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Clinical Trial Details

Trial ID: L2886
Source ID: NCT04023344
Associated Drug: Humalog Mix25
Title: Efficacy and Safety of Insulin Lispro Biphasic 25 Compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Diabetes Mellitus
Interventions: DRUG: Humalog Mix25|DRUG: Insulin Lispro Biphasic 25
Outcome Measures: Primary: Antibody Response, Change from baseline in titer of antibodies to human insulin, 26 weeks | Secondary: Adverse Events frequency and degree, Hypoglycemic episodes (glucose level \< 3.9 mmol/l) frequency Occurrence of local reactions at injection sites Occurrence allergic reactions, 26 weeks (4+22 weeks)|HbA1c, Change in HbA1c from baseline, 26 weeks|Fasting Plasma Glucose Level, Change in fasting plasma glucose level from baseline, 26 weeks|Seven-Point Glucose Testing, Change in seven-point glucose testing results from baseline, 26 weeks|Insulin Dose, Change in total insulin dose per body weight (U/kg) from baseline, 26 weeks|Body Mass Index, Change in BMI from baseline, 26 weeks|Treatment Satisfaction, Change in overall treatment satisfaction (DTSQ score) from baseline, 26 weeks
Sponsor/Collaborators: Sponsor: Geropharm
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 210
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-03-14
Completion Date: 2019-04-18
Results First Posted:
Last Update Posted: 2019-07-17
Locations: Chelyabinsk Railway Clinical Hospital, Chelyabinsk, 454000, Russian Federation|Railway Clinical Hospital N.A. Semashko, Moscow, 109386, Russian Federation|Endocrinology Research Centre (Moscow), Moscow, 117036, Russian Federation|Moscow Endocrinological Dispensary, Moscow, 119034, Russian Federation|Nizhny Novgorod Regional Clinical Hospital, Nizhny Novgorod, 603126, Russian Federation|V.A. Baranov Republic Hospital, Petrozavodsk, 185000, Russian Federation|Rostov State Medical University, Rostov-on-Don, 344022, Russian Federation|City Polyclinic № 77, Saint Petersburg, 192177, Russian Federation|City Hospital № 2, Saint Petersburg, 194354, Russian Federation|City Polyclinic № 117, Saint Petersburg, 194358, Russian Federation|City Polyclinic № 17, Saint Petersburg, 195176, Russian Federation|Institute of Medical Research, Saint Petersburg, 196084, Russian Federation|Research Center Eco-Safety, Saint Petersburg, 196143, Russian Federation|City Hospital №40, Saint Petersburg, 197706, Russian Federation|Pokrovskaya Municipal Hospital, Saint Petersburg, 199106, Russian Federation|Diabetes Center, Samara, 443067, Russian Federation|Clinical City Hospital № 9, Saratov, 410030, Russian Federation|Siberian State Medical University, Tomsk, 634050, Russian Federation
URL: https://clinicaltrials.gov/show/NCT04023344

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress