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Clinical Trial Details

Trial ID: L3604
Source ID: NCT01923181
Associated Drug: Semaglutide
Title: Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01923181/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: semaglutide|DRUG: semaglutide|DRUG: oral placebo
Outcome Measures: Primary: Change in HbA1c (Glycosylated Haemoglobin), Change from baseline (week 0) in HbA1c was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation., Week 0, week 26 | Secondary: Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol), Participants who achieved HbA1c \<7.0%, was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation., After 26 weeks of treatment|Change in Body Weight, Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation., Week 0, Week 26|Change in Waist Circumference, Change from baseline (week 0) in waist circumference was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation., Week 0, week 26|Change in Body Mass Index (BMI), Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation., Week 0, week 26|Number of Treatment Emergent Adverse Events (TEAEs) Recorded, TEAEs were recorded during weeks 0-31 (26 weeks treatment period+5 weeks follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication., Weeks 0-31|Number of Confirmed Hypoglycaemic Episodes Recorded, Treatment-emergent confirmed hypoglycaemic episodes were recorded during weeks 0-31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Confirmed hypoglycaemic episode is an episode that is severe according to the American Diabetes Association (ADA) classification or plasma glucose value \<3.1 mmol/L with or without symptoms consistent with hypoglycaemia., Weeks 0-31
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 632
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-12-02
Completion Date: 2014-12-11
Results First Posted: 2019-11-05
Last Update Posted: 2021-01-15
Locations: Novo Nordisk Investigational Site, Tucson, Arizona, 85712, United States|Novo Nordisk Investigational Site, Chula Vista, California, 91911, United States|Novo Nordisk Investigational Site, Long Beach, California, 90806, United States|Novo Nordisk Investigational Site, Poway, California, 92064, United States|Novo Nordisk Investigational Site, Santa Ana, California, 92705, United States|Novo Nordisk Investigational Site, Spring Valley, California, 91978, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Colorado Springs, Colorado, 80904, United States|Novo Nordisk Investigational Site, Denver, Colorado, 80220, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32207, United States|Novo Nordisk Investigational Site, Miami, Florida, 33014, United States|Novo Nordisk Investigational Site, Plantation, Florida, 33324, United States|Novo Nordisk Investigational Site, South Miami, Florida, 33143, United States|Novo Nordisk Investigational Site, Athens, Georgia, 30606, United States|Novo Nordisk Investigational Site, Conyers, Georgia, 30094-5965, United States|Novo Nordisk Investigational Site, Addison, Illinois, 60101, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60634, United States|Novo Nordisk Investigational Site, Wichita, Kansas, 67205, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89103, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89109, United States|Novo Nordisk Investigational Site, New York, New York, 10001, United States|Novo Nordisk Investigational Site, New York, New York, 10032, United States|Novo Nordisk Investigational Site, Rochester, New York, 14609, United States|Novo Nordisk Investigational Site, Asheville, North Carolina, 28801, United States|Novo Nordisk Investigational Site, Raleigh, North Carolina, 27609, United States|Novo Nordisk Investigational Site, Salisbury, North Carolina, 28144, United States|Novo Nordisk Investigational Site, Fargo, North Dakota, 58104, United States|Novo Nordisk Investigational Site, Norman, Oklahoma, 73069, United States|Novo Nordisk Investigational Site, Jersey Shore, Pennsylvania, 17740, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19140, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19147, United States|Novo Nordisk Investigational Site, Moncks Corner, South Carolina, 29461, United States|Novo Nordisk Investigational