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Clinical Trial Details

Trial ID: L2660
Source ID: NCT00469092
Associated Drug: Biphasic Insulin Aspart
Title: Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00469092/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: biphasic insulin aspart|DRUG: insulin glargine|DRUG: metformin|DRUG: glimepiride
Outcome Measures: Primary: Glycosylated Haemoglobin A1c (HbA1c), Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment., After 26 weeks of treatment | Secondary: 9-point Self-measured Plasma Glucose Profiles, Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points for self-measurement during the day were: Before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL., After 26 weeks of treatment|Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c), The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c \<= 6.5% of haemoglobin and HbA1c \< 7% of haemoglobin., After 26 weeks of treatment|Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat), Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale., After 26 weeks of treatment|Number of Hypoglycaemic Episodes, Total number of hypoglycaemic episodes experienced in each treatment arm. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL., Weeks 0-26|Number of Subjects Reporting Treatment Emergent Adverse Events, Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration., Weeks 0-26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 480
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-05
Completion Date: 2008-04
Results First Posted: 2010-01-06
Last Update Posted: 2017-02-23
Locations: Novo Nordisk Investigational Site, Buenos Aires, C1181ACH, Argentina|Novo Nordisk Investigational Site, Ciudad Autonoma de Bs As, C1405CWB, Argentina|Novo Nordisk Investigational Site, Ciudad Autónoma de BsAs, C1406FWY, Argentina|Novo Nordisk Investigational Site, Mar del Plata, B7602CBM, Argentina|Novo Nordisk Investigational Site, Bregenz, A - 6900, Austria|Novo Nordisk Investigational Site, Feldkirch, 6807, Austria|Novo Nordisk Investigational Site, Traisen, 3160, Austria|Novo Nordisk Investigational Site, Wels, 4600, Austria|Novo Nordisk Investigational Site, Wien, 1100, Austria|Novo Nordisk Investigational Site, Brno, 656 91, Czech Republic|Novo Nordisk Investigational Site, Hradec Kralove, 500 05, Czech Republic|Novo Nordisk Investigational Site, Kragujevac, 34000, Former Serbia and Montenegro|Novo Nordisk Investigational Site, Nis, 18000, Former Serbia and Montenegro|Novo Nordisk Investigational Site, Novi Sad, 21000, Former Serbia and Montenegro|Novo Nordisk Investigational Site, LA ROCHELLE cedex, 17019, France|Novo Nordisk Investigational Site, Limoges, 87042, France|Novo Nordisk Investigational Site, Mougins, 06250, France|Novo Nordisk Investigational Site, Narbonne, 11108, France|Novo Nordisk Investigational Site, NEVERS cedex, 58033, France|Novo Nordisk Investigational Site, Pointe à Pitre, 97159, France|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380006, India|Novo Nordisk Investigational Site, Karnal, Haryana, 132001, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560043, India|Novo Nordisk Investigational Site, Visakhapatnam, 530001, India|Novo Nordisk Investigational Site, Cheras, 56000, Malaysia|Novo Nordisk Investigational Site, Kota Bharu, Kelantan, 16150, Malaysia|Novo Nordisk Investigational Site, Pulau Pinang, 10990, Malaysia|Novo Nordisk Investigational Site, Guadalajara, 44600, Mexico|Novo Nordisk Investigational Site, Guadalajara, 44620, Mexico|Novo Nordisk Investigational Site, Pachuca, 42060, Mexico|Novo Nordisk Investigational Site, Almere, 1311RL, Netherlands|Novo Nordisk Investigational Site, Groningen, 9711 SG, Netherlands|Novo Nordisk Investigational Site, Leiderdorp, 2352 RA, Netherlands|Novo Nordisk Investigational Site, Rotterdam, 3021 HC, Netherlands|Novo Nordisk Investigational Site, Zoetermeer, 2724 EK, Netherlands|Novo Nordisk Investigational Site, Manila, 1014, Philippines|Novo Nordisk Investigational Site, Quezon City, 1100, Philippines|Novo Nordisk Investigational Site, Quezon City, 1102, Philippines|Novo Nordisk Investigational Site, Bialystok, 15-276, Poland|Novo Nordisk Investigational Site, Bydgoszcz, 85-094, Poland|Novo Nordisk Investigational Site, Gdansk, 80-858, Poland|Novo Nordisk Investigational Site, Gdynia, 81-366, Poland|Novo Nordisk Investigational Site, Krakow, 31-501, Poland|Novo Nordisk Investigational Site, Lodz, 90-153, Poland|Novo Nordisk Investigational Site, Lubin, 59-301, Poland|Novo Nordisk Investigational Site, Lublin, 20-081, Poland|Novo Nordisk Investigational Site, Olsztyn, 10-561, Poland|Novo Nordisk Investigational Site, Poznan, 60-821, Poland|Novo Nordisk Investigational Site, Rzeszow, 35-301, Poland|Novo Nordisk Investigational Site, Szczecin, 71-455, Poland|Novo Nordisk Investigational Site, Warszawa, 02-507, Poland|Novo Nordisk Investigational Site, Zabrze, 41-800, Poland|Novo Nordisk Investigational Site, Botosani, 710224, Romania|Novo Nordisk Investigational Site, Bucharest, 020475, Romania|Novo Nordisk Investigational Site, Galati, 800371, Romania|Novo Nordisk Investigational Site, Satu Mare, 440055, Romania|Novo Nordisk Investigational Site, Targoviste, 130083, Romania|Novo Nordisk Investigational Site, Bloemfontein, Free State, 9301, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4001, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4091, South Africa|Novo Nordisk Investigational Site, Brits, North West, 0250, South Africa|Novo Nordisk Investigational Site, Alzira, 46600, Spain|Novo Nordisk Investigational Site, Madrid, 28040, Spain|Novo Nordisk Investigational Site, Madrid, 28041, Spain|Novo Nordisk Investigational Site, Málaga, 29009, Spain|Novo Nordisk Investigational Site, Göteborg, 413 45, Sweden|Novo Nordisk Investigational Site, Lund, 221 85, Sweden|Novo Nordisk Investigational Site, Malmö, 205 02, Sweden|Novo Nordisk Investigational Site, Stockholm, 182 88, Sweden
URL: https://clinicaltrials.gov/show/NCT00469092

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