EVALUATION OF GLYCEMIC RESPONSE OF ADDITION OF PIOGLITAZONE TO GLIBENCLAMIDE AND METFORMIN HCL IN TYPE 2 DIABETIC PATIENTS ON COMPARISON WITH GLIBENCLAMIDE AND METFORMIN MONOTHERAPY
Retrospective study of Antidiabetic drugs in Diabetes Mellitus patients. It help in for Pharmacy graduates, Pharm D Students, M Pharm -pharmacy practice students , hospital pharmacists & Clinical Pharmacists around the globe.
DIABETES IS A PROGRESSIV DISEASE AND WE NEED TO STAY ONE STEP AHEAD OF THE DISEASE.WE HAVE TO TITRATE THE MEDICATIONS EVERY THREE MONTHS AND THE TIME IS NOT OUR FRIEND AS FAR AS THE MANAGEMENT OF DIABETES IS CONCERNED
Interested in learning more about Metformin, here's all you need to know!
Brought to you by the MedSimple Team.
MedSimple is a unified medication management platform designed to help patients two or more meds through the following features:
• 1. A Med List to document prescribed and over-the-counter medications, dosage, frequency and strength
• 2. A customizable list of prescribers and pharmacies
• 3. Cost savings via coupons (Premium feature)
• 4. Generic Alternatives: Links to information about generic alternatives, fixed price (such as $4) lists
• 5. Long-term cost savings via Patient Assistance Programs and forms for requesting assistance (Premium feature)
• 6. Dosage reminders (such as alarms and notifications)
• 7. Refill reminders for picking up prescriptions prior to refill dates (Premium feature)
• 8. Drug information and complete look-up on drug side affects, interactions, warnings and more
• 9. Ready-to-use digital MedSimple Drug Discount Card
• 10. Access to and synchronized data with browser-based partner site, MedSimpleApp.com
ABSTRACT
Over the last decade, diabetes mellitus has emerged as an important clinical and public health
problem throughout the world. The aim of the study is perceive the Potentiality of a newer oral
Antihyperglycemic combination therapy over conventional therapy in type 2 diabetes. The
prospective study was conducted over a period of six months in the department of Medicine,
Guntur City Hospital. The prevalence of type2 diabetes was high in male 65.79 % than female
34.21%. Majority of the patients (23.68 %) belonged to age group of 51–55 years. Majority of
patients (55.26%) having a family history of Diabetes. Majority of patients receiving Combination
of Glibenclamide + Metformin (60.53%), evaluated for effect on FPG for both combinations. The
mean changes in FPG were noted. In the same way effect on HbA1c also noted. Mean changes in
for every month HbA1c will be noted. Our study reveals that Combination therapy with Metformin
plus Glimepiride is more effective than Glibenclamide plus Metformin; in improving glycemic
control in type 2 diabetes, while also allowing a reduction of the dosage of each drug.
Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Diabetes mellitus, or simply diabetes, is a group of metabolic diseases in which a person has high blood sugar, either because the pancreas does not produce enough insulin, or because cells do not respond to the insulin that is produced. The term diabetes is from the Greek word diabaineine refers a tubular organ that take-in or expels water-excessive urine discharges. In 1675, Thomas Willis added mellitus (means ―honey in Latin) to the word diabetes and called it as Diabetes Mellitus, which refers to too much of sweet taste urine. This high blood sugar produces the classical symptoms of polyuria (frequent urination), polydipsia (increased thirst) and polyphagia (increased hunger). Diabetes mellitus is a disorder of glucose regulation, characterized by an accumulating glucose concentration in the blood (Wilkins and Atanasov, 1996).
DIABETES IS A PROGRESSIV DISEASE AND WE NEED TO STAY ONE STEP AHEAD OF THE DISEASE.WE HAVE TO TITRATE THE MEDICATIONS EVERY THREE MONTHS AND THE TIME IS NOT OUR FRIEND AS FAR AS THE MANAGEMENT OF DIABETES IS CONCERNED
Interested in learning more about Metformin, here's all you need to know!
Brought to you by the MedSimple Team.