Site, Humboldt, Tennessee, 38343, United States|Novo Nordisk Investigational Site, Spring Hill, Tennessee, 37174, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78209, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77478, United States|Novo Nordisk Investigational Site, Newport News, Virginia, 23606, United States|Novo Nordisk Investigational Site, Wenatchee, Washington, 98801-2028, United States|Novo Nordisk Investigational Site, Graz, 8036, Austria|Novo Nordisk Investigational Site, Saint Stefan, 8511, Austria|Novo Nordisk Investigational Site, Wien, 1010, Austria|Novo Nordisk Investigational Site, Wien, 1030, Austria|Novo Nordisk Investigational Site, Wien, 1060, Austria|Novo Nordisk Investigational Site, Wien, 1130, Austria|Novo Nordisk Investigational Site, Sofia, 1431, Bulgaria|Novo Nordisk Investigational Site, Bathurst, New Brunswick, E2A 4Z9, Canada|Novo Nordisk Investigational Site, Moncton, New Brunswick, E1G 1A7, Canada|Novo Nordisk Investigational Site, Burlington, Ontario, L7R 1E2, Canada|Novo Nordisk Investigational Site, Stayner, Ontario, L0M 1S0, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M9W 4L6, Canada|Novo Nordisk Investigational Site, Pointe-Claire, Quebec, H9R 3J1, Canada|Novo Nordisk Investigational Site, Aalborg, 9100, Denmark|Novo Nordisk Investigational Site, Esbjerg, 6700, Denmark|Novo Nordisk Investigational Site, Hellerup, 2900, Denmark|Novo Nordisk Investigational Site, Hillerød, 3400, Denmark|Novo Nordisk Investigational Site, Svendborg, 5700, Denmark|Novo Nordisk Investigational Site, Århus C, 8000, Denmark|Novo Nordisk Investigational Site, Elsterwerda, 04910, Germany|Novo Nordisk Investigational Site, Falkensee, 14612, Germany|Novo Nordisk Investigational Site, Friedrichsthal, 66299, Germany|Novo Nordisk Investigational Site, Hamburg, 22607, Germany|Novo Nordisk Investigational Site, Münster, 48145, Germany|Novo Nordisk Investigational Site, Saint Ingbert-Oberwürzbach, 66386, Germany|Novo Nordisk Investigational Site, Speyer, 67346, Germany|Novo Nordisk Investigational Site, Beer Sheva, 84101, Israel|Novo Nordisk Investigational Site, Haifa, 31096, Israel|Novo Nordisk Investigational Site, Herzliya, 46851, 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, Rishon Le Zion, 75650, Israel|Novo Nordisk Investigational Site, Milano, 20132, Italy|Novo Nordisk Investigational Site, Padova, 35128, Italy|Novo Nordisk Investigational Site, Roma, 00133, Italy|Novo Nordisk Investigational Site, Roma, 00161, Italy|Novo Nordisk Investigational Site, Verona, 37126, Italy|Novo Nordisk Investigational Site, Ipoh, 30450, Malaysia|Novo Nordisk Investigational Site, Kota Bharu, 15586, Malaysia|Novo Nordisk Investigational Site, Penang, 10450, Malaysia|Novo Nordisk Investigational Site, Seri Manjung, 32040, Malaysia|Novo Nordisk Investigational Site, Belgrade, 11000, Serbia|Novo Nordisk Investigational Site, Port Elizabeth, Eastern Cape, 6045, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1829, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 2090, South Africa|Novo Nordisk Investigational Site, Almería, 04001, Spain|Novo Nordisk Investigational Site, Sabadell, 08208, Spain|Novo Nordisk Investigational Site, Sevilla, 41003, Spain|Novo Nordisk Investigational Site, Sevilla, 41010, Spain|Novo Nordisk Investigational Site, Valencia, 46026, Spain|Novo Nordisk Investigational Site, Karlstad, 651 85, Sweden|Novo Nordisk Investigational Site, Linköping, 582 16, Sweden|Novo Nordisk Investigational Site, Oskarshamn, 572 28, Sweden|Novo Nordisk Investigational Site, Örebro, 701 85, Sweden|Novo Nordisk Investigational Site, Belfast, BT16 1RH, United Kingdom|Novo Nordisk Investigational Site, Bexhill-on-Sea, TN39 4SP, United Kingdom|Novo Nordisk Investigational Site, Chesterfield, Derbyshire, S40 4AA, United Kingdom|Novo Nordisk Investigational Site, Chester, CH2 1UL, United Kingdom|Novo Nordisk Investigational Site, Crewe, CW5 5NX, United Kingdom|Novo Nordisk Investigational Site, Hinckley, LE10 2SE, United Kingdom|Novo Nordisk Investigational Site, Leicester, LE5 4PW, United Kingdom|Novo Nordisk Investigational Site, London, W6 7HY, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01923181

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress