Investigational Site, Nagpur, Maharashtra, 440010, India|Novo Nordisk Investigational Site, Amritsar, Punjab, 143001, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600003, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600006, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600040, India|Novo Nordisk Investigational Site, Coimbatore, Tamil Nadu, 641009, India|Novo Nordisk Investigational Site, Trichy, Tamil Nadu, 620018, India|Novo Nordisk Investigational Site, Kanpur, Uttar Pradesh, 208005, India|Novo Nordisk Investigational Site, Noida, Uttar Pradesh, 201301, India|Novo Nordisk Investigational Site, Varanasi, Uttar Pradesh, 221105, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700019, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700038, India|Novo Nordisk Investigational Site, New Delhi, 110001, India|Novo Nordisk Investigational Site, Goyang, 10380, Korea, Republic of|Novo Nordisk Investigational Site, Jeonju, 561-712, Korea, Republic of|Novo Nordisk Investigational Site, Pusan, 602-739, Korea, Republic of|Novo Nordisk Investigational Site, Pyungchon-Dong 896, Dongan-Gu, 431-796, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 03080, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 150-713, Korea, Republic of|Novo Nordisk Investigational Site, Suwon, 16247, Korea, Republic of|Novo Nordisk Investigational Site, Ulsan, 682-060, Korea, Republic of|Novo Nordisk Investigational Site, Penang, 10459, Malaysia|Novo Nordisk Investigational Site, Seremban, 70300, Malaysia|Novo Nordisk Investigational Site, Coimbra, 3000-561, Portugal|Novo Nordisk Investigational Site, Lisboa, 1250-230, Portugal|Novo Nordisk Investigational Site, Lisboa, 1500-650, Portugal|Novo Nordisk Investigational Site, Lisboa, 1649-035, Portugal|Novo Nordisk Investigational Site, Matosinhos, 4464-513, Portugal|Novo Nordisk Investigational Site, Porto, 4200-319, Portugal|Novo Nordisk Investigational Site, Bangkok, 10330, Thailand|Novo Nordisk Investigational Site, Bangkok, 10400, Thailand|Novo Nordisk Investigational Site, Chiang Mai, 50200, Thailand|Novo Nordisk Investigational Site, Khon Kaen, 40002, Thailand|Novo Nordisk Investigational Site, Antalya, 07058, 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, 34890, Turkey
URL: https://clinicaltrials.gov/show/NCT01519674

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details