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Clinical Trial Details

Trial ID: L2990
Source ID: NCT01849289
Associated Drug: Insulin Degludec
Title: A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes
Acronym: BEGIN™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01849289/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin Degludec|DRUG: Insulin Glargine
Outcome Measures: Primary: Change From Baseline in HbA1c (%) (Analysed by Central Laboratory), Change from baseline in HbA1c (%) after 26 weeks of treatment., Week 0, week 26 | Secondary: Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes, Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed PG value of less than 3.1 mmol/L (56 mg/dL).Minor hypoglycaemic episode is defined as an episode with symptoms consistent with hypoglycaemia with confirmation by full blood glucose \< 2.8 mmol/L (50 mg/dL), or PG \< 3.1 mmol/L (56 mg/dL) and which is handled by the subject himself/herself or any asymptomatic full blood glucose value \< 2.8 mmol/L (50 mg/dL) or PG value \< 3.1 mmol/L (56 mg/dL)., On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)|Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory), Change from baseline in FPG after 26 weeks of treatment., Week 0, week 26|Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose), Within subject Coefficient of variation(CV\[%\]) in pre-breakfast self measured plasma glucose for dose adjustment after 26 treatment weeks are displayed below., Week 26|Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes, A responder for HbA1c without severe or confirmed hypoglycaemia is defined as a subject, who meets the HbA1c target at end of trial without treatment emergent severe or confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days from last treatment., Week 26|Number of Treatment Emergent AEs (Adverse Events), Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration), On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 833
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-06-02
Completion Date: 2014-05-15
Results First Posted: 2016-01-14
Last Update Posted: 2017-04-07
Locations: Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, Lomita, California, 90717, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, Golden, Colorado, 80401, United States|Novo Nordisk Investigational Site, Clearwater, Florida, 33765, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60607, United States|Novo Nordisk Investigational Site, Crestview Hills, Kentucky, 41017-3464, United States|Novo Nordisk Investigational Site, Metairie, Louisiana, 70002, United States|Novo Nordisk Investigational Site, Troy, Michigan, 48098, United States|Novo Nordisk Investigational Site, Chesterfield, Missouri, 63017, United States|Novo Nordisk Investigational Site, Nashua, New Hampshire, 03063, United States|Novo Nordisk Investigational Site, Toms River, New Jersey, 08755-8050, United States|Novo Nordisk Investigational Site, Smithtown, New York, 11787, United States|Novo Nordisk Investigational Site, Simpsonville, South Carolina, 29681, United States|Novo Nordisk Investigational Site, Jackson, Tennessee, 38305, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Newport News, Virginia, 23606, United States|Novo Nordisk Investigational Site, Kenosha, Wisconsin, 53142, United States|Novo Nordisk Investigational Site, São Paulo, Sao Paulo, 01244-030, Brazil|Novo Nordisk Investigational Site, Porto Alegre, 90035-170, Brazil|Novo Nordisk Investigational Site, São Paulo, 04022-002, Brazil|Novo Nordisk Investigational Site, Calgary, Alberta, T2N 4L7, Canada|Novo Nordisk Investigational Site, Burnaby, British Columbia, V5G 1T4, Canada|Novo Nordisk Investigational Site, Surrey, British Columbia, V3S 2N6, Canada|Novo Nordisk Investigational Site, Victoria, British Columbia, V8V 4A1, Canada|Novo Nordisk Investigational Site, Burlington, Ontario, L7M 4Y1, Canada|Novo Nordisk Investigational Site, London, Ontario, N5W 6A2, Canada|Novo Nordisk Investigational Site, London, Ontario, N6P 1A9, Canada|Novo Nordisk Investigational Site, Newmarket, Ontario, L3Y 5G8, Canada|Novo Nordisk Investigational Site, Sarnia, Ontario, N7T 4X3, Canada|Novo Nordisk Investigational Site, Strathroy, Ontario, N7G 1Y7, Canada|Novo Nordisk Investigational Site, Trois Rivieres, Quebec, G8T7A1, Canada|Novo Nordisk Investigational Site, Quebec, G3K 2P8, Canada|Novo Nordisk Investigational Site, Hefei, Anhui, 230001, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100029, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100039, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100191, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100700, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100730, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100853, China|Novo Nordisk Investigational Site, Chongqing, Chongqing, 400010, China|Novo Nordisk Investigational Site, Chongqing, Chongqing, 400016, China|Novo Nordisk Investigational Site, ChongQing, Chongqing, 404000, China|Novo Nordisk Investigational Site, Fuzhou, Fujian, 350025, China|Novo Nordisk Investigational Site, Guangzhou, Guangdong, 510120, China|Novo Nordisk Investigational Site, Nanning, Guangxi, 530007, China|Novo Nordisk Investigational Site, Guiyang, Guizhou, 550004, China|Novo Nordisk Investigational Site, Shijiazhuang, Hebei, 050051, China|Novo Nordisk Investigational Site, Shijiazhuang, Hebei, 050082, China|Novo Nordisk Investigational Site, Harbin, Heilongjiang, 150086, China|Novo Nordisk Investigational Site, Wuhan, Hubei, 430030, China|Novo Nordisk Investigational Site, Wuhan, Hubei, 430034, China|Novo Nordisk Investigational Site, Yueyang, Hunan, 414000, China|Novo Nordisk Investigational Site, Yangzhou, Jiangsu, 225001, China|Novo Nordisk Investigational Site, Zhenjiang, Jiangsu, 212001, China|Novo Nordisk Investigational Site, Nanchang, Jiangxi, 330006, China|Novo Nordisk Investigational Site, Changchun, Jilin, 130041, China|Novo Nordisk Investigational Site, Siping, Jilin, 136000, China|Novo Nordisk Investigational Site, Shenyang, Liaoning, 110004, China|Novo Nordisk Investigational Site, Shenyang, Liaoning, 110021, China|Novo Nordisk Investigational Site, Xi'an, Shaanxi, 710032, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200040, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200072, China|Novo Nordisk Investigational Site, Kunming, Yunnan, 650101, China|Novo Nordisk Investigational Site, Hangzhou, Zhejiang, 310003, China|Novo Nordisk Investigational Site, Wenzhou, Zhejiang, 325000, China|Novo Nordisk Investigational Site, Oradea, Bihor, 410469, Romania|Novo Nordisk Investigational Site, Bucharest, 020614, Romania|Novo Nordisk Investigational Site, Buzau, 120203, Romania|Novo Nordisk Investigational Site, Galati, 800578, Romania|Novo Nordisk Investigational Site, Sibiu, 550176, Romania|Novo Nordisk Investigational Site, George, Eastern Cape, 6529, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1812, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 2193, 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, Dnepropetrovsk, 49005, Ukraine|Novo Nordisk Investigational Site, Dnepropetrovsk, 49038, Ukraine|Novo Nordisk Investigational Site, Kiev, 04114, Ukraine|Novo Nordisk Investigational Site, Mykolaiv, 54003, Ukraine|Novo Nordisk Investigational Site, Vinnitsa, 21010, Ukraine
URL: https://clinicaltrials.gov/show/NCT01849289

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress