Intensification Options after basal Insulin RevisitedUsama Ragab
Intensification Options revisited
By Dr. Usama Ragab Youssif
Add an OAD
Add a short-acting insulin at mealtime
Switch to premixed insulins
Novel insulin combinations
Basal insulin/GLP-1 RA combinations
MFLN Nutrition and Wellness New Medications for Type 2 Diabetesmilfamln
Do your patients manage their diabetes by eating well and being active? Or do they need medication to help control their blood sugar? What medications are the most effective and what is new to the market? Tune in to this webinar to guide you through what is available and most effective to help your patients better control their type 2 diabetes.
Learning Objectives:
1. Understand the current paradigm for the treatment of type 2 diabetes.
2. Compare and contrast pros and cons of newer medications for the Treatment of type 2 diabetes.
3. Modify a treatment plan correctly and efficiently based on the side effect profiles of newer medications for the treatment of type 2 diabetes.
Materi Workshop Diabetes Melitus untuk Dokter Umum - Practical Management of ...Dayu Agung Dewi Sawitri
Materi Workshop Diabetes Melitus untuk Dokter Umum - Practical Management of Diabetes and Its Complication for General Practitioner.
Diselenggarakan oleh Perkeni, Kementerian Kesehatan RI dan STENO Diabetes Center
Background
No previous studies have compared the DPP-4 inhibitors vildagliptin and sitagliptin in terms of blood glucose levels using continuous glucose monitoring (CGM) and cardiovascular parameters.
Methods
Twenty patients with type 2 diabetes mellitus were randomly allocated to groups who received vildagliptin then sitagliptin, or vice versa. Patients were hospitalized at 1 month after starting each drug, and CGM was used to determine: 1) mean (± standard deviation) 24-hour blood glucose level, 2) mean amplitude of glycemic excursions (MAGE), 3) fasting blood glucose level, 4) highest postprandial blood glucose level and time, 5) increase in blood glucose level after each meal, 6) area under the curve (AUC) for blood glucose level ≥180 mg/dL within 3 hours after each meal, and 7) area over the curve (AOC) for daily blood glucose level <70 mg/dL. Plasma glycosylated hemoglobin (HbA1c), glycoalbumin (GA), 1,5-anhydroglucitol (1,5AG), immunoreactive insulin (IRI), C-peptide immunoreactivity (CPR), brain natriuretic peptide (BNP), and plasminogen activator inhibitor-1 (PAI-1) levels, and urinary CPR levels, were measured.
Results
The mean 24-hour blood glucose level was significantly lower in patients taking vildagliptin than sitagliptin (142.1 ± 35.5 vs. 153.2 ± 37.0 mg/dL; p = 0.012). In patients taking vildagliptin, MAGE was significantly lower (110.5 ± 33.5 vs. 129.4 ± 45.1 mg/dL; p = 0.040), the highest blood glucose level after supper was significantly lower (206.1 ± 40.2 vs. 223.2 ± 43.5 mg/dL; p = 0.015), the AUC (≥180 mg/dL) within 3 h was significantly lower after breakfast (484.3 vs. 897.9 mg/min/dL; p = 0.025), and urinary CPR level was significantly higher (97.0 ± 41.6 vs. 85.2 ± 39.9 μg/day; p = 0.008) than in patients taking sitagliptin. There were no significant differences in plasma HbA1c, GA, 1,5AG, IRI, CPR, BNP, or PAI-1 levels between patients taking vildagliptin and sitagliptin.
Conclusions
CGM showed that mean 24-h blood glucose, MAGE, highest blood glucose level after supper, and hyperglycemia after breakfast were significantly lower in patients with type 2 diabetes mellitus taking vildagliptin than those taking sitagliptin. There were no significant differences in BNP and PAI-1 levels between patients taking vildagliptin and sitagliptin
Intensification Options after basal Insulin RevisitedUsama Ragab
Intensification Options revisited
By Dr. Usama Ragab Youssif
Add an OAD
Add a short-acting insulin at mealtime
Switch to premixed insulins
Novel insulin combinations
Basal insulin/GLP-1 RA combinations
MFLN Nutrition and Wellness New Medications for Type 2 Diabetesmilfamln
Do your patients manage their diabetes by eating well and being active? Or do they need medication to help control their blood sugar? What medications are the most effective and what is new to the market? Tune in to this webinar to guide you through what is available and most effective to help your patients better control their type 2 diabetes.
Learning Objectives:
1. Understand the current paradigm for the treatment of type 2 diabetes.
2. Compare and contrast pros and cons of newer medications for the Treatment of type 2 diabetes.
3. Modify a treatment plan correctly and efficiently based on the side effect profiles of newer medications for the treatment of type 2 diabetes.
Materi Workshop Diabetes Melitus untuk Dokter Umum - Practical Management of ...Dayu Agung Dewi Sawitri
Materi Workshop Diabetes Melitus untuk Dokter Umum - Practical Management of Diabetes and Its Complication for General Practitioner.
Diselenggarakan oleh Perkeni, Kementerian Kesehatan RI dan STENO Diabetes Center
Background
No previous studies have compared the DPP-4 inhibitors vildagliptin and sitagliptin in terms of blood glucose levels using continuous glucose monitoring (CGM) and cardiovascular parameters.
Methods
Twenty patients with type 2 diabetes mellitus were randomly allocated to groups who received vildagliptin then sitagliptin, or vice versa. Patients were hospitalized at 1 month after starting each drug, and CGM was used to determine: 1) mean (± standard deviation) 24-hour blood glucose level, 2) mean amplitude of glycemic excursions (MAGE), 3) fasting blood glucose level, 4) highest postprandial blood glucose level and time, 5) increase in blood glucose level after each meal, 6) area under the curve (AUC) for blood glucose level ≥180 mg/dL within 3 hours after each meal, and 7) area over the curve (AOC) for daily blood glucose level <70 mg/dL. Plasma glycosylated hemoglobin (HbA1c), glycoalbumin (GA), 1,5-anhydroglucitol (1,5AG), immunoreactive insulin (IRI), C-peptide immunoreactivity (CPR), brain natriuretic peptide (BNP), and plasminogen activator inhibitor-1 (PAI-1) levels, and urinary CPR levels, were measured.
Results
The mean 24-hour blood glucose level was significantly lower in patients taking vildagliptin than sitagliptin (142.1 ± 35.5 vs. 153.2 ± 37.0 mg/dL; p = 0.012). In patients taking vildagliptin, MAGE was significantly lower (110.5 ± 33.5 vs. 129.4 ± 45.1 mg/dL; p = 0.040), the highest blood glucose level after supper was significantly lower (206.1 ± 40.2 vs. 223.2 ± 43.5 mg/dL; p = 0.015), the AUC (≥180 mg/dL) within 3 h was significantly lower after breakfast (484.3 vs. 897.9 mg/min/dL; p = 0.025), and urinary CPR level was significantly higher (97.0 ± 41.6 vs. 85.2 ± 39.9 μg/day; p = 0.008) than in patients taking sitagliptin. There were no significant differences in plasma HbA1c, GA, 1,5AG, IRI, CPR, BNP, or PAI-1 levels between patients taking vildagliptin and sitagliptin.
Conclusions
CGM showed that mean 24-h blood glucose, MAGE, highest blood glucose level after supper, and hyperglycemia after breakfast were significantly lower in patients with type 2 diabetes mellitus taking vildagliptin than those taking sitagliptin. There were no significant differences in BNP and PAI-1 levels between patients taking vildagliptin and sitagliptin
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
1. ‘Glaritus’
Insulin Glargine
The True Basal 24 Hour Long Acting Insulin
Santi Syafril
Endocrine Metabolic and Diabetes Division, Internal Medicine Department,
◦ Adam Malik Hospital Medan / FK-USU
S
A
V
E
U
PT
O
30%
WH
Y
O
UU
P
G
R
A
D
E
T
O
A
IM
A
G
E
P
A
C
K
Save Now
2. Diabetes Mellitus Problems in Indonesia
• Diabetes Mellitus prevalence is
increase
AMPUTASI
PENYAKIT
JANTUNG
KEBUTAAN GAGAL
GINJAL
• Glycemic target achievement is low
• Increase diabetic
complications will increase
health cost burden
4. 7
IDF Atlas 2021
Top 10 countries or territories for number of adults
(20-79 years with diabetes in 2021 and 2045
5. RISKESDAS 2018: Diabetes Prevalence
in Indonesia 10.9%1
1. Kementerian Kesehatan. Riset Kesehatan Dasar 2018.
Prevalens
i DM
menurut
Konsensu
s Perkeni
2011
pada
penduduk
umur ≥
15 tahun
0
2
4
6
8
10
12
2007
2013
2018
1.5 2.4
1.5
4.2 4.5
9.4
5.7 6.9
10.9
D-DM UD-DM T-DM
In 2018: 86%
Undiagnosed diabetic patients
7. Mayority type 2 Diabetics in Asia-Pacific
failed to achieve glycemic target (HbA1c <
7%)
Hong Kong
(Diab Registry6)
S. Korea
(KNHANES8)
43.5%
56.5%
Australia
(St
Vincent’s1)
China
(Diabcare7)
41.1%
58.9%
India
(DEDICOM4)
37
.8
62
.2
37.8%
62.2%
Thailand
(Diab Registry2)
30.2%
69.8%
Singapore
(Diabcare3)
33.0%
67.0%
39.7%
60.3%
70.0%
30.0%
HbA1c at or
below target
HbA1c above target
1.Bryant W, et al. MJA 2006;185:305–9. 2. Kosachunhanun N, et al. J Med Assoc Thai 2006;89:S66–71
3. Lee WRW, et al. Singapore Med J 2001;42:501–7. 4. Nagpal J & Bhartia A. Diabetes Care 2006;29:2341–8
5. Soewondo P, et al. Med J Indoes 2010;19:235–44. 6. Tong PCY, et al. Diab Res Clin Pract 2008;82:346–52
7. Pan C, et al. Curr Med Res Opin 2009;25:39–45. 8. Choi YJ, et al. Diabetes Care 2009;32:2016–20.
9. Mafauzy M, et al. Med J Malaysia 2011;66:175–81.
10. Jimeno CA, Sobrepena L, Mirasol R. Phil. Journal of Int Med 2012; 50 (1):15-22
22.0%
78.0%
Malaysia
(DiabCare9)
32.1%
67.9%
Indonesia
(Diabcare5)
Philippines
(DiabCare10)
85.0%
15.0%
8. Poor Glycemic Control in Type 2 Diabetics
in Indonesia
More than 70% patients in Indonesia not achieved glycemic control target
<7%
7-9.9%
>10% 28.3%
43.5%
28.2%
HbA1C Achievement
Soetedjo et al,
2018.
n=783
Soetedjo et al, Trop Med and Int Health. 2018 (23): 1118-1128
10. Prevalence of type 2 Diabetes complications
in Indonesia in 2016
Hidayat et al, Value Health Reg Issues. 2022; 28:82–89
11. Uncontrolled diabetes mellitus will increase
diabetic complications and future increase
health cost burden1
(Liebl et al. Kosten des Typ-e-Diabetes in Deutschland. DMW 2001; 126(20): 588)
Total diabetic cost depend on complication
Incrased 2.4
fold
Increased 2.5
fold
Increased 4.1
fold
Diabetes without
complication
Diabetes with
microvaskular
complications
Diabetes with
macrovaskular
complications
Diabetes with
micro and macrovaskular
complications
12. Only 1% decrease of HbA1c will decrease
long term diabetic complications1
1. Stratton IM et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS
35): prospective observational study. BMJ. 2000;321(7258):405-412.
43%
Amputation
37%
Microvaskular
complications
19%
Catarac
extraction
14%
Miokard
infarct
16%
Heart
failure
12%
Stroke
13. What is clinical inertia?
Clinical inertia may mean different things to
different people……..
In essence clinical inertia may be considered as
a delay or failure to initiate or escalate therapy
and may lead to clinical and economic
implications
14. Earlier and appropriate intervention may
improve patients’ chances of reaching goal
HbA1c, glycated haemoglobin; OAD, oral antidiabetic medication
Adapted from: Khunti K, et al. Diab Care 2013;36:3411–7; Del Prato S, et al. Int J Clin Pract 2005;59:1345–1355
HbA
1c
Time
OAD
monotherapy
OAD triple
combination
OAD dual
combination Insulin
Conventional stepwise
treatment approach
Earlier and more aggressive
intervention approach
10
9
8
7
6
8.7% 9.1% 9.7%
8.5%
For all patients
2.9 years 7.2 years 6.7 years
8.4% 8.8% 9.0%
For those with
HbA1c ≥7%
15. Insulin is the most effective choice in
decreasing blood glucose
Nathan et al., Diabetes Care 2009;32:193-203.
Decreasing HbA1c: Monotherapy potency
Early insulinization for better effectivity
16. Rationale for early initiation of insulin
1
2
3
4
5
Owens et al, Diabetes Technol Ther. 2013 Sep; 15(9): 776–785.
Overcoming the glucotoxic effects of
hyperglycemia
Facilitating “β-cell rest,” and
preserving β-cell mass and function
Improves insulin sensitivity
Long term protection to end organs
Avoid prolonged glycemic burden and
alters disease progression
52% diabetic patients
had complication at
diagnosis1
2 of 3 patients were
uncontrolled even
with treatment2
17. Time of day (hours)
400
300
200
100
0
6 6
10 14 18 22 2
Plasma
glucose
(mg/dl)
Normal
Meal Meal Meal
20
15
10
5
0
Plasma
glucose
(mmol/l)
Hyperglycaemia due to an increase in fasting glucose
T2DM
Why initiation with Basal Insulin?
Decreased (fasting/basal) blood glucose
will decreased whole blood glucose profile
24 hours1
1. Adapted from Polonsky K, et al. N Engl J Med 1988;318:1231―1239. 2. Riddle MC et al. Diabetes 2010; 59 (Suppl. 1) :A171
24% 22% 21% 21% 20%
76% 78% 79% 79% 80%
0
20
40
60
80
100
Fasting hyperglycaemia
Postprandial hyperglycaemia
In OAD therapy, fasting
hyperglycemia, contributes more
to increased HbA1C2
18. Why are Basal insulin levels so
important?
Physiological Basal insulin 0.5 – 1.0 U/Hour.
The main function of basal insulin is to
regulate basal hepatic glucose
production in the fasting state and
between meals or snacks.
REGULATES FASTING PLASMA
GLUCOSE
(Diabetes Care 2002;25:395-6.)
19. Ideal Basal Insulin
The ideal basal insulin should..…
Mimic the physiological Insulin secretion pattern
Have square-wave action profile, i.e., no peak, long-lasting
Have reproducible effects
Have pharmacodynamic effects similar to pump insulin
This need is fulfilled by:
INSULIN GLARGINE
21. Insulin glargine provides a reliable,
constant basal insulin concentration to
control basal metabolism with one injection
daily
22. Production of Glargine
Using a non pathogenic superior strain of Escherichia
coli by a Recombinant DNA technology
23. Provides
stability at
acidic pH
Shifts isoelectric
point from pH 5.4 to
6.7; Makes the
molecule soluble at
slightly acidic pH &
less soluble at
physiologic pH
Development of Glargine
(How is it different from human insulin?)
Altered pharmacokinetics of Glargine
24. Mechanism of action of Glargine
Clear Solution
pH4
Precipitation
Dissolution
Capillary Membrane
Insulin in Blood
Hexamers Dimers Monomers
24
pH 7.4
Injection of an acidic
solution (pH 4.0)
Precipitation of glargine
in subcutaneous tissue
(pH 7.4)
Slow dissolution of free
glargine hexamers from
precipitated glargine
(stabilized aggregates)
Delayed Absorption
Prolonged action
25. Drug Concentration Levels of Glargine
Glargine
• Onset of action – app 1-2 hrs
• Duration of action- 24 hours…A flat insulin profile
between 1 and 24 hours…A constant basal insulin supply
for 24 hours with no pronounced peak Peakless) …24
hour glycaemic control…can be taken at any time of the
day… Meal INDEPENDENT
• Constant release with no pronounced peak
(peakles)…Minimal hypoglycaemia
26. Achievement of Target HbA1c
Proportion Of Patients Achieving Target Hba1c <7%
N=2938
27. Reduction in Hypoglycemia
N=2938
Insulin glargine vs.
comparator in patients aged
<65 years and ≥65 years.