MedSimple is a unified medication management platform designed to help patients two or more meds through the following features:
• 1. A Med List to document prescribed and over-the-counter medications, dosage, frequency and strength
• 2. A customizable list of prescribers and pharmacies
• 3. Cost savings via coupons (Premium feature)
• 4. Generic Alternatives: Links to information about generic alternatives, fixed price (such as $4) lists
• 5. Long-term cost savings via Patient Assistance Programs and forms for requesting assistance (Premium feature)
• 6. Dosage reminders (such as alarms and notifications)
• 7. Refill reminders for picking up prescriptions prior to refill dates (Premium feature)
• 8. Drug information and complete look-up on drug side affects, interactions, warnings and more
• 9. Ready-to-use digital MedSimple Drug Discount Card
• 10. Access to and synchronized data with browser-based partner site, MedSimpleApp.com
ABSTRACT
Over the last decade, diabetes mellitus has emerged as an important clinical and public health
problem throughout the world. The aim of the study is perceive the Potentiality of a newer oral
Antihyperglycemic combination therapy over conventional therapy in type 2 diabetes. The
prospective study was conducted over a period of six months in the department of Medicine,
Guntur City Hospital. The prevalence of type2 diabetes was high in male 65.79 % than female
34.21%. Majority of the patients (23.68 %) belonged to age group of 51–55 years. Majority of
patients (55.26%) having a family history of Diabetes. Majority of patients receiving Combination
of Glibenclamide + Metformin (60.53%), evaluated for effect on FPG for both combinations. The
mean changes in FPG were noted. In the same way effect on HbA1c also noted. Mean changes in
for every month HbA1c will be noted. Our study reveals that Combination therapy with Metformin
plus Glimepiride is more effective than Glibenclamide plus Metformin; in improving glycemic
control in type 2 diabetes, while also allowing a reduction of the dosage of each drug.
Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Diabetes mellitus, or simply diabetes, is a group of metabolic diseases in which a person has high blood sugar, either because the pancreas does not produce enough insulin, or because cells do not respond to the insulin that is produced. The term diabetes is from the Greek word diabaineine refers a tubular organ that take-in or expels water-excessive urine discharges. In 1675, Thomas Willis added mellitus (means ―honey in Latin) to the word diabetes and called it as Diabetes Mellitus, which refers to too much of sweet taste urine. This high blood sugar produces the classical symptoms of polyuria (frequent urination), polydipsia (increased thirst) and polyphagia (increased hunger). Diabetes mellitus is a disorder of glucose regulation, characterized by an accumulating glucose concentration in the blood (Wilkins and Atanasov, 1996).
Dipeptidyl peptidase inhibitors(DPP-IV): A deep insightRxVichuZ
This presentation deals with DPP-IV inhibitors, that are implicated for use in diabetes mellitus. Generalized pharmacology, including a precise insight into individual drugs have been elucidated.
On DPP-Inhibitor ,case study on Linagliptin,Safe and affective class of drug for Management of Type II Diabetes as Monotherapy and add on therapy with OHA and Insulin,It can be added to SGLT2 Inhibitor also.
Dpp4i vs sglt2 inhibitors against the motionSujoy Majumdar
A debate showing why SGLT2 inhibitors have not have a major advantage over DPP4 inhibitors as the next add on drug after Metformin in the management of Type 2 Diabetes
Complementary and Alternative Medicine in Association with Type 2 Diabetes Me...PranatiChavan
Type 2 Diabetes Mellitus is a clinical condition that is associated with energy metabolism, particularly carbohydrate and fat management in the organism. An increase in the prevalence of diabetic population and the association of decreasing patient compliance and medication adherence leads to prefer a new concept for the management of disease complications.
The use of complementary and alternative medicine (CAM) has proved to be effective for controlling diabetes.
Objectives: The purpose of this review is to perform an overview of CAM use, to emphasize its importance for managing diabetic complications and to get outfits of CAM.
Discussion: A literature survey was done by using various articles related to CAM and Diabetes mellitus. The focus was kept on
the frequency of CAM use, the methods they use, the factors related to the use of CAM, the sources of information about CAM
treatment, and the effect of the method used for disease management.
