Page last updated: 2024-10-27

glimepiride and Cognitive Dysfunction

glimepiride has been researched along with Cognitive Dysfunction in 1 studies

glimepiride: structure given in first source

Cognitive Dysfunction: Diminished or impaired mental and/or intellectual function.

Research Excerpts

Excerpt	Relevance	Reference
" Linagliptin is a glucose-lowering agent of the dipeptidyl peptidase-IV (DPP-IV) inhibitor class that is of particular interest for the prevention of accelerated cognitive decline, because it may potentially benefit the brain through pleiotropic effects, beyond glucose lowering."	5.27	Rationale and design of the CAROLINA® - cognition substudy: a randomised controlled trial on cognitive outcomes of linagliptin versus glimepiride in patients with type 2 diabetes mellitus. ( Biessels, GJ; Espeland, MA; Janssen, J; Johansen, OE; Mattheus, M; van den Berg, E; Zinman, B, 2018)

Research

Studies (1)

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	1 (100.00)	24.3611
2020's	0 (0.00)	2.80

Authors

Authors	Studies
Biessels, GJ	1
Janssen, J	1
van den Berg, E	1
Zinman, B	1
Espeland, MA	1
Mattheus, M	1
Johansen, OE	1

Clinical Trials (1)

Trial Overview

Trial			Phase	Enrollment	Study Type	Start Date	Status
A Multicentre, International, Randomised, Parallel Group, Double Blind Study to Evaluate Cardiovascular Safety of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk.[NCT01243424]			Phase 3	6,103 participants (Actual)	Interventional	2010-11-11	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

CGM Sub-study : Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Millimoles/ Litre) to End of Study

Baseline data for the continuous glucose monitoring sub-study was collected and analyzed. However, the participant number was far less than original planned. The study was stopped early around week 64 (V9) due to recruitment issues and data were not pre-specified to be analyzed and reported at week 64 time point as target was with an estimated time point of 432 weeks for primary or secondary end points. Thus this endpoint was not analysed and only the baseline data collected were analysed and the results are reported in this CGM substudy endpoint. (NCT01243424)
Timeframe: Baseline

Intervention	Millimoles/ Litre (mmol/L) (Mean)
All Participants	2.45

Change From Baseline of Insulin Secretion Rate (ISR) at Fixed Glucose Concentration at 208 Weeks

The endpoint change from baseline of ISR at fixed glucose concentration at 208 weeks as derived from a 3-hour meal tolerance test is Beta-cell function sub-study endpoint. (NCT01243424)
Timeframe: Baseline and week 208

Intervention	Picomol/ minute/meter^2 (pmol/min/m²) (Mean)
Linagliptin	11.07
Glimepiride	6.95

Change From Baseline to Final Visit in Creatinine

Change from baseline to final visit in creatinine is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. (NCT01243424)
Timeframe: Baseline and week 432

Intervention	mg/dL (Least Squares Mean)
Linagliptin	0.08
Glimepiride	0.09

Change From Baseline to Final Visit in Estimated Glomerular Filtration Rate (eGFR)

Change from baseline to final visit in eGFR is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. (NCT01243424)
Timeframe: Baseline and week 432

Intervention	mL/minute/1.73 meter^2 (Least Squares Mean)
Linagliptin	-4.0
Glimepiride	-5.0

Change From Baseline to Final Visit in Fasting Plasma Glucose (FPG)

Change from baseline to final visit in fasting plasma glucose (FPG) is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. (NCT01243424)
Timeframe: Baseline and week 432

Intervention	Milligram/ deciliter (mg/dL) (Least Squares Mean)
Linagliptin	12.4
Glimepiride	19.7

Change From Baseline to Final Visit in Hemoglobin A1c (HbA1c)

Change from baseline to final visit in HbA1c is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. (NCT01243424)
Timeframe: Baseline and week 432

Intervention	Percentage glycosylated hemoglobin (%) (Least Squares Mean)
Linagliptin	0.06
Glimepiride	0.15

Change From Baseline to Final Visit in Triglycerides

Change from baseline to final visit in triglycerides is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. (NCT01243424)
Timeframe: Baseline and week 432

Intervention	mg/dL (Least Squares Mean)
Linagliptin	1.7
Glimepiride	5.2

Change From Baseline to Final Visit in Urine Albumin Creatinine Ratio (UACR)

Change from baseline to final visit in UACR is presented as secondary diabetes-related endpoint. Least square mean is adjusted geometric mean (gMean) ratio. The Final Visit value referred to the last value obtained on-treatment. (NCT01243424)
Timeframe: Baseline and week 432

Intervention	mg/ gcrea (Geometric Mean)
Linagliptin	1.52
Glimepiride	1.57

Continuous Glucose Monitoring (CGM) Sub-study: Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Milligrams/ Deciliter) to End of Study

Intervention	Milligrams/ deciliter (mg/ dL) (Mean)
All Participants	44.2

Percentage of Participants Taking Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, Without >2% Weight Gain, and Without Moderate/Severe Hypoglycaemic Episodes During Maintenance Phase

The second key secondary endpoint was a composite endpoint of treatment sustainability, defined as the percentage of patients taking trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, without >2% weight gain, and without moderate/severe hypoglycaemic episodes during maintenance phase. (NCT01243424)
Timeframe: From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase)

Intervention	Percentage of participants (%) (Number)
Linagliptin	16.0
Glimepiride	10.2

Percentage of Participants Who Were on Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, and Without >2% Weight Gain During Maintenance Phase

