Clinical Trials
We also have the possibility of conducting studies that require hospital admission, at the “Phase I facility” of the Institute for Biomedical Research of Málaga (IBIMA).
The research projects and clinical trials in which we participate are evaluated by the Malaga’s Provincial Research Ethic Committee (CEI), as an essential and mandatory instrument for the authorization and control of this research activity. We also rely, within IBIMA, on the clinical trials platform to guarantee top excellence, effectiveness and efficiency, as well as collaborate with other health centres, scientific associations, Contract Research organizations (CRO) and biotechnological, pharmaceutical and nutritional industry.
PRINCIPAL INVESTIGATOR
Dra. Francisca Linares Parrado:
UGC Endocrinología y Nutrición
Hospital Regional de Málaga – Instituto de Investigación Biomédica de Málaga –
IBIMA
Unidad de Ensayos Clínicos Pabellón 2, Planta baja, Hospital Civil
Plaza del Hospital Civil s/n,
29009, Malaga (Spain)
Teléfono: +34951290305/+34659894533
Contact
Ongoing and finished Clinical trials in the last 5 years
Kreon N. - M13-621 (Phase IIIb) A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis.
INVESTIGADOR PRINCIPAL: Gabriel Olveira Fuster
Nº EudraCT: 2013-002819-10
2014-2015
PROMOTOR: Abbott Laboratories GmbH
CSOM230B2411 (Phase II) A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's disease.
INVESTIGADOR PRINCIPAL: Silvia Maraver
EudraCT: 2013-002170-49
2014-2017
PROMOTOR: Novartis
SPIRE 1.- B1481022 (Phase III) Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of Bococizumab (PF-04950615), in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects.
INVESTIGADOR PRINCIPAL: Marta Domínguez López
Nº EudraCT: 2013-002646-36
2015-2017
PROMOTOR: Pfizer
SPIRE 2 .- B1481038 (Phase III) Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of Bococizumab (PF-04950615), in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects.
INVESTIGADOR PRINCIPAL: Marta Domínguez López
Nº EudraCT: 2013-002795-41
2015-2017
PROMOTOR: Pzifer
PTC124-GD-021-CF (Phase III) Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis.
INVESTIGADOR PRINCIPAL: Gabriel Olveira Fuster
Nº EudraCT: 2013-004581-34
2015-2017
PROMOTOR: PTC Therapeutics Inc.
PTC124-GD-021e-CF (Phase III) Extension Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis.
INVESTIGADOR PRINCIPAL: Gabriel Olveira Fuster
Nº EudraCT: 2014-005355-83
2016-2017
PROMOTOR : PTC Therapeutics Inc.
SOLUTION .- AN-EPI3331 (Phase III) Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic deficiency.
INVESTIGADOR PRINCIPAL: Gabril Olveira
Nº EUDRACT No. 2015-002739-17
2015-2016
PROMOTOR: Anthera Pharmaceuticals, Inc.
THERACOS 1.-THR-1442-C-448 (Phase III) A double blind placebo controlled study to evaluate the effect of bexagliflozin tablets on hemoglobin A1c in patients with type 2 diabetes mellitus and moderate renal impairment.
INVESTIGADOR PRINCIPAL: Sergio Valdés
Nº EudraCT: 2016-002580-34
2016-2018
PROMOTOR: Novartis
THERACOS 2.-THR-1442-C-480 (Phase III) Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of Bexagliflozin versus Glimepiride in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control.
INVESTIGADOR PRINCIPAL: Sergio Valdés
Nº EudraCT: 2016-002013-21
2016- 2019
PROMOTOR: Novartis
CREDENCE.- 28431754DNE3001(Phase III) A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy.
INVESTIGADOR PRINCIPAL: Marta Domínguez López
Nº EudraCT: 2013-004494-28
2014-2018
PROMOTOR: Janssen
CARMELINA.- 1218.22 (Phase IV) A multicenter, international, randomized, parallel group, double blind, placebo-controlled CArdiovascular Safety & Renal Microvascular outcomE study with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk.
INVESTIGADOR PRINCIPAL: Sergio Valdés
Nº EudraCT: 2011-4148-23
2014-2018
PROMOTOR: Boehringer Ingelheim
DRI13940 (Phase II) A 26-Week Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study to Assess the Safety and Efficacy of SAR425899 in Patients with Type 2 Diabetes Mellitus.
INVESTIGADOR PRINCIPAL: Sergio Valdés
Nº EudraCT: 2016-001328-77
2017-2018
PROMOTOR: Sanofi
LINC4 .- CLCI699C2302 (Phase III) A Phase III, multi-center, randomized, double-blind, 48 week study with an initial 12 week placebo-controlled period to evaluate the safety and efficacy of osilodrostat in patients with Cushing’s disease.
INVESTIGADOR PRINCIPAL: Inmaculada González
Nº EudraCT: 2014-004092-23
2016-Actualidad
PROMOTOR: Novartis
ACRONIS.- C-SOM230CIC05 (Phase IV) European observational study of Pasireotide LAR in acromegaly.
