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*Only for medical professionals to read and refer to once a day at any time injection, effectively control fasting and
blood sugar throughout the day, T2DM injection treatment can also be very simple
.
Innovation-driven combination, compound biologics combined with different peptide bioactive molecules have high
requirements for the stability of the formulation.
Based on fatty acid acylation technology and unique formulation and process innovation, the world's first basal insulin glucagon-like peptide-1 receptor agonist (GLP-1RA) injection, the Chinese launch of Degludec insulin liraglutide injection (IDegLira), brings the possibility
of innovative combination therapy.
The application of innovative drugs requires clinicians to constantly explore and summarize, before, IDegLira has accumulated rich and high-quality Chinese evidence-based medical evidence in the treatment of type 2 diabetes mellitus (T2DM), and we are also very honored to share IDegLira's clinical preliminary clinical cases and provide reference
in the clinical practice of the majority of endocrinologists in China.
Middle-aged women, 4 years of disease, glycated hemoglobin (HbA1c) after treatment with two oral hypoglycemic drugs (OAD).
8.
1%, accompanied by overweight and hyperlipidemia, metabolism-related steatohepatitis, white-collar elites, busy work, outpatient visits.
.
.
When a T2DM patient is labeled above, what can be done to improve metabolism while taking into account the efficacy and safety of hypoglycemia? What role did IDegLira play in the treatment process? What are the benefits for patients? Next, let's learn together in the case provided by Professor Zhang Lihui of the Second Hospital of Hebei Medical University.
The patient's female 40 years old complained: increased blood glucose for more than 4 years and poor blood glucose control for 3 months
.
▎ History of present illness
.
▎Family history: Father and brother suffer from diabetes
.
▎General temperature: 36.
3 °C, pulse 72 times/min, breathing 18 times/min, blood pressure 125/80mmHg
.
▎Physical examination
on the face.
Cervix: no abnormalities
.
Lymph nodes: unpalpated enlargement
.
Lungs: clear breath sounds in both lungs, no wet and dry rales
heard.
Heart: heart rate 72 beats per minute, regular rhythm
.
Abdomen: the abdomen is flat, the whole abdomen is not tender, and the liver and spleen are not palpated
under the ribs.
Extremities: no abnormalities
.
Specialist examination: dorsal bifoot pulsations may occur
.
▎Laboratory blood glucose: HbA1c8.
1%; FPG 11.
52mmol/L； PPG 13.
2mmol/L； Blood lipids: total cholesterol (TC) 5.
60mmol/L; Low-density lipoprotein cholesterol (LDL-c) 3.
55mmol/L; High-density lipoprotein cholesterol (HDL-c) 1.
07mmol/L; Triglycerides (TG) 1.
05mmol/L; Liver function: alanine aminotransferase (ALT) 47.
3U/L; Aspartate aminotransferase (AST) 31.
5 U/L
.
▎Other auxiliary examinations
Type 2 diabetes mellitus 2.
Hyperlipidemia3.
Metabolism-related steatohepatitis?
▎Treatment plan
Professor Zhang Lihui: First of all, this patient has a young onset, the course of the disease is 4 years, and the current combination of two OADs (metformin, acarbose) is used to treat poor blood sugar control, no diabetes-related complications, and a long life expectancy in the future.
According to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition) [1], for most non-pregnant adult T2DM patients, reasonable blood glucose control targets are FPG 4.
4~6.
0mmol/L and HbA1c <7%.
Based on the patient's situation, we set a blood glucose control target of FPG<6.
0mmol/L and HbA1cwithin 7%.
Patients currently have HbA1c8.
1%, FPG 11.
52mmol/L, PPG 13.
2mmol/L, mainly FPG elevation, FPG reduction as the primary goal, basal insulin
preferred.
At the same time, considering that the patient's BMI is 27.
8kg/m2, waist circumference is 87cm abdominal obesity, combined with metabolism-related steatohepatitis and hyperlipidemia, a series of metabolic disorders need to be comprehensively managed
.
This requires treatment to avoid the risk
of weight gain.
Therefore, the GLP-1RA is also the first option
to consider.
On the other hand, patients are usually busy with work, and the convenience and compliance of treatment plans also need to be considered
.
Professor Zhang Lihui: Our endocrinologists are no strangers to basal insulin and GLP-1RA alone and in combination, and we have summarized our own experience in clinical practice
.
IDegLira combines the two active ingredients into a formulation according to the ratio of 10U insulin degluglutide to 0.
36mg liraglutide, and the clinical use and dose adjustment method of this ratio needs to be explored and summarized by clinicians
.
For the starting dose, the two pairs of numbers we need to remember the most are 10U-0.
36mg and 16U-0.
6mg
.
For patients with unsatisfactory response to previous OAD treatment, the initial treatment is 10U-0.
36 mg; for patients who have previously been treated with injection, the initial treatment is 16U-0.
