glimepiride and Dyslipidemias studies

Dyslipidemias: Abnormalities in the serum levels of LIPIDS, including overproduction or deficiency. Abnormal serum lipid profiles may include high total CHOLESTEROL, high TRIGLYCERIDES, low HIGH DENSITY LIPOPROTEIN CHOLESTEROL, and elevated LOW DENSITY LIPOPROTEIN CHOLESTEROL.

Research Excerpts

Excerpt	Relevance	Reference
"Dyslipidemia in patients with type 2 diabetes is characterized by elevated triglyceride levels, decreased high-density lipoprotein (HDL) cholesterol, and a predominance of small dense low-density lipoprotein (LDL) particles."	6.76	PIOfix-study: effects of pioglitazone/metformin fixed combination in comparison with a combination of metformin with glimepiride on diabetic dyslipidemia. ( Forst, T; Fuchs, W; Lehmann, U; Lobmann, R; Merke, J; Müller, J; Pfützner, A; Schöndorf, T; Tschöpe, D, 2011)
"In participants with type 2 diabetes, the incidences of microvascular complications and death were not materially different among the four treatment groups."	3.11	Glycemia Reduction in Type 2 Diabetes - Microvascular and Cardiovascular Outcomes. ( Bebu, I; Burch, HB; Buse, JB; Cherrington, AL; Fortmann, SP; Green, JB; Kahn, SE; Kirkman, MS; Krause-Steinrauf, H; Lachin, JM; Larkin, ME; Nathan, DM; Phillips, LS; Pop-Busui, R; Steffes, M; Tiktin, M; Tripputi, M; Wexler, DJ; Younes, N, 2022)
"Dyslipidemia in patients with type 2 diabetes is characterized by elevated triglyceride levels, decreased high-density lipoprotein (HDL) cholesterol, and a predominance of small dense low-density lipoprotein (LDL) particles."	2.76	PIOfix-study: effects of pioglitazone/metformin fixed combination in comparison with a combination of metformin with glimepiride on diabetic dyslipidemia. ( Forst, T; Fuchs, W; Lehmann, U; Lobmann, R; Merke, J; Müller, J; Pfützner, A; Schöndorf, T; Tschöpe, D, 2011)

Research

Studies (4)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Change From Baseline in Adiponectin.

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	3 (75.00)	24.3611
2020's	1 (25.00)	2.80

Authors	Studies
Nathan, DM	1
Lachin, JM	1
Bebu, I	1
Burch, HB	1
Buse, JB	1
Cherrington, AL	1
Fortmann, SP	1
Green, JB	1
Kahn, SE	1
Kirkman, MS	1
Krause-Steinrauf, H	1
Larkin, ME	1
Phillips, LS	1
Pop-Busui, R	1
Steffes, M	1
Tiktin, M	1
Tripputi, M	1
Wexler, DJ	1
Younes, N	1
Arayne, MS	1
Sultana, N	1
Tabassum, A	1
Hung, YC	1
Lin, CC	1
Wang, TY	1
Chang, MP	1
Sung, FC	1
Chen, CC	1
Pfützner, A	1
Schöndorf, T	1
Tschöpe, D	1
Lobmann, R	1
Merke, J	1
Müller, J	1
Lehmann, U	1
Fuchs, W	1
Forst, T	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study[NCT01794143]	Phase 3	5,047 participants (Actual)	Interventional	2013-05-31	Completed
Effects of a Pioglitazone/Metformin Fixed Combination in Comparison to Metformin in Combination With Glimepiride on Diabetic Dyslipidemia[NCT00770653]	Phase 3	305 participants (Actual)	Interventional	2007-04-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

The change between Adiponectin collected at week 24 or final visit and Adiponectin collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Diastolic Blood Pressure.

Intervention	μg/mL (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	6.79
Glimepiride 2 mg and Metformin 850 mg BID	0.72

The change between Diastolic Blood Pressure measured at week 24 or final visit and Diastolic Blood Pressure measured at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in E-Selectin.

Intervention	mmHg (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	-1.3
Glimepiride 2 mg and Metformin 850 mg BID	-0.1

The change between the value of E-Selectin collected at week 24 or final visit and E-Selectin collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Erythrocyte Deformability (0.30%).