Conclusion: This review concluded that CAM therapy found to have adept at reducing blood glucose, maintaining a healthy
body, and relieving symptoms of DM. From the study, the relevance of CAM for managing Diabetic complications was verified
And the future need to perform scientific researches on CAM use was analyzed.
SGLT2 Inhibitors v Sitagliptin (SITA) as Add-on Therapy to Metformin Chris Sevald, PhD
SGLT2 inhibitors are the latest class of FDA-approved oral therapies to lower blood glucose in type-2 diabetes.Systematic review and meta-analysis to compare glucose-lowering and weight-loss effects of SGLT2s vs. the most-prescribed DPP-4 inhibitor, SITA. Poster presented at the 21st annual meeting of ISPOR, May, 2016, in Washington DC.
Ketoconazole 200 mg tablets smpc taj pharmaceuticalsTaj Pharma
Ketoconazole Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Ketoconazole Dosage & Rx Info | Ketoconazole Uses, Side Effects -: Indications, Side Effects, Warnings, Ketoconazole - Drug Information - Taj Pharma, Ketoconazole dose Taj pharmaceuticals Ketoconazole interactions, Taj Pharmaceutical Ketoconazole contraindications, Ketoconazole price, Ketoconazole Taj Pharma Ketoconazole 200 mg tablets SMPC- Taj Pharma . Stay connected to all updated on Ketoconazole Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Dipeptidyl peptidase inhibitors(DPP-IV): A deep insightRxVichuZ
This presentation deals with DPP-IV inhibitors, that are implicated for use in diabetes mellitus. Generalized pharmacology, including a precise insight into individual drugs have been elucidated.
On DPP-Inhibitor ,case study on Linagliptin,Safe and affective class of drug for Management of Type II Diabetes as Monotherapy and add on therapy with OHA and Insulin,It can be added to SGLT2 Inhibitor also.
Dpp4i vs sglt2 inhibitors against the motionSujoy Majumdar
A debate showing why SGLT2 inhibitors have not have a major advantage over DPP4 inhibitors as the next add on drug after Metformin in the management of Type 2 Diabetes
Complementary and Alternative Medicine in Association with Type 2 Diabetes Me...PranatiChavan
Type 2 Diabetes Mellitus is a clinical condition that is associated with energy metabolism, particularly carbohydrate and fat management in the organism. An increase in the prevalence of diabetic population and the association of decreasing patient compliance and medication adherence leads to prefer a new concept for the management of disease complications.
The use of complementary and alternative medicine (CAM) has proved to be effective for controlling diabetes.
Objectives: The purpose of this review is to perform an overview of CAM use, to emphasize its importance for managing diabetic complications and to get outfits of CAM.
Discussion: A literature survey was done by using various articles related to CAM and Diabetes mellitus. The focus was kept on
the frequency of CAM use, the methods they use, the factors related to the use of CAM, the sources of information about CAM
treatment, and the effect of the method used for disease management.
Conclusion: This review concluded that CAM therapy found to have adept at reducing blood glucose, maintaining a healthy
body, and relieving symptoms of DM. From the study, the relevance of CAM for managing Diabetic complications was verified
And the future need to perform scientific researches on CAM use was analyzed.
SGLT2 Inhibitors v Sitagliptin (SITA) as Add-on Therapy to Metformin Chris Sevald, PhD
SGLT2 inhibitors are the latest class of FDA-approved oral therapies to lower blood glucose in type-2 diabetes.Systematic review and meta-analysis to compare glucose-lowering and weight-loss effects of SGLT2s vs. the most-prescribed DPP-4 inhibitor, SITA. Poster presented at the 21st annual meeting of ISPOR, May, 2016, in Washington DC.
Ketoconazole 200 mg tablets smpc taj pharmaceuticalsTaj Pharma
Ketoconazole Taj Pharma : Uses, Side Effects, Interactions, Pictures, Warnings, Ketoconazole Dosage & Rx Info | Ketoconazole Uses, Side Effects -: Indications, Side Effects, Warnings, Ketoconazole - Drug Information - Taj Pharma, Ketoconazole dose Taj pharmaceuticals Ketoconazole interactions, Taj Pharmaceutical Ketoconazole contraindications, Ketoconazole price, Ketoconazole Taj Pharma Ketoconazole 200 mg tablets SMPC- Taj Pharma . Stay connected to all updated on Ketoconazole Taj Pharmaceuticals Taj pharmaceuticals Hyderabad.