Conclusion:
Analysis by therapy demonstrates that insulin glargine is associated with better glycemic control
and a reduced incidence of daytime and any hypoglycemia in both younger and older T2DM
patients than comparators
Incidence of hypoglycemia
28. Variable Time of Administration
Screening phase
Week – 4 to
Week –1
Week 0
(baseline)
Week 24
(endpoint)
Titration/treatment phase
2 days
Observation
*Insulin glargine titration target: FBG 4.4-6.6 mmol/L (80-120 mg/dL) in the screening phase.
†Lispro was individually titrated and injected before or immediately after a meal.
FBG, fasting blood glucose.
Insulin glargine* prebreakfast + mealtime lispro† (n=121)
Insulin glargine* predinner + mealtime lispro† (n=128)
Insulin glargine* bedtime + mealtime lispro† (n=129)
Type 1 DM
n=378
Hamann A et al. Diabetes. 2002;51(suppl 2):A53. Abstract 215.
29. Glargine: Flexible Dosing Time
Type 1 DM
Hamann A et al. Diabetes. 2002;51(suppl 2):A53. Abstract 215.
Endpoint HbA1c
0
1
2
3
4
5
6
7
8
9
Treatment group
HbA
1c
(%)
Breakfast Dinner Bedtime
(n=121) (n=128) (n=129)
29
30. Favourable Weight Profile
Adapted from Dreyer M. Poster presented at: American Diabetes Association 62nd Scientific Sessions; June 14-18, 2002; San
Francisco, Calif.
Basal/bolus therapy with insulin Glargine:
Minimal effect on weight gain
Time (months)
30 33 Endpoint
Baseline
65
70
75
Weight
(kg)
6 18 24
Type 1 DM
30
32. What are biosimilars?
Legally approved subsequent versions of innovator
biopharmaceutical products made by a different
sponsor following patent & exclusivity expiry of the
innovator product
• Because of structural & manufacturing complexities,
these biological products are considered as similar,
but not generic equivalents of innovator
biopharmaceuticals
33. Biosimilar insulins (BIs)
BIs like Insulin Glargine are as effective and safe as the
originator insulins
Heinemann, Journal of Diabetes Science and Technology 2014, Vol. 8(1) 6– 13
34. Mean Plasma Glargine Concentration vs. Time by Formulation
Biosimilar Insulin glargine - PK
38. Switch from NPH to Glaritus
NPH once daily: Initiate glargine at same dosage;
titrate appropriately
NPH twice daily: Initiate glargine at 20% reduced dose
of total daily IU of NPH
S.N. Switch from NPH Glargine Dose
1 NPH insulin once daily 1.0 x NPH insulin dose
2 NPH insulin twice daily 0.8 x NPH insulin dose
39. Switch from Premixed to Glaritus
Premixed once daily: Initiate glargine at same dosage as
NPH; titrate appropriately
Premixed twice daily: Initiate glargine at 20% reduced
dose of total daily IU of NPH component
S.N
.
Switch from premixed Glargine Dose
1 Premixed (30/70 or 25/75) insulin OD 0.7 x Premixed insulin dose
2 Premixed (30/70 or 25/75) insulin BD 0.56 x Premixed insulin dose
3 Premixed (50/50) insulin OD 0.5 x Premixed insulin dose
4 Premixed (50/50) insulin BD 0.4 x Premixed insulin dose
40. Titrating Glaritus
Most FPG readings over past
three to seven days (mg/dl)
Insulin adjustment
>= 180 Increase by 6 units
140 to 179 Increase by 4 Units
110 to 139 Increase by 2 units
80 to 109 No change
Less than 80 Decrease
42. GLARITUS Study
Safety & Efficacy of Glaritus® Versus Lantus® in
Indian Patients with Type 1 Diabetes Mellitus
• Non-inferiority in glycemic control
Primary
Objective
• Change in blood glucose levels
• Change in glargine dose
• Immunogenic response
• Subjects with hypoglycemia episodes
• Subjects’ safety
Secondary
Objectives
Prospective Randomized Multicenter Comparative
Non-
inferiority
Open Label Parallel
N=161 (Glaritus86/Lantus 85); 14 Centers; Duration: 12 Weeks
43. Results: Efficacy
43
JAFES 2014;29(2):207
Glaritus (n=81)
Lantus (n=77)
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
Glaritus Lantus
0.69
0.53
Mean
decrease
in
HbA1c
levels
Decrease in HbA1c levels from baseline
P=0.454
Difference of adjusted means of change in HbA1c was 0.20 (<USFDA
specified non-inferiority margin of 0.4*)
*Ref: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071624.pdf
44. Results: Efficacy
10/3/2023
JAFES 2014;29(2):207
44
0
1
2
3
4
5
6
7
8
9
Glaritus Lantus
8.81
5.28
Mean
decrease
in
blood
glucose
levels
(mg/dL)
Decrease in blood glucose
levels from baseline
P=0.792
0
10
20
30
40
50
60
70
No Change >10% Increase >10% Decrease
69.1
23.5
7.4
63.6
27.3
9.1
Percentage
of
patients
Change in glargine dose
Patients with change in glargine dose from
baseline
P=0.5
Glaritus (n=81)
Lantus (n=77)
45. Results: Safety
10/3/2023
JAFES 2014;29(2):207
45
Parameter Glaritus (n=81) Lantus (n=77) P Value
Immunogenic
Response*
Mean ± S.D.95% C.I.
