Page last updated: 2024-10-28

glipizide and Cardiovascular Diseases

glipizide has been researched along with Cardiovascular Diseases in 9 studies

Glipizide: An oral hypoglycemic agent which is rapidly absorbed and completely metabolized.
glipizide : An N-sulfonylurea that is glyburide in which the (5-chloro-2-methoxybenzoyl group is replaced by a (5-methylpyrazin-2-yl)carbonyl group. An oral hypoglycemic agent, it is used in the treatment of type 2 diabetes mellitus.

Cardiovascular Diseases: Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.

Research Excerpts

Excerpt	Relevance	Reference
"Using nationwide administrative Danish registries, we followed all individuals without prior stroke or myocardial infarction who initiated metformin and an IS from 1997 through 2009."	3.81	Metformin in combination with various insulin secretagogues in type 2 diabetes and associated risk of cardiovascular morbidity and mortality--a retrospective nationwide study. ( Andersson, C; Fosbøl, EL; Gislason, G; Køber, L; Mogensen, UM; Scheller, NM; Schramm, TK; Torp-Pedersen, C; Vaag, A, 2015)
" Adverse events (AE) and hypoglycemia were monitored."	2.79	Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. ( Bryzinski, B; Cook, W; Hirshberg, B; Minervini, G, 2014)
"Glimepiride was associated with the best clinical outcome, showing the lowest mortality and lowest cardiovascular event risk of the five insulin secretagogues."	1.51	Comparison of mortality and cardiovascular event risk associated with various insulin secretagogues: A nationwide real-world analysis. ( Huang, HK; Yeh, JI, 2019)

Research

Studies (9)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	2 (22.22)	18.2507
2000's	0 (0.00)	29.6817
2010's	7 (77.78)	24.3611
2020's	0 (0.00)	2.80

Authors

Authors	Studies
Douros, A	1
Yin, H	1
Yu, OHY	1
Filion, KB	1
Azoulay, L	1
Suissa, S	1
Huang, HK	1
Yeh, JI	1
Del Prato, S	1
Camisasca, R	1
Wilson, C	1
Fleck, P	1
Cook, W	1
Minervini, G	1
Bryzinski, B	1
Hirshberg, B	1
Mogensen, UM	1
Andersson, C	1
Fosbøl, EL	1
Schramm, TK	1
Vaag, A	1
Scheller, NM	1
Torp-Pedersen, C	1
Gislason, G	1
Køber, L	1
Simpson, SH	2
Lee, J	1
Choi, S	1
Vandermeer, B	1
Abdelmoneim, AS	2
Featherstone, TR	1
Hasenbank, SE	1
Seubert, JM	1
Brocks, DR	1
Light, PE	1
Abraira, C	2
Colwell, J	1
Nuttall, F	1
Sawin, CT	1
Henderson, W	1
Comstock, JP	1
Emanuele, NV	1
Levin, SR	1
Pacold, I	1
Lee, HS	1
McGuire, DK	1

Clinical Trials (3)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Ins[NCT00757588]	Phase 3	455 participants (Actual)	Interventional	2008-11-30	Completed
A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylure[NCT00575588]	Phase 3	891 participants (Actual)	Interventional	2007-12-31	Completed
A Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects[NCT00327015]	Phase 3	1,306 participants (Actual)	Interventional	2006-05-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])

Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use (NCT00757588)
Timeframe: Baseline to Week 24

Intervention	Percentage of change (Mean)
Saxagliptin, 5 mg + Insulin	-0.73
Placebo + Insulin	-0.32

Change From Baseline in 120-minute PPG Values During an MTT

An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal. (NCT00757588)
Timeframe: Baseline to Week 24

Intervention	mg/dL (Mean)
Saxagliptin, 5 mg + Insulin	-27.2
Placebo + Insulin	-4.2

Change From Baseline in Fasting Plasma Glucose Values

(NCT00757588)
Timeframe: Baseline to Week 24

Intervention	mg/dL (Mean)
Saxagliptin, 5 mg + Insulin	-10.1
Placebo + Insulin	-6.1

Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF)

Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline. (NCT00757588)
Timeframe: Baseline to Week 24

Intervention	Units (Mean)
Saxagliptin, 5 mg + Insulin	1.71
Placebo + Insulin	5.01

Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT)

Intervention	mg*min/dL (Mean)
Saxagliptin, 5 mg + Insulin	-4548.5
Placebo + Insulin	-718.8