Presentatie die gebruikt is door Guido Petit van Alcatel - Lucent tijdens de Vision Meeting 'Intrapeneurship: wat leert ons de praktijk?'.
Bron: Alcatal - Lucent | Guido Petit
Its a theoretical content for Pharmacy graduates, post graduates in pharmacy and Doctor of Pharmacy And also M Sc Instrumentation, UG and PG of Ayurveda medical students, MS etc.
Slide Presentation
Diabetes Melliuts Type 2 management basics are life style modifications followed by use of Metformin
What is the best and safest next pharmacologic choice
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EVALUATION OF GLYCEMIC RESPONSE OF ADDITION OF PIOGLITAZONE TO GLIBENCLAMIDE AND METFORMIN HCL IN TYPE 2 DIABETIC PATIENTS ON COMPARISON WITH GLIBENCLAMIDE AND METFORMIN MONOTHERAPY
1. EVALUATION OF GLYCEMIC RESPONSE OF ADDITION OF PIOGLITAZONE TO
GLIBENCLAMIDE AND METFORMIN HCL IN TYPE 2 DIABETIC PATIENTS ON COMPARISON WITH
GLIBENCLAMIDE AND METFORMIN MONOTHERAPY
A Dissertation Submitted
to
SRI VENKATESWARA UNIVERSITY,TIRUPATHI
In partial fulfillment for the award of degree in
MASTER OF PHARMACY
PHARMACOLOGY
By
D.SUKANYA
Reg; No.2800762009
Under the Guidance
Sri K V GOPINATH
PHARMACY DIVISION
SRI VENKATESWARA UNIVERSITY
TIRUPATI- 517502,(A.P),INDIA
APRIL - 2008
3. Aim of the work
To evaluate and compare the therapeutic response of
pioglitazone with glibenclamide and metformin vis-à-
vis the individual effects of each of these hypoglycemic
agents .
4. Objective of the work
To evaluate the effects of the combination of pioglitazone with
glibenclamide and metformin vis-à-vis the individual effects of
each of these hypoglycemic agents.
To compare the therapeutic efficacy or effect of the above
combination with metformin and its rational combinations
(retrospectively)
To evaluate the possible best combination for managing diabetes
in standard care patients.
To monitor adverse drug reactions.
To evaluate the diabetic complications.
To evaluate the etiology of diabetics.
To calculate the Body Mass Index (BMI) as per the NIH software
and interpret with diabetes mellitus.
To collect the demographic data based on One Touch Software.
5. Design of study
parallel case study design & retrospective study
Study Criteria
Inclusion criteria
The following categories of diabetic patients were included in the study.
Patients belonging to Type 2 diabetes using pioglitazone, glibenclamide and
metformin Hydrochloride, and its rationale combinations.
Body mass index > 23 and ≤ 45
Systolic B.P ≤160 mm Hg and diastolic pressure ≤100 mm Hg.
Hemoglobin > 12g/dl for males and > 10 g/dl for females.
Serum creatinine < 1.5mg/dl for males and <1.4 mg/dl for female.
Alanine aminotransferase ≤ 2.5x upper limit of normal.
6. Thyroid-stimulating hormone levels ≤ the upper limit of the normal range and
the subject is clinically euthyroid
No major illness or debility that in the investigators opinion prohibits the
subject from completing the study.
Patients of age group 12 to 60 and above
Patients who were willing to go for glucometer tests and related procedures.
No use of oral or systemically injected glucocorticoids or use of weight loss
drug is allowed within the three months prior to randomization.
Patients who are able to sign written informed consent.
7. Exclusion criteria
Patients with chronic diseases like tuberculosis, severe heart diseases,
aspiration pneumonia, chronic obstructive pulmonary disease (COPD), and
cystic fibrosis.
History of psychiatric disorder that will affect the subject’s ability to participate
in the study.
History of alcohol or substance abuse within the 2 years prior to screening.