6 mg, because there is no need to worry about the initial gastrointestinal adverse effects
caused by GLP-1RA at this dose 。 Then according to the FPG level, adjust the dose every 3~4 days, the adjustment method is the same as the basal insulin adjustment method, it is precisely because of the role of the two components, we found that compared with basal insulin treatment alone, FPG control is better, dose saving, while the risk of hypoglycemia is lower, no weight gain, patients with large insulin doses in the past even lose weight after conversion
.
: Professor Zhang Lihui
Chinese Journal of Diabetes.
2021; 13:315‐409.
[2] American Diabetes Association Professional Practice Committee.
9.
Pharmacologic approaches to glycemic treatment:standards of medical care in diabetes-2022[J].
Diabetes Care,2022,45(Suppl 1):S125-S143.
[3] Rodbard H W, Bode B W, Harris S B, et al.
Safety and efficacy of insulin degludec/liraglutide (IDegLira) added to sulphonylurea alone or to sulphonylurea and metformin in insulin-naïve people with type 2 diabetes: the DUAL Ⅳ trial[J].
Diabet Med, 2017, 34(2): 189-196.
[4] Gough S C, Bode B, Woo V, et al.
Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes[J].
Lancet Diabetes Endocrinol,2014,2(11): 885-893.
[5]Linjawi S, et al.
Diabetes Ther.
2017; 8(1):101-114.
[6]Lingvay I, et al.
JAMA.
2016; 315(9):898-907.
[7] Mu Yiming, Hu Bei.
Journal of Clinical Pharmacotherapy.
2022; 20(06):16-20.
[8]Price H, et al.
Diabetes Obes Metab.
2018 Apr; 20(4):954-962.
Where to see more endocrinology clinical knowledge? Come to the "Doctor's Station" and take a look-End 👇
-
"This article is only for providing scientific information to medical and health professionals and does not represent the position of the platform"
blood sugar throughout the day, T2DM injection treatment can also be very simple
.
Innovation-driven combination, compound biologics combined with different peptide bioactive molecules have high
requirements for the stability of the formulation.
Based on fatty acid acylation technology and unique formulation and process innovation, the world's first basal insulin glucagon-like peptide-1 receptor agonist (GLP-1RA) injection, the Chinese launch of Degludec insulin liraglutide injection (IDegLira), brings the possibility
of innovative combination therapy.
The application of innovative drugs requires clinicians to constantly explore and summarize, before, IDegLira has accumulated rich and high-quality Chinese evidence-based medical evidence in the treatment of type 2 diabetes mellitus (T2DM), and we are also very honored to share IDegLira's clinical preliminary clinical cases and provide reference
in the clinical practice of the majority of endocrinologists in China.
Middle-aged women, 4 years of disease, glycated hemoglobin (HbA1c) after treatment with two oral hypoglycemic drugs (OAD).
8.
1%, accompanied by overweight and hyperlipidemia, metabolism-related steatohepatitis, white-collar elites, busy work, outpatient visits.
.
.
When a T2DM patient is labeled above, what can be done to improve metabolism while taking into account the efficacy and safety of hypoglycemia? What role did IDegLira play in the treatment process? What are the benefits for patients? Next, let's learn together in the case provided by Professor Zhang Lihui of the Second Hospital of Hebei Medical University.
Case data
The patient's female 40 years old complained: increased blood glucose for more than 4 years and poor blood glucose control for 3 months
.
▎ History of present illness
4 years ago, during the physical examination, it was found that the fasting blood glucose (FPG) was 8.
3mmol/L, there were no obvious symptoms of dry mouth, polyuria, polydipsia, and the postprandial blood glucose (2h-PPG) was 13.
2mmol/L within 2 hours, and oral metformin 1.
0g was started, twice daily (BID).
Post-test blood glucose control is better
.
1 year ago, 2h-PPG > 10mmol/L was measured multiple times, plus acarbose 50mg, three times a day (TID); In the past three months, blood glucose control is poor, especially FPG is high
.
.
▎Family history: Father and brother suffer from diabetes
.
▎General temperature: 36.
3 °C, pulse 72 times/min, breathing 18 times/min, blood pressure 125/80mmHg
.
▎Physical examination
Height: 166.
5cm, weight: 77kg, body mass index: 27.
8kg/m2, waist circumference: 87cm
.
on the face.
Cervix: no abnormalities
.
Lymph nodes: unpalpated enlargement
.
Lungs: clear breath sounds in both lungs, no wet and dry rales
heard.
Heart: heart rate 72 beats per minute, regular rhythm
.
Abdomen: the abdomen is flat, the whole abdomen is not tender, and the liver and spleen are not palpated
under the ribs.
Extremities: no abnormalities
.
Specialist examination: dorsal bifoot pulsations may occur
.
▎Laboratory blood glucose: HbA1c8.
1%; FPG 11.
52mmol/L； PPG 13.
2mmol/L； Blood lipids: total cholesterol (TC) 5.
