spironolactone and Diabetes Mellitus

spironolactone has been researched along with Diabetes Mellitus in 36 studies

Spironolactone: A potassium sparing diuretic that acts by antagonism of aldosterone in the distal renal tubules. It is used mainly in the treatment of refractory edema in patients with congestive heart failure, nephrotic syndrome, or hepatic cirrhosis. Its effects on the endocrine system are utilized in the treatments of hirsutism and acne but they can lead to adverse effects. (From Martindale, The Extra Pharmacopoeia, 30th ed, p827)
spironolactone : A steroid lactone that is 17alpha-pregn-4-ene-21,17-carbolactone substituted by an oxo group at position 3 and an alpha-acetylsulfanyl group at position 7.

Diabetes Mellitus: A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE.

Research

Studies (36)

Authors

Clinical Trials (8)

Trial Overview

Trial Outcomes

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated)

CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011)

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date

CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)

Number of Participants With First Occurrence of All-Cause Hospitalization (Adjudicated)

Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated)

Death due to any cause. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Number of Participants With First Occurrence of All-Cause Mortality or All-Cause Hospitalization (Adjudicated)

Death due to any cause or hospitalization due to any cause. Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated)

Death due to any cause or first of occurrence HF hospitalization. HF hospitalization is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization (Adjudicated)

First occurrence of CV hospitalization. CV hospitalization is defined as hospitalization due to HF (first or subsequent), acute myocardial infarction, angina pectoris (unstable), cardiac arrhythmia (atrial fibrillation [AF], atrial flutter, supraventricular arrhythmias, or ventricular arrhythmias), stroke/CVA, other CV reasons (such as hypotension or peripheral vascular disease), implantation of a cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) with CV event as the primary reason for hospitalization as determined by endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality (Adjudicated)

CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Number of Participants With First Occurrence of Fatal or Non-fatal Myocardial Infarction (Adjudicated)

(NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Number of Participants With First Occurrence of Fatal or Non-fatal Stroke (Adjudicated)

(NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Number of Participants With First Occurrence of Heart Failure (HF) Hospitalization (Adjudicated)

First occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Number of Participants With First Occurrence Of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization (Adjudicated)

Death due to HF or first occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Number of Participants With First Occurrence of Hospitalization Due to Hyperkalemia (Adjudicated)

First occurrence of hospitalization due to hyperkalemia. Hospitalization due to hyperkalemia is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to hyperkalemia as the primary reason for hospitalization as determined by endpoint committee adjudicator. Hyperkalemia is defined as serum potassium level greater than (>) 5.5 milliequivalents per liter (mEq/L). (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Number of Participants With First Occurrence of Hospitalization Due to Worsening Renal Function (Adjudicated)

First occurrence of hospitalization due to worsening renal function. Hospitalization due to worsening renal function is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to worsening renal function as the primary reason for hospitalization as determined by endpoint committee adjudicator. Worsening renal function is defined as doubling of serum creatinine level from baseline level. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Number of Participants With First Occurrence of Implantation of Cardiac Defibrillator (ICD) (Adjudicated)

First occurrence of implantation of cardiac defibrillator (ICD). ICD is an electronic device capable of monitoring the heart rhythm. When the heart is beating normally, the device remains inactive. If the heart develops a life-threatening tachycardia, the ICD delivers electrical shocks to the heart to terminate the abnormal rhythm and return the heart rhythm to normal. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Number of Participants With First Occurrence of Implantation of Resynchronization Device (Cardiac Resynchronization Therapy [CRT]) (Adjudicated)

First occurrence of implantation of resynchronization device. CRT is use of a specialized pacemaker to re-coordinate the action of the right and left ventricles in heart failure. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Number of Participants With New Onset Atrial Fibrillation or Flutter

New onset of atrial fibrillation or flutter is defined as the diagnosis of atrial fibrillation or flutter in a participant after randomization, where atrial fibrillation was not present before randomization. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Number of Participants With New Onset Diabetes Mellitus (DM)

The definition of new onset diabetes mellitus is the diagnosis of diabetes mellitus in a participant after randomization, when DM was not present before randomization. (NCT00232180)
Timeframe: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Aborted Cardiac Arrest

First incidence of aborted cardiac arrest (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

All-cause Mortality

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Cardiovascular Mortality

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Cardiovascular-related Hospitalization

Hospitalization for MI, stroke or the management of heart failure, whichever occurred first (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Chloride

Average post-baseline Chloride, taking into consideration baseline Chloride, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred First

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred First

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Composite Outcome of Sudden Death, Aborted Cardiac Arrest, or Hospitalization for the Management of Ventricular Tachycardia, Whichever Occurred First

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Depression Symptoms, as Measured by Patient Health Questionnaire.

"Average post-baseline depression, taking into consideration baseline depression, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The Patient Health Questionnaire (PHQ) is a 10-item, self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores can range from 0-27, in which lower scores reflect better mental health status. The PH-Q was administered at the following study visits: baseline, month 12 and annually thereafter. Valid translations of this questionnaire were only available for subjects enrolled in the United States and Canada." (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Deterioration of Renal Function

First incidence of a deterioration of renal function. The TOPCAT protocol defines deterioration of renal function as occurring if a subject has a serum creatinine value which is at least double the baseline value for that subject, and is also above the upper limit of normal (assumed to be 1.0 mg/dL for females and 1.2 mg/dL for males.) (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Development of Atrial Fibrillation, Among Subjects Without a History of Atrial Fibrillation at Baseline.

First incidence of atrial fibrillation among subjects without a history of atrial fibrillation at baseline (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Estimated Glomerular Filtration Rate (GFR)

Average post-baseline GFR, taking into consideration baseline GFR, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Hospitalization for Any Reason

First incidence of a hospitalization for any reason (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Hospitalization for the Management of Heart Failure

First incidence of a hospitalization for the management of heart failure (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Myocardial Infarction

First incidence of myocardial infarction (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline.

First incidence of new onset diabetes mellitus among subjects without a history of diabetes mellitus at baseline. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Potassium

Average post-baseline Potassium, taking into consideration baseline Potassium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Quality of Life, as Measured by McMaster Overall Treatment Evaluation Questionnaire.

"Average post-baseline quality of life, taking into consideration baseline quality of life and treatment group.~The McMaster Overall Treatment Evaluation questionnaire is a self-administered 3-item instrument that measures a patient's perception of change in their health-related quality of life since the start of therapy. The questionnaire consists of a single question - Since treatment started, has there been any change in your activity limitation, symptoms and/or feelings related to your heart condition? Scores can range from -7 to +7, and higher scores reflect better health status. The questionnaire was administered at the following study visits: month 4 and month 12. Valid translations of this questionnaire were only available for subjects enrolled in the United States, Canada and Argentina." (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Quality of Life, as Measured by the EuroQOL Visual Analog Scale.

"Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The EuroQOL visual analog scale (EQ5D) is a single-item, self-administered instrument that quantifies current health status. Scores can range from 0-100, in which higher scores reflect better health status. The EQ5D was administered at the following study visits: baseline, month 4, month 12 and annually thereafter." (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Quality of Life, as Measured by the Kansas City Cardiomyopathy Questionnaire.

"Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The KCCQ was administered at the following study visits: baseline, month 4, month 12 and annually thereafter." (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Serum Creatinine

Average post-baseline serum creatinine, taking into consideration baseline serum creatinine, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Sodium

Average post-baseline Sodium, taking into consideration baseline Sodium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Stroke

First incidence of stroke (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90

N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute and chronic heart failure (CHF) and may be useful to establish prognosis in heart failure. (NCT01807221)
Timeframe: Baseline and Day 90

Change From Baseline in Diastolic Blood Pressure at Specified Visits

(NCT01807221)
Timeframe: Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits

EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L): participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state. (NCT01807221)
Timeframe: Baseline, Day 30, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

Change From Baseline in Heart Rate at Specified Visits

(NCT01807221)
Timeframe: Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

Change From Baseline in KCCQ Questionnaire Scores at Specified Visits

The Kansas City Cardiomyopathy Questionnaire (KCCQ) was the leading health related quality of life measure for subjects with CHF. KCCQ was a 23 item questionnaire that independently measures the impact of subjects HF, or its treatment, on 7 distinct domains: self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Results from the total symptom summary score are presented. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. In the below table, categorical data represents change from baseline data at respective time points. (NCT01807221)
Timeframe: Baseline, Day 30 and Day 90

Change From Baseline in Serum Potassium at Specified Visits

(NCT01807221)
Timeframe: Baseline, Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)

Change From Baseline in Systolic Blood Pressure at Specified Visits

(NCT01807221)
Timeframe: Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

Number of Participants With Cardiovascular Hospitalization

Hospitalizations were defined as any unplanned admission to hospital, i.e. completion of hospital admission procedures and one overnight [i.e. date change] stay or until the death of subject occurred. Hospitalizations and deaths were classified by 2 primary categories: CV and non-CV. The pre-specified subcategories for CV hospitalizations were as follows: 1. Worsening heart failure, 2.Acute myocardial infarction, 3. Arrhythmia, 4.Transient ischemic attack and stroke, 5. Other CV hospitalizations. (NCT01807221)
Timeframe: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)

Number of Participants With Death Due to Any Cause

Death due to any cause include cardiovascular (CV) death and Non-CV death. Non-CV death was classified by 2 subcategories: non-malignant causes and malignant causes. (NCT01807221)
Timeframe: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)

Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF)

Emergency presentations for WCHF were defined as newly developing signs and symptoms of WCHF after start of treatment with study drug, requiring an additional emergency presentation to hospital and IV treatment with diuretics and/or positive inotropic agents. (NCT01807221)
Timeframe: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)

Ratio of BNP at Specified Visits to BNP at Baseline

B-type natriuretic peptide (BNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure. (NCT01807221)
Timeframe: Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline

N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure. (NCT01807221)
Timeframe: Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)

Reviews

6 reviews available for spironolactone and Diabetes Mellitus

Trials

7 trials available for spironolactone and Diabetes Mellitus

Other Studies

23 other studies available for spironolactone and Diabetes Mellitus