Hypersensitivity to any of the drug or its combinations under study.
Patient who are less than 90%compliant in drug usage.
Voluntary withdrawal
Pregnant women and children
8. The study has been divided into phases.
Patients having clinical symptoms of diabetes.
Review inclusion/exclusion criteria
Diabetic diagnosis on basis of glucometer test (fasting and post prandial)
Prescribing anti-diabetic drugs.
Signing consent form by the patient.
Designing of a standard data collection form to collect demographic data of
the patient (Annexure-I) or by using One Touch Software.
Check patient’s Glucometer test.
Assessment of outcome variables by standard statistical analysis.
9. Materials & Methodology
Study Site
The study was conducted at TTD central hospital, Tirupati, Andhra Pradesh.
Sample Size
Total 36 patients were screened and enrolled in the study, but only 15 diabetic
patients were satisfying the inclusion criteria
Drugs
Glibenclamide, Metformin, pioglitazone
10. Drug profiles
Glibenclamide
Systematic (IUPAC) name: 5-chloro-N-[2-[4-(cyclohexylcarbamoylsulfamoyl) phenyl]ethyl]-2-
methoxy-benzamide
Chemical data
Formula: C23H28ClN3O5S
Mol. mass: 494.004 g/mol
Pharmacokinetic data
Protein binding: Extensive
Metabolism: Hepatic hydroxylation (CYP2C9-mediated)
Half life: 10 hours
Excretion: Renal and biliary
Therapeutic considerations
Routes :Oral
Dose: 1.25mg,2.5mg,and 5mg
Trade names: Daonil, Euglucon.
Mechanism of action:“ inhibiting ATP-sensitive potassium channels in pancreatic beta cells”.
11. Metformin
Systematic (IUPAC) name: N,N-dimethylimidodicarbonimidic diamide
Chemical data
Formula:C4H11N5
Mol. mass:129.164 g/mol,165.63 g/mol (hydrochloride)
Trade names: Glucophage, Riomet, Fortamet, Glumetza, Diabex, Diaformin,
Pharmacodynamic data
Bioavailability:50 to 60% under fasting conditions
Half life:6.2 hours
Excretion: Active renal tubular excretion by OCT2
Therapeutic considerations
Routes: Oral
12. pioglitazone
Systematic (IUPAC) name: 5-((4-(2-(5-ethyl-2-pyridinyl)
ethoxy)phenyl)methyl)-,(+-)-2,4-thiazolidinedione
Chemical data
Formula:C19H20N2O3S
Mol. mass: 356.44 g/mol
Brand name: Actos,Glustin
Pharmacokinetic data
Protein binding:>99%
Metabolism:liver (CYP2C8)
Half life: 3–7 hours
Excretion:in bile
Routes: oral
13. Instruments
Glucometer (Life Scan, INC, Milpitas, CA 95035, USA, made in China),
hemocytometer,
six-channel ECG machine,
sphygmomanometer, and
UV spectrophotometer
Duration of Study
6 months
Main Sources of Data
Patient interview
Patient case notes
Personnel medication record
Glucometer tests results
14. Methodology
Patients giving informed consent and satisfying the inclusion criteria will be included in
the study.
They will undergo glucometer tests, pre and post prandial sugar level to confirm the
diabetic, by comparing with normal blood sugar level and also other related procedures
as specified in the inclusive criteria to screen the patients for the study.
A fasting sugar level was measured at 8 AM of the day of testing, with 10 hr gap of the
overnight dinner meal and postprandial administration of glucometer.
The blood sugar readings were noted along with normal diet and anti diabetic drug doses
prescribed by the physician.
The outcome variables measured were noted. The results will be documented in a form.
Patients were given anti diabetic drugs like metformin (M) alone in a 15 number of
diabetic patients for a period of 45 days continuous therapy at a rational drug dose.
The same treatment was discontinued on the 46 th day and kept those people in
observation for 15 days without any antidiabetic as a wash out period and started the
second trail viz glibenclamide (GLIBEN) alone on 61 day and continued the same
procedure for 45 days from the day of second trail, and also tried with pioglitazone along
with glibenclamide plus metformin (P-GLIBEN-M) rational combination on 121 th day
and followed the same procedure.
Glucometers were calibrated daily and therapeutic response of the anti diabetic drug(s)
under trial was noted every day in all patients while in sitting position.
15. DM HT TB Epilepsy Asthma
DM &
HT
Miscellaneous Total
320 234 5 14 147 175 237 1132
Tab 1. Number of Diseases
16. Fig I. Number of Diseases
5
14
147
175
237
1132
234
320
0
200
400
600
800
1000
1200
DM
HT
TB
Epilepsy
Asthma
DM&HT
Miscellaneous
Total
Name of the Disease
NumberofPatients
18. Fig 2. Demographic Data Based on Sex
(n=320)
155
165
320
0
50
100
150
200
250
300
350
Male Female Total
Sex
PercentageofPatients
19. Age in
years 20-29 30-39 40-49 50-59 >60
Number
of Patients
2 17 71 101 129
Tab 3.Demographic Data Based on Age
20. Fig 3. Demographic Data Based on Age
(n=320)
2
17
71
101
129
0
20
40
60
80
100
120
140
20-29 30-39 40-49 50-59 >60
Age in Years
%ofPatients
21. Tab 4. Demographic Data Based on Education
Education Illiterates Middle School High School College Higher
Number of
Patients
103 73 77 57 19
22. Fig 4.Demographic Data Based on Education
(n=320)
103
73
77
57
19
0
20
40
60
80
100
120
Illeterates Middle School High School College Higher
Education
%ofPatients
29. Tab 8. % Change of glycemic value of per oral Anti Diabetics drug(s)
(N=15)
Drug
Mean Baseline
FBS
(mg/dl)
Mean Base line
PPBS
(mg/dl)
Mean Follow-up
FBS
(mg/dl)
Mean Follow up
PPBS
(mg/dl)
Mean%
Change
FBS
(mg/dl)
Mean%
Chan
gePP
BS
(mg/
dl)
M alone 168.25+3.35 230.75+32.54 54.5+34.35 210.5+5.04 22.61 31.56
Gliben
alone
168.25+3.35 230.75+32.54 142.2+3.33 198.9+3.0 12.85 24.31
P +
GLI
BEN
+ M
168.25+3.35 230.75+32.54 120+0.1 174+17 -4.76 8.75
Retrospective study
Met +
Pioz
+
Acar
110 172 94 160 -25.396 0
Met +
Pioz
+
glimipride
153 150 138 115 -8.8235 -39.133
30. Fig:9 Pharmacodynamic response of Metformin HCl
alone
126
168.25
154.4160
230.75
210.5
0
50
100
150
200
250
normal base line the response
Blood sugar parameters
GlycemicResponse(mg/dl)
fbs
ppbs
31. Fig:10 Pharmacodynamic response of Glibenclamide HCl
alone
126
168.25
142.2
160
230.75
198.9
0
50
100
150
200
250
normal base line the.response
Blood sugar parameters
GlycemicResponse(mg/dl)
fbs
ppbs
32. Fig:11 Pharmacodynamic response of
P+Glibenclamide+Met
126
168.25
120
160
230.75
174
0
50
100
150
200
250
normal base line the.response
Blood sugar parameters
Glycemic
Response(mg/dl)
fbs
ppbs
38. Conclusion
It was concluded that the addition of pioglitazone to metformin plus
glibenclamide in Type 2 diabetic patients inadequately controlled by
metformin alone resulted in superior glycemic control compared with
glibenclamide or metformin monotherapy have a complementary mechanisms
of action.
It was also concluded that Glimepride, pioglitazone and metformin or
Acarbose, pioglitazone and metformin have a complementary mechanisms of
action combination therapy with these agents result in improved glycemic
control and improved tolerability at lower doses of individual agents
(retrospective study).
It was also shown that oral antidaibetic drug combination therapy will also
postpone the usage of parenteral insulin therapy.
Diabetes is more common in overweight or obese persons.
Finally it was conclude that, right diagnosis of diabetes, a rationale
combination of right oral anti diabetic drugs, changes in diet and lifestyle
makes to achieve good glycemic control.
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