Number of Participants With Abnormal Changes From Baseline in Electrocardiogram (ECG) Results

"ECG abnormalities included those in nonspecific other categories (Other nonspecific ST/T, Other intraventricular conduction defect, Other, and Other rhythm abnormalities)and nonspecific findings, such as sinus bradycardia, sinus arrythmia, sinus tachycardia, poor R-wave progression, and ventricular premature contractions." (NCT00757588)
Timeframe: Baseline to Week 52

Intervention	Participants (Number)
Saxagliptin, 5 mg + Insulin	15
Placebo + Insulin	11

Percentage of Participants Achieving a Therapeutic Glycemic Response

Therapeutic glycemic response is defined as an A1C<7%. Significance was not interpreted with a p value. (NCT00757588)
Timeframe: Baseline to Week 24

Intervention	Percentage of participants (Number)
Saxagliptin, 5 mg + Insulin	17.3
Placebo + Insulin	6.7

Mean Changes From Baseline in Heart Rate

(NCT00757588)
Timeframe: Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52

Intervention	Beats per minute (Number)
	Week 2 (n=294, 147)	Week 4 (n=293, 144)	Week 6 (n=280, 141)	Week 8 (n=290, 142)	Week 12 (n=286, 144)	Week 16 (n=278, 139)	Week 20 (n=276, 137)	Week 24 (n=273, 134)	Week 28 (n=264, 132)	Week 36 (n=261, 129)	Week 44 (n=250, 125)	Week 52 (n=246, 125)
Placebo + Insulin	-0.7	-1.0	-0.9	-0.7	0.2	-0.6	0.4	-1.0	-0.6	-0.0	-0.7	0.2
Saxagliptin, 5 mg + Insulin	-0.5	-0.5	-0.5	-0.0	0.3	-1.0	-0.5	0.0	-1.0	0.0	0.2	-0.3

Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings

(NCT00757588)
Timeframe: Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52

Intervention	mm Hg (Number)
	Systolic blood pressure (Week 2) (n=294, 147)	Systolic blood pressure (Week 4) (n=293, 144)	Systolic blood pressure (Week 6) (n=280, 141)	Systolic blood pressure (Week 8) (n=290, 142)	Systolic blood pressure (Week 12) (n=286, 144)	Systolic blood pressure (Week 16) (n=278, 139)	Systolic blood pressure (Week 20) (n=276, 137)	Systolic blood pressure (Week 24) (n=273, 134)	Systolic blood pressure (Week 28) (n=264, 132)	Systolic blood pressure (Week 36) (n=261, 129)	Systolic blood pressure (Week 44) (n=250, 125)	Systolic blood pressure (Week 52) (n=246, 125)	Diastolic blood pressure (Week 2) (n=294, 147)	Diastolic blood pressure (Week 4) (n=293, 144)	Diastolic blood pressure (Week 6) (n=280, 141)	Diastolic blood pressure (Week 8) (n=290, 142)	Diastolic blood pressure (Week 12) (n=286, 144)	Diastolic blood pressure (Week 16) (n=278, 139)	Diastolic blood pressure (Week 20) (n=276, 137)	Diastolic blood pressure (Week 24) (n=273, 134)	Diastolic blood pressure (Week 28) (n=264, 132)	Diastolic blood pressure (Week 36) (n=261, 129)	Diastolic blood pressure (Week 44) (n=250, 125)	Diastolic blood pressure (Week 52) (n=246, 125)
Placebo + Insulin	2.3	0.0	1.0	2.4	2.2	1.1	1.3	-0.1	1.8	3.6	2.6	1.0	1.4	1.8	0.3	2.1	1.0	1.3	1.1	0.5	0.2	0.2	0.4	0.1
Saxagliptin, 5 mg + Insulin	-1.0	-1.2	-0.8	-0.8	-1.7	-1.2	-0.6	-1.5	-1.4	-0.7	-0.6	0.0	0.1	0.0	0.0	-0.5	-0.8	-1.1	-0.7	-1.7	-1.6	-1.2	-0.3	-0.5

Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs

An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment. (NCT00757588)
Timeframe: Baseline to Week 52, continuously

Intervention	Participants (Number)
	At least 1 AE	At least 1 treatment-related AE	Deaths	At least 1 SAE	At least 1 treatment-related SAE	Discontinuations due to SAEs	Discontinuations due to AEs
Placebo + Insulin	108	34	0	13	0	0	3
Saxagliptin, 5 mg + Insulin	202	56	2	25	3	4	9

Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period

"Marked abnormality=a laboratory value lying outside the predefined criteria and more extreme (farther from the limit)on-treatment than at baseline. ULN=upper limit of normal; LLN=lower limit of normal; prx=pre-RX=pretreatment.~Criteria 1: if prx=0 use >=2, if prx=0.5 or 1 use >=3, if prx=2 use 4." (NCT00757588)
Timeframe: Baseline and during and up to 14 days after last dose of study drug (in Week 52)

Intervention	Participants (Number)
	Hemoglobin <8 g/dL (n=300; 150)	Hematocrit <0.75*prx (n=300; 150)	Platelets <50*10^9 c/L (n=297; 145)	Platelets >1.5*ULN (n=297; 145)	Leukocytes <2*1000 c/uL (n=300; 150)	Neutrophils <1*1000 c/uL (n=296; 150)	Eosinophils >0.9*1000 c/uL (n=296; 150)	Lymphocytes <=0.75*1000 c/uL (n=296; 150)	Alkaline phosphatase >3*prx & >ULN (n=302; 150)	Alkaline phosphatase >1.5 ULN (n=302; 150)	Aspartate aminotransferase >3* ULN (n=298; 148)	Aspartate aminotransferase>5* ULN (n=298; 148)	Aspartate aminotransferase >10*ULN (n=298; 148)	Aspartate aminotransferase >20*ULN (n=298; 148)	Alanine transaminase >3*ULN (n=300; 148)	Alanine transaminase >5*ULN (n=300; 148)	Alanine transaminase >10*ULN (n=300; 148)	Alanine transaminase >20*ULN (n=300; 148)	Bilirubin, total >2 mg/dL (n=301; 150)	Bilirubin, total >1.5*ULN (n=301; 150)	Bilirubin, total >2*ULN (n=301; 150)	Blood urea nitrogen >2*prx & >ULN (n=302; 150)	Creatinine >2.5 mg/dL (n=303; 150)	Glucose, serum fasting <50 mg/dL (n=0; 0)	Glucose, serum fasting >500 mg/dL (n=0; 0)	Glucose, serum unspecified <50 mg/dL (n=0; 0)	Glucose, serum unspecified >500 mg/dL (n=0; 0)	Glucose, plasma fasting <50 mg/dL (n=301;150)	Glucose, plasma fasting >500 mg/dL (n=301;150)	Glucose, plasma unspecified <50 mg/dL (n=272; 133)	Glucose, plasma unspecified >500 mg/d (n=272; 133)	Sodium, serum <0.9*prx & <=130 mEq/L (n=302; 150)	Sodium, serum >1.1*prx & >=150 mEq/L (n=302; 150)	Potassium, serum <0.8 prx &<=3.2 mEq/L(n=300; 148)	Potassium, serum >1.2*prx&>= 6.0 mEq/L(n=300; 148)	Chloride, serum <90 mEq/L (n=302; 150)	Chloride, serum >120 mEq/L (n=302; 150)	Albumin <0.9*LLN; if prx	Creatine kinase >5*ULN (n=301, 148)	Uric acid >1.5*ULN; if prx >ULN, >2 (n=0,0)	Protein urine (see criteria 1) (n=297,146)	Blood urine (see criteria 1) (n=297; 146)	Red blood cells urine (see criteria 1) (n=53; 31)	White blood cells urine (see criteria 1)(n=115;53)
Placebo + Insulin	0	2	0	0	1	0	7	2	1	5	0	0	0	0	3	0	0	0	0	1	0	7	0	0	0	0	0	0	1	1	1	0	0	1	8	0	0	0	2	0	3	2	3	10
Saxagliptin, 5 mg + Insulin	2	2	0	0	0	1	9	3	2	10	2	1	0	0	5	1	0	0	0	0	0	5	0	0	0	0	0	5	0	5	1	1	0	3	8	1	0	1	6	0	8	14	8	35

Percentage of Participants With Reported and Confirmed Hypoglycemia

Confirmed hypoglycemia=fingerstick glucose measurement of ≤50 mg/dL with associated symptoms/ (NCT00757588)
Timeframe: Baseline to Week 52