INVESTIGADOR PRINCIPAL: Inmaculada González
2016-Actualidad
PROMOTOR: Novartis
RESULT .- AN-EPI3333 (Phase III) Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic deficiency.
INVESTIGADOR PRINCIPAL: Gabriel Olveira
Nº EudraCT No. 2017-000571-85
2015-2017
PROMOTOR: Anthera Pharmaceuticals, Inc.
PROMINENT.- K-877-302 (Phase III) Pemafibrate to Reduce cardiovascular OutcoMes by reducing triglycerides IN patiENts with diabeTes.
INVESTIGADOR PRINCIPAL: Inmaculada González
Nº EudraCT: 2016-003818-26
2017 -Actualidad
PROMOTOR: KOWA
SORELLA 1.- EFC 12619 (Phase III) Six-month, Randomized, Open-label, Parallel-group Comparison of SAR342434 to Humalog® in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine, with a 6-month Safety Extension Period.
INVESTIGADOR PRINCIPAL: Soledad Ruiz de Adana
Nº EudraCT: 2013-002945-12
2014-2016
PROMOTOR: Sanofi
SORELLA 2.- EFC 13403 (Phase III) Six-month, Randomized, Open-label, Parallel-group Comparison of the Insulin Analog SAR342434 to Humalog® in Adult Patients With Type 2 Diabetes Mellitus also Using Insulin Glargine.
INVESTIGADOR PRINCIPAL: Soledad Ruiz de Adana
Nº EudraCT: 2014-002844-42
2015-2016
PROMOTOR: Sanofi
PANC2002 (Phase II) Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis.
INVESTIGADOR PRINCIPAL: Gabriel Olveira Fuster
Nº EudraCT: 2014-004519-35
2015-2016
PROMOTOR: Abbott Laboratories GmbH
PRE-INTENSE.- SAN-INS-2013-01 (Phase IV) Predictive factors of glycated hemoglobin (HbA1c) control and the need for intensification in patients with type 2 DM with controlled glucose values and on treatment with basal insulin.
INVESTIGADOR PRINCIPAL: Natalia Colomo
2014
PROMOTOR: Sanofi
INTENSE.- SAN-LIX-2014-01 (Observational study) Real-world effectiveness of Lixisenatide and other intensification treatments in patients with type 2 diabetes uncontrolled on basal insulin.
INVESTIGADOR PRINCIPAL: Francisco Tinahones Madueño
2015-2017
PROMOTOR: Sanofi
DIAGNODE-2 (D/P2/17/6) (Phase: IIb) A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd® Therapy Administered into Lymph Nodes Combined with Oral Vitamin D to Investigate the Impact on the Progression of Type 1 diabetes
INVESTIGADOR PRINCIPAL: Marisol Ruiz de Adana
EudraCT Number: 2017-001861-25
2019- Actualidad
PROMOTOR: Diamyd Medical AB
Estudio Nut-ADH- 2.4kcal.- Compliance with a high-energy, low-volume Oral Nutritional Supplement.
INVESTIGADOR PRINCIPAL: Gabriel Olveira
Código de Protocolo: Nut-ADH 2.4
PROMOTOR: Nutricia
Estudio SAPPHIRE.- D5495C00002 (Phase IIb), Multicentre, Randomised, Double-blind, Placebo-controlled Study of Verinurad and Allopurinol in Patients with Chronic Kidney Disease and Hyperuricaemia.
EudraCT: 2018-004079-11
2019-Actualidad
PROMOTOR: Astrazeneca Pharmaceuticals LP.
Available Techniques
Balfegó M, Canivell S, Hanzu FA, Sala-Vila A, Martínez-Medina M, Murillo S, Mur T, Ruano EG, Linares F, Porras N, Valladares S, Fontalba M, Roura E, Novials A, Hernández C, Aranda G, Sisó-Almirall A, Rojo-Martínez G, Simó R, Gomis R. Effects of sardine-enriched diet on metabolic control, inflammation and gut microbiota in drug-naïve patients with type 2 diabetes: a pilot randomized trial. Lipids Health Dis. 2016 Apr 18;15:78. doi: 10.1186/s12944-016-0245-0. PMID: 27090218.
Ruiz de Adana MS, Colomo N, Maldonado-Araque C, Fontalba MI, Linares F, García-Torres F, Fernández R, Bautista C, Olveira G, de la Cruz JL, Rojo-Martínez G, Valdés S. Randomized clinical trial of the efficacy and safety of insulin glargine vs. NPH insulin as basal insulin for the treatment of glucocorticoid induced hyperglycemia using continuous glucose monitoring in hospitalized patients with type 2 diabetes and respiratory disease. Diabetes Res Clin Pract. 2015 Nov;110(2):158-65. doi: 10.1016/j.diabres.2015.09.015. Epub 2015 Sep 30. PMID: 26474657.
