Clinical Trial Details
| Trial ID: | L5795 |
| Source ID: | NCT02453685 |
| Associated Drug: | Biphasic Insulin Aspart 30 |
| Title: | A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02453685/results |
| Conditions: | Diabetes|Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: biphasic insulin aspart 30|DRUG: insulin glargine|DRUG: insulin aspart |
| Outcome Measures: | Primary: Change in HbA1c (Glycosylated Haemoglobin), Change in HbA1c from baseline (week 0) to week 32., Week 0, week 32 | Secondary: HbA1c Below 7.0% Without Severe Hypoglycaemic Episodes, Percentage of subjects with HbA1c below 7.0% after 32 weeks of randomised treatment without treatment emergent severe hypoglycaemic episodes during the last 12 weeks of treatment. Subjects withdrawn before 32 weeks were handled as non-responders. Severe hypoglycaemic episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration., After 32 weeks of treatment (yes/no)|Number of Treatment Emergent Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) and the Novo Nordisk Definitions, Hypoglycaemic episodes were classified as severe, Asymptomatic, Documented symptomatic, Pseudo, and Probable symptomatic as per ADA classification. As symptoms of hypoglycaemia occur below a PG level of 3.1 mmol/L, (56 mg/dL) Novo Nordisk classification included hypoglycaemia with plasma glucose (PG) levels below 3.1 mmol/L (56 mg/dL) in the definition of blood glucose confirmed hypoglycaemia. Hence, Novo Nordisk classification included following types of hypoglycaemia in addition to ADA classification: Severe hypoglycaemia, Symptomatic blood glucose confirmed hypoglycaemia, Asymptomatic blood glucose confirmed hypoglycaemia, Severe or blood glucose confirmed symptomatic hypoglycaemia, Blood glucose confirmed hypoglycaemia, and Severe or blood glucose confirmed hypoglycaemia. Reported data represents total of all hypoglycaemic episodes., Weeks 0-32|Total Daily Insulin Dose, Total daily insulin dose in the basal bolus treatment group and in BIAsp 30 treatment group at each week of each treatment., Weeks 0-32 |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 335 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2015-08-31 |
| Completion Date: | 2016-09-20 |
| Results First Posted: | 2019-02-08 |
| Last Update Posted: | 2019-02-08 |
| Locations: | 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, Ipswich, Queensland, 4305, Australia|Novo Nordisk Investigational Site, Fitzroy, Victoria, 3065, Australia|Novo Nordisk Investigational Site, Melbourne, Victoria, 3004, Australia|Novo Nordisk Investigational Site, Petrich, 2850, Bulgaria|Novo Nordisk Investigational Site, Sliven, 8800, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1202, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1431, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1606, Bulgaria|Novo Nordisk Investigational Site, Budapest, 1032, Hungary|Novo Nordisk Investigational Site, Budapest, 1042, Hungary|Novo Nordisk Investigational Site, Nyíregyhaza, 4400, Hungary|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500003, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560060, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400008, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400058, India|Novo Nordisk Investigational Site, Madurai, Tamil Nadu, 625 020, India|Novo Nordisk Investigational Site, Vellore, Tamil Nadu, 632004, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700032, India|Novo Nordisk Investigational Site, New Delhi, 110001, India|Novo Nordisk Investigational Site, Seoul, 02447, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 03722, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 135710, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 138-736, Korea, Republic of|Novo Nordisk Investigational Site, Belgrade, 11000, Serbia|Novo Nordisk Investigational Site, Belgrade, 11080, Serbia|Novo Nordisk Investigational Site, Nis, 18000, Serbia|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, Khon Kaen, 40002, Thailand|Novo Nordisk Investigational Site, Antalya, 07058, Turkey|Novo Nordisk Investigational Site, Istanbul, 34303, Turkey|Novo Nordisk Investigational Site, Istanbul, 34752, Turkey|Novo Nordisk Investigational Site, Malatya, 44280, Turkey|Novo Nordisk Investigational Site, Rize, 53020, Turkey|Novo Nordisk Investigational Site, Ajman, 21499, United Arab Emirates|Novo Nordisk Investigational Site, Dubai, 22241, United Arab Emirates|Novo Nordisk Investigational Site, Ras Al Khaimah, 4727, United Arab Emirates|Novo Nordisk Investigational Site, Umm Al Quwain, 24, United Arab Emirates |
| URL: | https://clinicaltrials.gov/show/NCT02453685 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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