Intervention	Percentage of Participants (Number)
	Reported	Confirmed
Placebo + Insulin	24.5	6.6
Saxagliptin, 5 mg + Insulin	19.4	7.6

Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)

Absolute lymphocyte count=value*10^3 c/uL (NCT00757588)
Timeframe: Baseline and Weeks 24 and 52

Intervention	Participants (Number)
	Baseline <= 0.75; Week 24 <= 0.75	Baseline <= 0.75; Week 24 >0.75- <= 5.00	Baseline <= 0.75; Week 24 >5.00	Baseline >0.75- <= 5.00; Week 24 <= 0.75	Baseline >0.75- <= 5.00; Week 24 >0.75- <= 5.00	Baseline >0.75- <= 5.00; Week 24 >5.00	Baseline >5.00; Week 24 <= 0.75	Baseline >5.00; Week 24 >0.75- <= 5.00	Baseline >5.00; Week 24 >5.00	Baseline <= 0.75; Week 52 <= 0.75	Baseline <= 0.75; Week 52 >0.75- <= 5.00	Baseline <= 0.75; Week 52 >5.00	Baseline >0.75- <= 5.00; Week 52 <= 0.75	Baseline >0.75- <= 5.00; Week 52 >0.75- <= 5.00	Baseline >0.75- <= 5.00; Week 52 >5.00	Baseline >5.00; Week 52 <= 0.75	Baseline >5.00; Week 52 >0.75- <= 5.00	Baseline >5.00; Week 52 >5.00
Placebo + Insulin	0	2	0	0	148	0	0	0	0	0	2	0	0	147	1	0	0	0
Saxagliptin, 5 mg + Insulin	0	0	0	1	293	1	0	0	1	0	0	0	0	295	0	0	0	1

Shift in Platelet Counts From Baseline to Selected Visits (LOCF)

Platelet count=value*10^9 c/L (NCT00757588)
Timeframe: Baseline and Weeks 24 and 52

Intervention	Participants (Number)
	Baseline <= 100; Week 24 <= 100	Baseline <= 100; Week 24 >100 - <= 600	Baseline <= 100; Week 24 >600	Baseline >100 - <= 600; Week 24 <= 100	Baseline >100 - <= 600; Week 24 >100 - <= 600	Baseline >100 - <= 600; Week 24 >600	Baseline >600; Week 24 <= 100	Baseline >600; Week 24 >100 - <= 600	Baseline >600; Week 24 >600	Baseline <= 100; Week 52 <= 100	Baseline <= 100; Week 52 >100 - <= 600	Baseline <= 100; Week 52 >600	Baseline >100 - <= 600; Week 52 <= 100	Baseline >100 - <= 600; Week 52 >100 - <= 600	Baseline >100 - <= 600; Week 52 >600	Baseline >600; Week 52 <= 100	Baseline >600; Week 52 >100 - <= 600	Baseline >600; Week 52 >600
Placebo + Insulin	0	0	0	1	143	0	0	0	0	0	1	0	0	144	0	0	0	0
Saxagliptin, 5 mg + Insulin	0	0	0	1	296	0	0	0	0	0	0	0	2	295	0	0	0	0

Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c

Mean slopes of regression of change from Week 24 to Week 104 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Full Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect. (NCT00575588)
Timeframe: Week 24 to Week 104

Intervention	Percent (Mean)
Saxagliptin + Metformin	0.0041
Glipizide + Metformin	0.0076

Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c

Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect. (NCT00575588)
Timeframe: Week 24 to Week 52

Intervention	Percent (Mean)
Saxagliptin + Metformin	0.001
Glipizide + Metformin	0.004

Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks

Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 104 weeks (Safety Analysis Set) (NCT00575588)
Timeframe: Baseline, Week 104

Intervention	Percentage of Participants (Number)
Saxagliptin + Metformin	3.5
Glipizide + Metformin	38.4

Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks

Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set) (NCT00575588)
Timeframe: From Baseline to Week 52

Intervention	Percentage of Participants (Number)
Saxagliptin + Metformin	3
Glipizide + Metformin	36.3

Body Weight Change From Baseline to Week 104

Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104. Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value. (NCT00575588)
Timeframe: Baseline, Week 104

Intervention	kilograms (Mean)
	Baseline	Week 104	Adjusted Change from Baseline to Week 104
Glipizide + Metformin	88.57	89.80	1.29
Saxagliptin + Metformin	88.69	87.47	-1.47

