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Clinical Trial Details

Trial ID: L2017
Source ID: NCT01006291
Associated Drug: Insulin Degludec
Title: Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes
Acronym: BEGIN™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01006291/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec|DRUG: insulin degludec|DRUG: insulin glargine
Outcome Measures: Primary: Change in Glycosylated Haemoglobin (HbA1c), Change from baseline in HbA1c after 26 weeks of treatment, Week 0, Week 26 | Secondary: Mean of 9-point Self Measured Plasma Glucose Profile (SMPG), Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, before bedtime, at 4 am and before breakfast., Week 26|Rate of Confirmed Hypoglycaemic Episodes, Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L., Week 0 to Week 26 + 7 days follow up|Rate of Nocturnal Confirmed Hypoglycaemic Episodes, Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m., Week 0 to Week 26 + 7 days follow up
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 687
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-11
Completion Date: 2010-09
Results First Posted: 2015-11-13
Last Update Posted: 2017-02-09
Locations: Novo Nordisk Investigational Site, Buenos Aires, B1636DSU, Argentina|Novo Nordisk Investigational Site, Buenos Aires, C1425AGC, Argentina|Novo Nordisk Investigational Site, Ciudad Autónoma de Bs As, C1426ABP, Argentina|Novo Nordisk Investigational Site, Rosario, 2000, Argentina|Novo Nordisk Investigational Site, Hanko, 10900, Finland|Novo Nordisk Investigational Site, Harjavalta, FI-29200, Finland|Novo Nordisk Investigational Site, Oulu, 90029, Finland|Novo Nordisk Investigational Site, Tampere, FI-33520, Finland|Novo Nordisk Investigational Site, Turku, 20520, Finland|Novo Nordisk Investigational Site, Turku, FI-20100, Finland|Novo Nordisk Investigational Site, Vantaa, FIN-01600, Finland|Novo Nordisk Investigational Site, Budapest, 1041, Hungary|Novo Nordisk Investigational Site, Debrecen, 4043, Hungary|Novo Nordisk Investigational Site, Gyor, 9024, Hungary|Novo Nordisk Investigational Site, Szombathely, H-9700, Hungary|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500082, India|Novo Nordisk Investigational Site, Kochi, Kerala, 682041, India|Novo Nordisk Investigational Site, Indore, Madhya Pradesh, 452010, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400012, India|Novo Nordisk Investigational Site, New Dehli, New Delhi, 110029, India|Novo Nordisk Investigational Site, Chandigarh, Punjab, 160012, India|Novo Nordisk Investigational Site, Vellore, Tamil Nadu, 632004, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700020, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700038, India|Novo Nordisk Investigational Site, Chennai, 600020, India|Novo Nordisk Investigational Site, Hyderabad, 600034, India|Novo Nordisk Investigational Site, Beer Sheva, 84101, Israel|Novo Nordisk Investigational Site, Haifa, 31096, Israel|Novo Nordisk Investigational Site, Holon, 58100, Israel|Novo Nordisk Investigational Site, Jerusalem, 91120, Israel|Novo Nordisk Investigational Site, Kfar Saba, 44281, Israel|Novo Nordisk Investigational Site, Netanya, 42449, Israel|Novo Nordisk Investigational Site, Petah-Tikva, 49100, Israel|Novo Nordisk Investigational Site, Rehovot, 76100, Israel|Novo Nordisk Investigational Site, Skopje, 1000, Macedonia, The Former Yugoslav Republic of|Novo Nordisk Investigational Site, Cheras, 56000, Malaysia|Novo Nordisk Investigational Site, Kota Bharu, Kelantan, 16150, Malaysia|Novo Nordisk Investigational Site, Kuala Lumpur, 59100, Malaysia|Novo Nordisk Investigational Site, Penang, 10459, Malaysia|Novo Nordisk Investigational Site, Putrajaya, 62250, Malaysia|Novo Nordisk Investigational Site, Mexico City, México, D.F., 03300, Mexico|Novo Nordisk Investigational Site, Durango, 34000, Mexico|Novo Nordisk Investigational Site, Monterrey, 64460, Mexico|Novo Nordisk Investigational Site, Gjøvik, NO-2819, Norway|Novo Nordisk Investigational Site, Hamar, 2317, Norway|Novo Nordisk Investigational Site, Hønefoss, 3511, Norway|Novo Nordisk Investigational Site, Oslo, 0586, Norway|Novo Nordisk Investigational Site, Stavanger, 4005, Norway|Novo Nordisk Investigational Site, Tønsberg, 3116, Norway|Novo Nordisk Investigational Site, Kazan, 420064, Russian Federation|Novo Nordisk Investigational Site, Moscow, 117036, Russian Federation|Novo Nordisk Investigational Site, Moscow, 119435, Russian Federation|Novo Nordisk Investigational Site, Moscow, 121356, Russian Federation|Novo Nordisk Investigational Site, Moscow, 127644, Russian Federation|Novo Nordisk Investigational Site, Saint-Peterburg, 190068, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 195257, Russian Federation|Novo Nordisk Investigational Site, Belgrade, 11000, Serbia|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1829, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 2001, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4126, South Africa|Novo Nordisk Investigational Site, Taipei, 100, Taiwan|Novo Nordisk Investigational Site, Taipei, 112, Taiwan|Novo Nordisk Investigational Site, Taipei, 114, Taiwan|Novo Nordisk Investigational Site, Taoyuan, 333, Taiwan|Novo Nordisk Investigational Site, Belfast, BT16 1RH, United Kingdom|Novo Nordisk Investigational Site, Edgbaston, Birmingham, B15 2TH, United Kingdom|Novo Nordisk Investigational Site, Edinburgh, EH4 2XU, United Kingdom|Novo Nordisk Investigational Site, Glasgow, G45 9AW, United Kingdom|Novo Nordisk Investigational Site, Hull, HU3 2JZ, United Kingdom|Novo Nordisk Investigational Site, Ipswich, IP4 5PD, United Kingdom|Novo Nordisk Investigational Site, Londonderry, BT47 6SB, United Kingdom|Novo Nordisk Investigational Site, Swansea, SA6 6NL, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01006291

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress