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Clinical Trial Details

Trial ID: L5449
Source ID: NCT01059799
Associated Drug: Insulin Degludec
Title: Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes
Acronym: BEGIN™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01059799/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: 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: Rate of Confirmed Hypoglycaemic Episodes, Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure 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|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
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 435
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-02-01
Completion Date: 2010-12-16
Results First Posted: 2015-11-13
Last Update Posted: 2017-03-30
Locations: Novo Nordisk Investigational Site, Shatin, New Territories, Hong Kong|Novo Nordisk Investigational Site, Chuo-ku, Tokyo, 103 0002, Japan|Novo Nordisk Investigational Site, Kamakura-shi, Kanagawa, 247 0072, Japan|Novo Nordisk Investigational Site, Kawasaki-shi, 212 0024, Japan|Novo Nordisk Investigational Site, Miyazaki-shi, 880 0034, Japan|Novo Nordisk Investigational Site, Naka-shi, Ibaraki, 311 0113, Japan|Novo Nordisk Investigational Site, Nishinomiya-shi, Hygo, 662 0971, Japan|Novo Nordisk Investigational Site, Ogawa-machi, 355 0321, Japan|Novo Nordisk Investigational Site, Oita-shi, 870 0039, Japan|Novo Nordisk Investigational Site, Ota-ku, Tokyo, 144 0035, Japan|Novo Nordisk Investigational Site, Oyama-shi, Tochigi, 323 0022, Japan|Novo Nordisk Investigational Site, Sapporo-shi, Hokkaido, 060-0001, Japan|Novo Nordisk Investigational Site, Takatsuki-shi, Osaka, 569 1096, Japan|Novo Nordisk Investigational Site, Bucheon, 14647, Korea, Republic of|Novo Nordisk Investigational Site, Busan, 614-735, Korea, Republic of|Novo Nordisk Investigational Site, Goyang, 10380, Korea, Republic of|Novo Nordisk Investigational Site, Goyang, 410-719, Korea, Republic of|Novo Nordisk Investigational Site, Incheon, 400-103, Korea, Republic of|Novo Nordisk Investigational Site, Jeonju, 561-712, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 110-746, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 120-752, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 130-701, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 133-792, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 135-239, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 135-720, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 139-827, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 150-950, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 158-710, Korea, Republic of|Novo Nordisk Investigational Site, Suwon, 16247, Korea, Republic of|Novo Nordisk Investigational Site, Suwon, 16499, Korea, Republic of|Novo Nordisk Investigational Site, Wonju, 220-701, Korea, Republic of|Novo Nordisk Investigational Site, Yangsan, 626-770, Korea, Republic of|Novo Nordisk Investigational Site, Cheras, 56000, Malaysia|Novo Nordisk Investigational Site, Georgetown, Penang, 10450, Malaysia|Novo Nordisk Investigational Site, Kota Bharu, Kelantan, 16150, Malaysia|Novo Nordisk Investigational Site, Kuala Lumpur, 50586, 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, Selangor, 46150, Malaysia|Novo Nordisk Investigational Site, Changhua, 500, Taiwan|Novo Nordisk Investigational Site, Chiayi City, 600, Taiwan|Novo Nordisk Investigational Site, Kaohsiung, 813, Taiwan|Novo Nordisk Investigational Site, Kaoshiung, 807, Taiwan|Novo Nordisk Investigational Site, Pan-Chiao, 220, Taiwan|Novo Nordisk Investigational Site, Taichung, Taiwan|Novo Nordisk Investigational Site, Taipei, 104, Taiwan|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, Chiang Mai, 50200, Thailand|Novo Nordisk Investigational Site, Nakhon Ratchasima, 30000, Thailand|Novo Nordisk Investigational Site, Songkla, 90110, Thailand
URL: https://clinicaltrials.gov/show/NCT01059799

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