Body Weight Change From Baseline to Week 52

Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value. (NCT00575588)
Timeframe: Baseline, Week 52 (Last Observation Carried Forward)

Intervention	kilogram (Mean)
	Baseline	Week 52	Adjusted Change from Baseline to Week 52
Glipizide + Metformin	88.6	89.7	1.1
Saxagliptin + Metformin	88.7	87.6	-1.1

Hemoglobin A1c (HbA1c) Change From Baseline to Week 104

Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value. (NCT00575588)
Timeframe: Baseline, Week 104

Intervention	Percent (Mean)
	Baseline	Week 104	Adjusted Change from Baseline to Week 104
Glipizide + Metformin	7.65	7.27	-0.35
Saxagliptin + Metformin	7.65	7.27	-0.41

Hemoglobin A1c (HbA1c) Change From Baseline to Week 52

Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value. (NCT00575588)
Timeframe: Baseline to 52 Weeks

Intervention	Percent (Mean)
	Baseline	Week 52	Adjusted Change from Baseline to Week 52
Glipizide + Metformin	7.53	6.71	-0.80
Saxagliptin + Metformin	7.46	6.74	-0.74

Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus metformin alone at Week 24. (NCT00327015)
Timeframe: Week 24

Intervention	Percentage of participants (Number)
Saxagliptin 5 mg + Metformin	60.3
Saxagliptin 10 mg + Metformin	59.7
Metformin	41.1

Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24. (NCT00327015)
Timeframe: Week 24

Intervention	Percentage of participants (Number)
Saxagliptin 5 mg + Metformin	60.3
Saxagliptin 10 mg + Metformin	59.7
Saxagliptin 10 mg	32.2

Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus metformin alone at Week 24. (NCT00327015)
Timeframe: Week 24

Intervention	Percentage of participants (Number)
Saxagliptin 5 mg + Metformin	45.3
Saxagliptin 10 mg + Metformin	40.6
Metformin	29.0

Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Percentage of participants achieving A1C ≤6.5%, at each dose of saxagliptin plus metformin versus saxagliptin alone at Week 24. (NCT00327015)
Timeframe: Week 24

Intervention	Percentage of Participants (Number)
Saxagliptin 5 mg + Metformin	45.3
Saxagliptin 10 mg + Metformin	40.6
Saxagliptin 10 mg	20.3

Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Percentage of participants requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24-week treatment period at each dose of saxagliptin plus metformin versus metformin alone. (NCT00327015)
Timeframe: Week 24

Intervention	Percentage of participants (Number)
Saxagliptin 5 mg + Metformin	7.5
Saxagliptin 10 mg + Metformin	5.9
Metformin	10.1

Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Intervention	Percentage of participants (Number)
Saxagliptin 5 mg + Metformin	7.5
Saxagliptin 10 mg + Metformin	5.9
Saxagliptin 10 mg	21.2

Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Mean change from baseline in A1C at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Intervention	percent (Mean)
	Baseline Mean	Week 24 Mean	Adjusted Mean Change from Baseline
Metformin	9.43	7.48	-1.99
Saxagliptin 10 mg + Metformin	9.53	7.02	-2.49
Saxagliptin 5 mg + Metformin	9.41	6.93	-2.53

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Mean change from baseline in FPG at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Intervention	mg/dL (Mean)
	Baseline Mean	Week 24 Mean	Adjusted Mean Change from Baseline
Metformin	199.1	152.7	-47.3
Saxagliptin 10 mg + Metformin	204.3	140.1	-62.2
Saxagliptin 5 mg + Metformin	198.9	140.2	-59.8

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Mean change from baseline in FPG at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Intervention	mg/dL (Mean)
	Baseline Mean	Week 24 Mean	Adjusted Mean Change from Baseline
Saxagliptin 10 mg	200.9	169.9	-30.9
Saxagliptin 10 mg + Metformin	204.3	140.1	-62.2
Saxagliptin 5 mg + Metformin	198.9	140.2	-59.8

Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Mean change from baseline in A1C at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Intervention	percent (Mean)
	Baseline Mean	Week 24 Mean	Adjusted Mean Change from Baseline
Saxagliptin 10 mg	9.61	7.86	-1.69
Saxagliptin 10 mg + Metformin	9.53	7.02	-2.49
Saxagliptin 5 mg + Metformin	9.41	6.93	-2.53

Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy

Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjsuted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Intervention	mg*min/dL (Mean)
	Baseline Mean	Week 24 Mean	Adjusted Mean Change from Baseline
Metformin	57937	42428	-15005
Saxagliptin 10 mg + Metformin	57219	35790	-21336
Saxagliptin 5 mg + Metformin	55531	35324	-21080

Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy

Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value. (NCT00327015)
Timeframe: Baseline, Week 24

Intervention	mg*min/dL (Mean)
	Baseline Mean	Week 24 Mean	Adjusted Mean Change from Baseline
Saxagliptin 10 mg	57584	41229	-16054
Saxagliptin 10 mg + Metformin	57219	35790	-21336
Saxagliptin 5 mg + Metformin	55531	35324	-21080

Reviews

2 reviews available for glipizide and Cardiovascular Diseases

Article	Year
Mortality risk among sulfonylureas: a systematic review and network meta-analysis. The lancet. Diabetes & endocrinology, 2015, Volume: 3, Issue:1 Topics: Aged; Cardiovascular Diseases; Cause of Death; Diabetes Mellitus, Type 2; Female; Glipizide; Humans;	2015
Variations in tissue selectivity amongst insulin secretagogues: a systematic review. Diabetes, obesity & metabolism, 2012, Volume: 14, Issue:2 Topics: Animals; ATP-Binding Cassette Transporters; Carbamates; Cardiovascular Diseases; Cricetinae; Cyclohe	2012

Trials

4 trials available for glipizide and Cardiovascular Diseases

Article	Year
Durability of the efficacy and safety of alogliptin compared with glipizide in type 2 diabetes mellitus: a 2-year study. Diabetes, obesity & metabolism, 2014, Volume: 16, Issue:12 Topics: Adult; Aged; Blood Glucose; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase	2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgraduate medicine, 2014, Volume: 126, Issue:6 Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D	2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgraduate medicine, 2014, Volume: 126, Issue:6 Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D	2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgraduate medicine, 2014, Volume: 126, Issue:6 Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D	2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgraduate medicine, 2014, Volume: 126, Issue:6 Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D	2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgraduate medicine, 2014, Volume: 126, Issue:6 Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D	2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgraduate medicine, 2014, Volume: 126, Issue:6 Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D	2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgraduate medicine, 2014, Volume: 126, Issue:6 Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D	2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgraduate medicine, 2014, Volume: 126, Issue:6 Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D	2014
Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgraduate medicine, 2014, Volume: 126, Issue:6 Topics: Adamantane; Adult; Blood Glucose; Body Weight; Cardiovascular Diseases; Diabetes Mellitus, Type 2; D	2014
Cardiovascular events and correlates in the Veterans Affairs Diabetes Feasibility Trial. Veterans Affairs Cooperative Study on Glycemic Control and Complications in Type II Diabetes. Archives of internal medicine, 1997, Jan-27, Volume: 157, Issue:2 Topics: Aged; Blood Glucose; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Feasibility Studies; Glipiz	1997
Intensive insulin therapy in patients with type 2 diabetes: implications of the Veterans affairs (VA CSDM) feasibility trial. American heart journal, 1999, Volume: 138, Issue:5 Pt 1 Topics: Adult; Aged; Blood Glucose; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Diabetic Nephropathi	1999

Other Studies

3 other studies available for glipizide and Cardiovascular Diseases

Article	Year
Pharmacologic Differences of Sulfonylureas and the Risk of Adverse Cardiovascular and Hypoglycemic Events. Diabetes care, 2017, Volume: 40, Issue:11 Topics: Aged; Aged, 80 and over; Body Mass Index; Cardiovascular Diseases; Cohort Studies; Diabetes Mellitus	2017
Comparison of mortality and cardiovascular event risk associated with various insulin secretagogues: A nationwide real-world analysis. Diabetes research and clinical practice, 2019, Volume: 152 Topics: Aged; Carbamates; Cardiovascular Diseases; Cohort Studies; Diabetes Mellitus, Type 2; Diabetic Angio	2019
Metformin in combination with various insulin secretagogues in type 2 diabetes and associated risk of cardiovascular morbidity and mortality--a retrospective nationwide study. Diabetes research and clinical practice, 2015, Volume: 107, Issue:1 Topics: Aged; Carbamates; Cardiovascular Diseases; Denmark; Diabetes Mellitus, Type 2; Drug Therapy, Combina	2015