The third key secondary endpoint was a composite endpoint of treatment sustainability, defined as percentage of patients who were on trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, and without >2% weight gain during maintenance phase. (NCT01243424)
Timeframe: From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase)

Intervention	Percentage of participants (%) (Number)
Linagliptin	17.4
Glimepiride	14.1

Percentage of Participants With Occurrence of Accelerated Cognitive Decline at End of Follow-up

Occurrence of accelerated cognitive decline based on regression based index (RBI) score at end of follow-up (a dichotomous outcome measure; presence or absence of accelerated cognitive decline) is Cognition sub-study endpoint. (NCT01243424)
Timeframe: 433 weeks

Intervention	Percentage of participants (%) (Number)
Linagliptin	27.8
Glimepiride	27.6

Percentage of Participants With Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events

"Percentage of participants with occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of:~CV death (including fatal stroke and fatal MI)~non-fatal MI~non-fatal stroke~hospitalisation for unstable angina pectoris~TIA~hospitalisation for heart failure~hospitalisation for coronary revascularisation procedures (CABG, PCI)" (NCT01243424)
Timeframe: From start of the treatment until 7 days after the end of treatment, up to 433 weeks

Intervention	Percentage of participants (%) (Number)
Linagliptin	17.1
Glimepiride	17.8

Percentage of Participants With the Occurrence of at Least One Event of 3P-MACE

Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI) and non-fatal stroke is presented as secondary CV endpoint. (NCT01243424)
Timeframe: From randomization until individual day of trial completion, up to 432 weeks

Intervention	Percentage of participants (%) (Number)
Linagliptin	11.8
Glimepiride	12.0

Percentage of Participants With the Occurrence of at Least One Event of 4P -MACE

Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI), non-fatal stroke, and hospitalisation for unstable angina pectoris is presented as secondary CV endpoint. (NCT01243424)
Timeframe: From randomization until individual day of trial completion, up to 432 weeks

Intervention	Percentage of participants (%) (Number)
Linagliptin	13.2
Glimepiride	13.3

The First 3-point Major Adverse Cardiovascular Events (3P-MACE)

The first occurrence of any of the following Clinical Event Committee (CEC) confirmed adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), or nonfatal stroke is presented. (NCT01243424)
Timeframe: From randomization until individual day of trial completion, up to 432 weeks

Intervention	Events/ 1000 patients-years (Number)
Linagliptin	20.7
Glimepiride	21.2

The First 4-point (4P)- MACE

The first key secondary endpoint was time to first occurrence of any of the following adjudicated components of the composite endpoint: CV death (including fatal stroke and fatal MI), non-fatal stroke, non-fatal MI (excluding silent MI), or hospitalisation for unstable angina pectoris. (NCT01243424)
Timeframe: From randomization until individual day of trial completion, up to 432 weeks

Intervention	Events/ 1000 patients-years (Number)
Linagliptin	23.4
Glimepiride	23.7

Time to First Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events

"Time to first occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of:~CV death (including fatal stroke and fatal MI)~non-fatal MI~non-fatal stroke~hospitalisation for unstable angina pectoris~Transient ischaemic attack (TIA)~hospitalisation for heart failure~hospitalisation for coronary revascularisation procedures (CABG, PCI)" (NCT01243424)
Timeframe: From start of the treatment until 7 days after the end of treatment, up to 433 weeks

Intervention	Events/ 1000 patients-years (Number)
Linagliptin	31.1
Glimepiride	32.4

Change From Baseline to Final Visit Fasting Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol and High-density Lipoprotein (HDL) Cholesterol

Change from baseline to final visit in total cholesterol, low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment. (NCT01243424)
Timeframe: Baseline and week 432

Intervention	mg/dL (Least Squares Mean)
	LDL cholesterol	HDL cholesterol	Total cholesterol
Glimepiride	-6.5	0.3	-0.5
Linagliptin	-6.1	0.7	-5.4

Percentage of Participants With Transition in Albuminuria Classes

Percentage of patients with transition in albuminuria classes is presented as secondary endpoint. Data for last value on treatment (LVOT) to baseline (base) is presented. (NCT01243424)
Timeframe: Baseline and week 432

Intervention	Percentage of participants (%) (Number)
	Base (<30mg/gcrea) LVOT (<30mg/gcrea)	Base(<30mg/gcrea)LVOT(>=30 to<=300mg/gcrea)	Base (<30 mg/gcrea) LVOT (>300 mg/gcrea)	Base (>=30 to <=300 mg/gcrea) LVOT(<30mg/gcrea)	Base(>=30to<=300mg/gcrea)LVOT(>=30to<=300mg/gcrea)	Base (>=30 to <=300 mg/gcrea) LVOT(>300 mg/gcrea)	Base (>300 mg/gcrea) LVOT (<30 mg/gcrea)	Base (>300 mg/gcrea) LVOT(>=30 to<=300mg/gcrea)	Base (>300 mg/gcrea) LVOT(>300 mg/gcrea)
Glimepiride	57.7	16.0	1.4	5.1	12.1	3.7	0.3	0.9	2.7
Linagliptin	58.4	14.1	1.4	5.4	12.7	3.5	0.1	0.8	3.4

Trials

1 trial available for glimepiride and Cognitive Dysfunction

Article	Year
Rationale and design of the CAROLINA® - cognition substudy: a randomised controlled trial on cognitive outcomes of linagliptin versus glimepiride in patients with type 2 diabetes mellitus. BMC neurology, 2018, Jan-15, Volume: 18, Issue:1 Topics: Aged; Cognitive Dysfunction; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Humans; Hypogly	2018