0.25 ± 0.97
-0.04, 0.37
0.02 ± 0.68
-0.18, 0.22
0.306
No. of subjects with
hypoglycemic episode
22 (27.2%) 22 (28.6%) 0.843
Adverse Events Glaritus (n=86) Lantus (n=85)
No. of Subjects 9 (10.5%) 12 (14.1%)
No. of Events 10 14
Study results are comparably similar for Glaritus and Lantus
arm
* Assessed by change in serum anti-insulin antibody (AIA) levels from baseline
46. Conclusion of this Study
10/3/2023
JAFES 2014;29(2):207
46
Glaritus® is Safe,
Effective, & Comparable
to Lantus®
47. Important Notes
Glaritus should NOT be administered
intravenously
Glaritus should NOT be mixed with any other
insulin product or diluted with any solution.
Glaritus should not be used to treat diabetic
ketoacidosis
48. Dosage In Special Populations:
Condition Glaritus Dose
Dosage in Renal Failure
No Studies conducted
The dosage of Glaritus may be
less in this population
Careful glucose monitoring is
necessary in these patients
Dosage in Hepatic Insufficiency
49. Dosage In Special Populations:
Glaritus in Pregnancy & Lactation
U.S. Food and Drug Administration's Pregnancy
Category: Category C (All Trimesters)
Drugs should be given only if the potential benefit justifies the
potential risk to the fetus.
Infant risk cannot be ruled out
50. Dosage In Special Populations
Paediatric population
Insulin glargine may be used for children who are 6
years or older
It has NOT been studied in children younger than 6
years of age.
50
51. Say YES to Control…… With GLARITUS
ONE shot a day
No worries about Meal timings
Minimal Hypoglycaemia
LIFESTYLE FLEXIBILITY…
52. Pasien diabetes melitus tipe 2
1
Belum terkontrol dengan
kombinasi metformin dosis optimal & OAD lain
HbA1c > 7.5%
Rerata gula darah 169 mg/dl
Pasien diabetes melitus tipe 2
2
HbA1c > 9%
Gejala dekompensasi metabolik
Pemberian insulin pada (1) dan (2) dapat dilanjutkan untuk pasien diabetes melitus tipe 2, jika insulin
dibutuhkan untuk mempertahankan pengendalian glukosa darah.
3
Inisiasi insulin basal dan premix
FORNAS terbaru berlaku 1 Januari 2022
UPDATE
TERBARU!
53. Dalam FORNAS terbaru,
disebutkan bahwa Dokter di
Faskes Tk.1 dapat melakukan
penyesuaian dosis hingga 20
IU/hari.
Penyesuaian dosis insulin hingga 20 IU/hari oleh
Dokter FKTP
FORNAS terbaru berlaku 1 Januari 2022
KMK No.HK 01.07/MENKES/6485/2021 tentang Formularium Nasional
54. Summary
Clinical inertia is a real issue, with hypoglycaemia a
major barrier to glycaemic goal achievement
Treatment paradigms in diabetes are shifting toward
earlier intervention
Insulin represents a therapeutic mainstay
On-going developments in insulin pharmacology aimed at
optimising the use of exogenous insulin in clinical
practice