Intervention	ng/mL (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	-3.7
Glimepiride 2 mg and Metformin 850 mg BID	-0.5

The change between the 0.30 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Erythrocyte Deformability (0.60%)

Intervention	percent (Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	1.3
Glimepiride 2 mg and Metformin 850 mg BID	-0.4

The change between the 0.60 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Erythrocyte Deformability (1.20).

Intervention	percent (Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	2.4
Glimepiride 2 mg and Metformin 850 mg BID	-0.5

The change between the 1.20 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Erythrocyte Deformability (12.00).

Intervention	percent (Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	3.2
Glimepiride 2 mg and Metformin 850 mg BID	-1.1

The change between the 12.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Erythrocyte Deformability (3.00).

Intervention	percent (Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	2.7
Glimepiride 2 mg and Metformin 850 mg BID	-1.3

The change between the 3.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Erythrocyte Deformability (30.00).

Intervention	percent (Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	3.3
Glimepiride 2 mg and Metformin 850 mg BID	-.15

The change between the 30.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Erythrocyte Deformability (6.00).

Intervention	percent (Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	2.5
Glimepiride 2 mg and Metformin 850 mg BID	-1.3

The change between the 6.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Erythrocyte Deformability (60.00).

Intervention	percent (Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	3.1
Glimepiride 2 mg and Metformin 850 mg BID	-1.4

The change between the 60.00 percent value of Erythrocyte (Red Blood Cell) Deformability collected at week 24 or final visit and Erythrocyte Deformability collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Fasting Glucose.

Intervention	percent (Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	2.7
Glimepiride 2 mg and Metformin 850 mg BID	-1.3

The change between Fasting Glucose collected at week 24 or final visit and Fasting Glucose collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Fasting Intact Proinsulin.

Intervention	mg/dL (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	-21.6
Glimepiride 2 mg and Metformin 850 mg BID	-21.1

The change between Fasting Intact Proinsulin collected at week 24 or final visit and Fasting Intact Proinsulin collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Glycosylated Hemoglobin.

Intervention	pmol/L (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	-5.18
Glimepiride 2 mg and Metformin 850 mg BID	-0.11

The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or final visit and Glycosylated Hemoglobin collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in High Sensitivity C-reactive Protein (≤ 10 mg/L).

Intervention	mg/dL (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	-0.83
Glimepiride 2 mg and Metformin 850 mg BID	-0.95

The change between the value of High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at week 24 or final visit and High Sensitivity C-reactive Protein less than or equal to 10 mg/L collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in High Sensitivity C-reactive Protein (Original).

Intervention	mg/L (Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	-0.87
Glimepiride 2 mg and Metformin 850 mg BID	0.00

The change between the value of High Sensitivity C-reactive Protein collected at week 24 or final visit and High Sensitivity C-reactive Protein collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in High-Density Lipoprotein Cholesterol.

Intervention	mg/L (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	-0.21
Glimepiride 2 mg and Metformin 850 mg BID	-0.04

The change between HDL-Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in High-Density Lipoprotein/Low-Density Lipoprotein Ratio.

Intervention	mg/dL (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	3.3
Glimepiride 2 mg and Metformin 850 mg BID	-0.4

The change between High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at week 24 or final visit and High-Density Lipoprotein/Low-Density Lipoprotein Ratio collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Low-Density Lipoprotein Cholesterol.

Intervention	mg/dL (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	0.1
Glimepiride 2 mg and Metformin 850 mg BID	0.3

The change between Low-Density Lipoprotein Cholesterol collected at week 24 or final visit and Low-Density Lipoprotein Cholesterol collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Low-Density Lipoprotein Subfractions.

Intervention	mg/dL (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	9.7
Glimepiride 2 mg and Metformin 850 mg BID	11.2

The change between the value of Low-Density Lipoprotein Subfractions collected at week 24 or final visit and Low-Density Lipoprotein Subfractions collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Matrix Metallo Proteinase-9.

Intervention	mg/dL (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	6.2
Glimepiride 2 mg and Metformin 850 mg BID	6.1

The change between the value of Baseline in Matrix Metallo Proteinase-9 collected at week 24 or final visit and Baseline in Matrix Metallo Proteinase-9 collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Nitrotyrosine.

