You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 5, 2024

CLINICAL TRIALS PROFILE FOR GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00225264 ↗ Efficacy Study of Pioglitazone and Glimepiride on the Rate of Progression of Atherosclerotic Disease. Completed Takeda Phase 3 2003-10-01 The primary purpose of this study is to compare the effects of pioglitazone, once daily (QD), versus glimepiride on the amount of thickening of the carotid artery.
NCT00225277 ↗ Efficacy Study of Pioglitazone Compared to Glimepiride on Coronary Atherosclerotic Disease Progression in Subjects With Type 2 Diabetes Mellitus Completed Takeda Phase 3 2003-07-01 The purpose of this study was to determine the efficacy of pioglitazone, once daily (QD), compared to glimepiride on atherosclerotic disease measured by intravascular ultrasound.
NCT00576784 ↗ Metabolic Effects of Pioglitazone in Type II Diabetic Patients Previously Treated With Insulin Completed IKFE Institute for Clinical Research and Development Phase 4 2005-04-01 The goal of the study is to demonstrate whether a switch from insulin therapy to an oral therapy with pioglitazone/glimepiride will lead to a deterioration of glycemic control (increase in HbA1c by more than 0.5 %) within a 6 month observation period.
NCT00700856 ↗ Thiazolidinediones Or Sulphonylureas and Cardiovascular Accidents.Intervention Trial Unknown status Associazione Medici Diabetologi (AMD) Phase 4 2008-09-01 Background: In patients with type 2 diabetes inadequately controlled with metformin, two main therapeutic options are equally plausible: add-on a sulfonylurea (SU) or a thiazolidinedione (TZD). Since the two classes of drugs clearly differ in terms of mechanisms of action, side effects, economic costs and cardiovascular risk factors profile, a direct comparison of the two therapeutic strategies would be most appropriate. Aims: 1) To evaluate the effects of add-on pioglitazone as compared with add-on a SU on the incidence of cardiovascular events in type 2 diabetic patients inadequately controlled with metformin; 2) To compare the two treatments in terms of glycemic control, safety, and economic costs. Methods: multicentre, randomised, open label, parallel group trial of 48 months duration. Eligible participants (type 2 diabetic males and females, aged 50-75 years, BMI 20-45 Kg/m2, in treatment for the last two months with metformin 2 gr/die in monotherapy and with HbA1c > =7.0% and <= 9.0%) will be randomized to add-on: a SU - glibenclamide (5-15 mg/die), gliclazide (30-120 mg/die), glimepiride (2-6 mg/die), chosen according to local practice - or pioglitazone (15-45 mg/die). A HbA1c value > 8.0 % on two consecutive occasions will lead to addition of insulin to ongoing oral therapy. Primary efficacy outcome: a composite endpoint of all-cause mortality, non fatal MI (including silent MI), non fatal stroke, and unplanned coronary revascularization. Secondary outcomes. Principal secondary outcome: a composite ischemic endpoint of sudden death, fatal and non fatal acute MI (including silent MI), fatal and non fatal stroke, major amputations (above ankle), endovascular or surgical intervention on the coronary, leg or carotid arteries. Other secondary outcomes - a composite cardiovascular end point including the primary end point plus hospitalization for heart failure, endovascular or surgical intervention on the coronary, leg or carotid arteries, silent MI, angina - by WHO criteria and confirmed by a new electrocardiogram abnormality - intermittent claudication with an ankle/brachial index lower than 090; events of heart failure; a microvascular endpoint including: plasma creatinine increase of 2 times above the baseline value or creatinine clearance reduction of 20ml/min/1. 73m2 or development of overt nephropathy (dialysis or plasma creatinine >3,3 mg/dl) or macroalbuminuria; glycemic control (changes from baseline in HBA1c, time to failure of glycemic control, i.e., HBA1c >8.0% on two consecutive occasions three months apart); major CV risk factors (lipids, blood pressure, microalbuminuria, inflammation markers, waist circumference); safety and side effects; direct and indirect costs. Data regarding CV endpoints, safety, tolerability, and study conduct will be monitored and analyzed by an independent committee, and will be not available to the study investigators until the closing of data collection. Efficacy end points will be analyzed on an intention-to-treat basis.
NCT00700856 ↗ Thiazolidinediones Or Sulphonylureas and Cardiovascular Accidents.Intervention Trial Unknown status Associazione Nazionale Medici Cardiologi Ospedalieri Phase 4 2008-09-01 Background: In patients with type 2 diabetes inadequately controlled with metformin, two main therapeutic options are equally plausible: add-on a sulfonylurea (SU) or a thiazolidinedione (TZD). Since the two classes of drugs clearly differ in terms of mechanisms of action, side effects, economic costs and cardiovascular risk factors profile, a direct comparison of the two therapeutic strategies would be most appropriate. Aims: 1) To evaluate the effects of add-on pioglitazone as compared with add-on a SU on the incidence of cardiovascular events in type 2 diabetic patients inadequately controlled with metformin; 2) To compare the two treatments in terms of glycemic control, safety, and economic costs. Methods: multicentre, randomised, open label, parallel group trial of 48 months duration. Eligible participants (type 2 diabetic males and females, aged 50-75 years, BMI 20-45 Kg/m2, in treatment for the last two months with metformin 2 gr/die in monotherapy and with HbA1c > =7.0% and <= 9.0%) will be randomized to add-on: a SU - glibenclamide (5-15 mg/die), gliclazide (30-120 mg/die), glimepiride (2-6 mg/die), chosen according to local practice - or pioglitazone (15-45 mg/die). A HbA1c value > 8.0 % on two consecutive occasions will lead to addition of insulin to ongoing oral therapy. Primary efficacy outcome: a composite endpoint of all-cause mortality, non fatal MI (including silent MI), non fatal stroke, and unplanned coronary revascularization. Secondary outcomes. Principal secondary outcome: a composite ischemic endpoint of sudden death, fatal and non fatal acute MI (including silent MI), fatal and non fatal stroke, major amputations (above ankle), endovascular or surgical intervention on the coronary, leg or carotid arteries. Other secondary outcomes - a composite cardiovascular end point including the primary end point plus hospitalization for heart failure, endovascular or surgical intervention on the coronary, leg or carotid arteries, silent MI, angina - by WHO criteria and confirmed by a new electrocardiogram abnormality - intermittent claudication with an ankle/brachial index lower than 090; events of heart failure; a microvascular endpoint including: plasma creatinine increase of 2 times above the baseline value or creatinine clearance reduction of 20ml/min/1. 73m2 or development of overt nephropathy (dialysis or plasma creatinine >3,3 mg/dl) or macroalbuminuria; glycemic control (changes from baseline in HBA1c, time to failure of glycemic control, i.e., HBA1c >8.0% on two consecutive occasions three months apart); major CV risk factors (lipids, blood pressure, microalbuminuria, inflammation markers, waist circumference); safety and side effects; direct and indirect costs. Data regarding CV endpoints, safety, tolerability, and study conduct will be monitored and analyzed by an independent committee, and will be not available to the study investigators until the closing of data collection. Efficacy end points will be analyzed on an intention-to-treat basis.
NCT00700856 ↗ Thiazolidinediones Or Sulphonylureas and Cardiovascular Accidents.Intervention Trial Unknown status Italian Society of Diabetology Phase 4 2008-09-01 Background: In patients with type 2 diabetes inadequately controlled with metformin, two main therapeutic options are equally plausible: add-on a sulfonylurea (SU) or a thiazolidinedione (TZD). Since the two classes of drugs clearly differ in terms of mechanisms of action, side effects, economic costs and cardiovascular risk factors profile, a direct comparison of the two therapeutic strategies would be most appropriate. Aims: 1) To evaluate the effects of add-on pioglitazone as compared with add-on a SU on the incidence of cardiovascular events in type 2 diabetic patients inadequately controlled with metformin; 2) To compare the two treatments in terms of glycemic control, safety, and economic costs. Methods: multicentre, randomised, open label, parallel group trial of 48 months duration. Eligible participants (type 2 diabetic males and females, aged 50-75 years, BMI 20-45 Kg/m2, in treatment for the last two months with metformin 2 gr/die in monotherapy and with HbA1c > =7.0% and <= 9.0%) will be randomized to add-on: a SU - glibenclamide (5-15 mg/die), gliclazide (30-120 mg/die), glimepiride (2-6 mg/die), chosen according to local practice - or pioglitazone (15-45 mg/die). A HbA1c value > 8.0 % on two consecutive occasions will lead to addition of insulin to ongoing oral therapy. Primary efficacy outcome: a composite endpoint of all-cause mortality, non fatal MI (including silent MI), non fatal stroke, and unplanned coronary revascularization. Secondary outcomes. Principal secondary outcome: a composite ischemic endpoint of sudden death, fatal and non fatal acute MI (including silent MI), fatal and non fatal stroke, major amputations (above ankle), endovascular or surgical intervention on the coronary, leg or carotid arteries. Other secondary outcomes - a composite cardiovascular end point including the primary end point plus hospitalization for heart failure, endovascular or surgical intervention on the coronary, leg or carotid arteries, silent MI, angina - by WHO criteria and confirmed by a new electrocardiogram abnormality - intermittent claudication with an ankle/brachial index lower than 090; events of heart failure; a microvascular endpoint including: plasma creatinine increase of 2 times above the baseline value or creatinine clearance reduction of 20ml/min/1. 73m2 or development of overt nephropathy (dialysis or plasma creatinine >3,3 mg/dl) or macroalbuminuria; glycemic control (changes from baseline in HBA1c, time to failure of glycemic control, i.e., HBA1c >8.0% on two consecutive occasions three months apart); major CV risk factors (lipids, blood pressure, microalbuminuria, inflammation markers, waist circumference); safety and side effects; direct and indirect costs. Data regarding CV endpoints, safety, tolerability, and study conduct will be monitored and analyzed by an independent committee, and will be not available to the study investigators until the closing of data collection. Efficacy end points will be analyzed on an intention-to-treat basis.
NCT00722631 ↗ Anti-Inflammatory Effects of Pioglitazone Completed Kurume University N/A 2007-05-01 There is increasing evidence that inflammation plays a role in progression and destabilization of atherosclerotic plaque. FDG-PET can visualize activated metabolic activity of inflammatory cells. It is possible that FDG-PET can detect atherosclerotic plaque inflammation and that FDG-PET can monitor the effect of pioglitazone on plaque inflammation.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

Condition Name

Condition Name for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
Intervention Trials
Type 2 Diabetes Mellitus 6
Diabetes Mellitus 4
Diabetes Mellitus, Type 2 4
Type 2 Diabetes 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
Intervention Trials
Diabetes Mellitus, Type 2 15
Diabetes Mellitus 15
Insulin Resistance 2
Hypertension 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

Trials by Country

Trials by Country for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
Location Trials
United States 127
Germany 32
Canada 12
Italy 10
United Kingdom 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
Location Trials
Florida 4
California 4
Arizona 4
Alabama 4
Illinois 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
Clinical Trial Phase Trials
Phase 4 9
Phase 3 7
N/A 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 14
Unknown status 4
Terminated 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

Sponsor Name

Sponsor Name for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
Sponsor Trials
Takeda 6
IKFE Institute for Clinical Research and Development 2
Kowa Company, Ltd. 1
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
Sponsor Trials
Other 15
Industry 13
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.