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Clinical Trial Details

Trial ID: L4082
Source ID: NCT03230786
Associated Drug: Daily Injection Of Kbp/Placebo For 12 Weeks As Add-On To Metformin
Title: Study to Evaluate the Efficacy and Safety of KBP-042 in Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Daily injection of KBP/placebo for 12 weeks as add-on to metformin
Outcome Measures: Primary: Change from baseline in blood HbA1c at 12 weeks versus placebo., At 12 weeks | Secondary: Change from baseline in body weight at 12 weeks versus placebo., At 12 weeks|Change from baseline in fasting serum glucose at 12 weeks versus placebo, At 12 weeks|Change from baseline in fasting serum insulin at 12 weeks versus placebo, At 12 weeks|Change from baseline in fasting serum glucagon at 12 weeks versus placebo, At 12 weeks|Proportion of subjects reaching a level of HbA1c below 7.0% (53 mmol/mol) at 12 weeks versus placebo, At 12 weeks
Sponsor/Collaborators: Sponsor: KeyBioscience AG | Collaborators: Nordic Bioscience A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 255
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-08-23
Completion Date: 2018-07-31
Results First Posted:
Last Update Posted: 2018-09-11
Locations: Vdoviak Miroslav MUDr. - Interní Ambulance, Karlovy Vary, 360 17, Czechia|General University Hospital, Prague 2, 128 00, Czechia|Institute for Clinical and experimental Medicine, Praha 4, 140 21, Czechia|Interní a Diabetologická ambulance, Clintrial s.r.o, Praha, 100 00, Czechia|Endokrinologicky Ústav, Praha, 113 94, Czechia|Diabet2 s.r.o, Praha, Czechia|Interní a Diabetologická ambulance, Uherské Hradiště, 68 601, Czechia|Diabetologická a Obezitologická ambulance, České Budějovice, Czechia|Bispebjerg Hospital, Endokrinologisk Afdeling, Bispebjerg, Copenhagen NV, 2400, Denmark|Bioclinica, Ballerup, Copenhagen, 2750, Denmark|Bioclinica, Aalborg, Jutland, 9000, Denmark|Aarhus University Hospital, Endocrinlogy Department, Aarhus, Jutland, 8000, Denmark|Sydvestjysk Sygehus, Esbjerg, Jutland, 6700, Denmark|Bioclinica, Vejle, Jutland, 7100, Denmark|Holbæk Sygehus, Holbæk, 4300, Denmark|Rtl Sm Srl/Scr, Chisinau, MD2025, Moldova, Republic of|Rtl Sm Srl, Chisinau, MD2025, Moldova, Republic of|Centrum Badań Klinicznych PI-House sp. z o.o., Gdańsk, 80-546, Poland|Specjalistyczna Praktyka Lekarska Piotr Kubalski, Grudziądz, 86-302, Poland|Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczno, Kraków, 31-261, Poland|Prywatny Gabinet Lekarski M. Horodecki (budynek Medicus), Opole, 45-367, Poland|Centrum Medyczne Hygea, Tychy, 43-100, Poland|Centrum Medyczne AMED, Warsaw, 01-518, Poland|Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer, Łódź, 90-074, Poland|S.C. Policlinica CCBR S.R.L., Bucharest, 030463, Romania|Institutului Național de Diabet, Nutriție și Boli Metabolice "Prof.Dr. N.C. Paulescu", Bucharest, Romania|S.C Nicodiab S.R.L., Bucharest, Romania|S.C. Sfinx Medica S.R.L., Constanţa, 900412, Romania|S.C. Mediab S.R.L., Targu Mures, Romania|S.C. Mediab S.R.L., Târgu-Mureş, Romania|St. Pancras, London, WC1X 8QD, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03230786

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