Intervention	ng/mL (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	31.4
Glimepiride 2 mg and Metformin 850 mg BID	51.6

The change between the value of Nitrotyrosine collected at week 24 or final visit and Nitrotyrosine collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Platelet Function.

Intervention	nmol/L (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	-2.7
Glimepiride 2 mg and Metformin 850 mg BID	32.5

The change between the value of Platelet Function by PFA 100 collected at week 24 or final visit and Platelet Function by PFA 100 collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Soluble CD40 Ligand.

Intervention	sec (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	-30.3
Glimepiride 2 mg and Metformin 850 mg BID	-1.0

The change between the value of Soluble CD40 Ligand collected at week 24 or final visit and Soluble CD40 Ligand collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Soluble Intracellular Adhesion Molecule.

Intervention	pg/mL (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	-40.7
Glimepiride 2 mg and Metformin 850 mg BID	102.4

The change between the value of Baseline in Soluble Intracellular Adhesion molecule at week 24 or final visit and Baseline in Soluble Intracellular Adhesion molecule collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Soluble Vascular Cell Adhesion Molecule.

Intervention	ng/mL (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	-13.0
Glimepiride 2 mg and Metformin 850 mg BID	-3.2

The change between the value of Soluble Vascular Cell Adhesion Molecule collected at week 24 or final visit and Soluble Vascular Cell Adhesion Molecule collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Systolic Blood Pressure.

Intervention	ng/mL (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	11.6
Glimepiride 2 mg and Metformin 850 mg BID	3.3

The change between Systolic Blood Pressure measured at week 24 or final visit and Systolic Blood Pressure measured at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Thromboxane B2.

Intervention	mmHg (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	-2.5
Glimepiride 2 mg and Metformin 850 mg BID	0.5

The change between the value of Thromboxane B2 collected at week 24 or final visit and Thromboxane B2 collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Triglycerides.

Intervention	pg/mL (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	-216.4
Glimepiride 2 mg and Metformin 850 mg BID	527.8

The change between the value of Triglycerides collected at week 24 or final visit and Triglycerides collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Change From Baseline in Von-Willebrand Factor.

Intervention	mg/dL (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	-40.9
Glimepiride 2 mg and Metformin 850 mg BID	-16.7

The change between the value of Von-Willebrand Factor collected at week 24 or final visit and Von-Willebrand Factor collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Intake of Study Medication Greater Than 80% and Less Than 120%.

Intervention	percent (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	-19.5
Glimepiride 2 mg and Metformin 850 mg BID	1.4

The change between the Intake of study medication greater than 80% at week 24 or final visit and Baseline and the Intake of study medication greater than 80% at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

The Mean Increase From Baseline in High-Density Lipoprotein Cholesterol.

Intervention	participants (Number)
Pioglitazone 15 mg and Metformin 850 mg BID	136
Glimepiride 2 mg and Metformin 850 mg BID	137

The increase in High-Density Lipoprotein (HDL) Cholesterol collected at week 24 or final visit and HDL-Cholesterol collected at baseline. (NCT00770653)
Timeframe: Baseline and Week 24.

Article	Year
Glycemia Reduction in Type 2 Diabetes - Microvascular and Cardiovascular Outcomes. The New England journal of medicine, 2022, 09-22, Volume: 387, Issue:12 Topics: Albuminuria; Blood Glucose; Cardiovascular Diseases; Comparative Effectiveness Research; Diabetes Co	2022
PIOfix-study: effects of pioglitazone/metformin fixed combination in comparison with a combination of metformin with glimepiride on diabetic dyslipidemia. Diabetes technology & therapeutics, 2011, Volume: 13, Issue:6 Topics: Adiponectin; Aged; Anticholesteremic Agents; C-Reactive Protein; Cholesterol, HDL; Cholesterol, LDL;	2011

Intervention	mg/dL (Least Squares Mean)
Pioglitazone 15 mg and Metformin 850 mg BID	3.2
Glimepiride 2 mg and Metformin 850 mg BID	-0.3

glimepiride and Dyslipidemias