STUDY OF THE EFFICACY AND SAFETY OF LIRAGLUTIDE IN TYPE 2 DIABETIC PATIENTS HOSPITALIZED WITH ACUTE CORONARY SYNDROME. IMPACT ON CARDIOVASCULAR RISK FACTOR.

STUDY OF THE EFFICACY AND SAFETY MANAGEMENT OF LIRAGLUTIDE IN TYPE 2 DIABETIC PATIENTS HOSPITALIZED WITH ACUTE CORONARY SYNDROME. IMPACT ON CARDIOVASCULAR RISK FACTOR. - SCALES

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003298-40-ES

Enrollment

Registered

2014-11-19

Start date

2014-12-15

Completion date

Unknown

Last updated

2018-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TYPE 2 DIABETIC HOSPITALIZED PATIENTS WITH ACUTE CORONARY SYNDROME.

Interventions

Trade Name: VICTOZA Product Name: liraglutide Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe Trade Name: LANTUS Product Name: glargine insulin Pharmaceutical Form: Solutio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 18-80 years hospitalized patients with acute coronary syndrome and diagnosed with type 2 diabetes for more than 3 months and an admission plasma glucose between 140-400 mg / dL. - In treatment with diet, oral agents in any combination or lower daily dose of insulin at 0.4 IU / kg. - Patients who have signed the Informed Consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: - Those patients with admission plasma glucose> 400 mg / dL were excluded. - Patients with hyperglycemia on admission but without diagnosed diabetes. - Patients with a history of diabetic ketoacidosis. - Patients with a severe disease that may include cardiac surgery or intensive care stay. - Patients with a history of pancreatitis or biliary tract active disease . - Patients with hepatic or renal failure (GFR <60 mL / min / 1.73m2). - Pregnancy, lactation. - Mental disease. - Patients who do not sign the informed consent. - Patients with kidney, liver, adrenal, pituitary or thyroid gland problems.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To study the efficacy of glycemic control with the use of liraglutide in hospitals defined by glicosilated hemoglobin. - To study the impact of liraglutide on cardiovascular risk factors.;Secondary Objective: - To study the safety of liraglutide in hospitals. - To study the usefulness of liraglutide in oxidative stress markers 3 months after the acute coronary event. - To study glycemic variability and incidence of hypoglycemia during hospitalization in patients included in each group. - To study the usefulness of 1.5 anhydroglucitol on these patients as an indirect measure of glycemic variability. - To study the efficacy of glycemic control with the use of liraglutide in hospitals defined by the mean pre and postprandial glycemia.;Primary end point(s): - Efficacy of liraglutide: - Differences glycosylated hemoglogine recorded during the study. -Number Glycemia in the objectives range set in admission. - Impact of liraglutide CVRF - Change in SCORE cardiovascular risk corresponding to SPAIN.;Timepoint(s) of evaluation of this end point: -Hospital Admission -Hospital Stay -Hospital Discharge -Weekly phone Control (11 weeks) -Visit Week 12 -Visit Week 16	—

Measure

Time frame

Main Objective: - To study the efficacy of glycemic control with the use of liraglutide in hospitals defined by glicosilated hemoglobin. - To study the impact of liraglutide on cardiovascular risk factors.;Secondary Objective: - To study the safety of liraglutide in hospitals. - To study the usefulness of liraglutide in oxidative stress markers 3 months after the acute coronary event. - To study glycemic variability and incidence of hypoglycemia during hospitalization in patients included in each group. - To study the usefulness of 1.5 anhydroglucitol on these patients as an indirect measure of glycemic variability. - To study the efficacy of glycemic control with the use of liraglutide in hospitals defined by the mean pre and postprandial glycemia.;Primary end point(s): - Efficacy of liraglutide: - Differences glycosylated hemoglogine recorded during the study. -Number Glycemia in the objectives range set in admission. - Impact of liraglutide CVRF - Change in SCORE cardiovascular risk corresponding to SPAIN.;Timepoint(s) of evaluation of this end point: -Hospital Admission -Hospital Stay -Hospital Discharge -Weekly phone Control (11 weeks) -Visit Week 12 -Visit Week 16

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: -Hospital Admission -Hospital Stay -Hospital Discharge -Weekly phone Control (11 weeks) -Visit Week 12 -Visit Week 16;Secondary end point(s): - Safety of Liraglutide: - Number of hypoglycaemia during hospitalization. - Number of severe hypoglycemia. - Risk of hypoglycemia determined by iPRO sensor calibration algorithm. - Risk of hyperglycemia determined by iPRO sensor calibration algorithm. - Number of glycemia out of range. - Utility liraglutide in oxidative stress markers: - Changes in the levels of oxidative stress markers from baseline after 3 months of treatment. - Glycemic variability and incidence of hypoglycemia: - Number of severe hypoglycemia during the entire hospitalization. - Risk of hypoglycemia determined by iPRO sensor calibration algorithm. - Comparison of glycemic variability using the standard deviation obtained by digital blood glucose and obtained iPRO sensor. - Utility of 1.5 anhydroglucitol: - Change in basal levels anhydroglucitol 1.5 and 3 months compared with previously obtained glycemic variability.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: -Hospital Admission -Hospital Stay -Hospital Discharge -Weekly phone Control (11 weeks) -Visit Week 12 -Visit Week 16;Secondary end point(s): - Safety of Liraglutide: - Number of hypoglycaemia during hospitalization. - Number of severe hypoglycemia. - Risk of hypoglycemia determined by iPRO sensor calibration algorithm. - Risk of hyperglycemia determined by iPRO sensor calibration algorithm. - Number of glycemia out of range. - Utility liraglutide in oxidative stress markers: - Changes in the levels of oxidative stress markers from baseline after 3 months of treatment. - Glycemic variability and incidence of hypoglycemia: - Number of severe hypoglycemia during the entire hospitalization. - Risk of hypoglycemia determined by iPRO sensor calibration algorithm. - Comparison of glycemic variability using the standard deviation obtained by digital blood glucose and obtained iPRO sensor. - Utility of 1.5 anhydroglucitol: - Change in basal levels anhydroglucitol 1.5 and 3 months compared with previously obtained glycemic variability.

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Countries

Spain

Contacts

Public ContactUREC

IIS La Fe

investigacion_clinica@iislafe.es+34961246611

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026