60mmol/L; Low-density lipoprotein cholesterol (LDL-c) 3.
55mmol/L; High-density lipoprotein cholesterol (HDL-c) 1.
07mmol/L; Triglycerides (TG) 1.
05mmol/L; Liver function: alanine aminotransferase (ALT) 47.
3U/L; Aspartate aminotransferase (AST) 31.
5 U/L
.
▎Other auxiliary examinations
Ultrasound of the abdomen: fatty liver
▎Previous blood glucose monitoring and hypoglycemiaFPG about 9mmol/L; 2h-PPG about 13mmol/L; No hypoglycemia
has occurred.
Type 2 diabetes mellitus 2.
Hyperlipidemia3.
Metabolism-related steatohepatitis?
▎Treatment plan
Combine IDegLira 10 doses on the basis of the original regimen
Doctor shares
Medical community: What are the considerations for choosing the innovative drug IDegLira for this patient? What is your patient's feedback after switching protocols?
Professor Zhang Lihui: First of all, this patient has a young onset, the course of the disease is 4 years, and the current combination of two OADs (metformin, acarbose) is used to treat poor blood sugar control, no diabetes-related complications, and a long life expectancy in the future.
According to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition) [1], for most non-pregnant adult T2DM patients, reasonable blood glucose control targets are FPG 4.
4~6.
0mmol/L and HbA1c <7%.
Based on the patient's situation, we set a blood glucose control target of FPG<6.
0mmol/L and HbA1cwithin 7%.
Patients currently have HbA1c8.
1%, FPG 11.
52mmol/L, PPG 13.
2mmol/L, mainly FPG elevation, FPG reduction as the primary goal, basal insulin
preferred.
At the same time, considering that the patient's BMI is 27.
8kg/m2, waist circumference is 87cm abdominal obesity, combined with metabolism-related steatohepatitis and hyperlipidemia, a series of metabolic disorders need to be comprehensively managed
.
This requires treatment to avoid the risk
of weight gain.
Therefore, the GLP-1RA is also the first option
to consider.
On the other hand, patients are usually busy with work, and the convenience and compliance of treatment plans also need to be considered
.
Based on this, we finally chose the innovative drug of basal insulin GLP-1RA injection for patients, which can endogenously regulate exogenous supplementation of insulin, improve insulin resistance, retain and not increase hypoglycemia, and specifically regain benefits
.
Moreover, the advantages of this treatment plan have also been recognized by authoritative guidelines at home and abroad, and the "Diabetes Diagnosis and Treatment Standards" issued by the American Diabetes Association (ADA) in 2022 [2] It was noted that GLP-1RA was given priority to T2DM patients with poorly controlled OAD, and that treatment with primed basal insulin GLP-1RA injection had a stronger hypoglycemic effect and persistence
compared with starting basal insulin.
The Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition) [1] also mentioned that IDegLira has a better hypoglycemic effect than basal insulin when insulin doses are the same or lower, and can reduce the risk of hypoglycemia and avoid adverse reactions such as weight gain caused by insulin therapy
。
In evidence-based evidence, HbA 1c values decreased by up to 1.
5 percent from baseline to 6.
4 percent 26 weeks after initiating IDegLira treatment in patients with T2DM treated with sulfonylureas/metformin [3
].
。 In patients with poor glycemic control treated with metformin/pioglitazone, the hypoglycemic efficacy of OAD combined with IDegLira was better than that of OAD combined with insulin degludec and OAD combined with liraglutide (IDegLira, insulin degludec and liraglutide group, respectively, the HbA1c reduction was 1.
9% and 1.
4%, respectively and 1.
3%)[4].
In addition, IDegLira has been observed to significantly improve systolic blood pressure and blood lipid profile (total cholesterol, very low-density lipoprotein cholesterol, triglycerides, etc.
) in the DUAL series of studies [5-6].
At the same time, the once-daily injection regimen is also simpler
.
In the middle of the follow-up process, we saw that the patient's blood glucose was effectively controlled, and in the first week of medication, FPG decreased from 11.
52mmol/L to 6.
2mmol/L, PPG decreased from 13.
2mmol/L to 9.
2mmol/L, and in the second week, FPG was further reduced to 5.
6mmol/L and PPG was further reduced to 8.
5mmol/L, and no hypoglycemia occurred
.
This result is very satisfactory
for us and the patient.
The medical community: The initial stage of clinical use of innovative drugs especially needs to be explored and shared at the expert level, IDegLira has been on the market for nearly 8 months, please combine this case and your years of clinical experience, please share with us what characteristics of IDegLira are suitable for patients in the clinic?
Professor Zhang Lihui: Our endocrinologists are no strangers to basal insulin and GLP-1RA alone and in combination, and we have summarized our own experience in clinical practice
.
IDegLira combines the two active ingredients into a formulation according to the ratio of 10U insulin degluglutide to 0.
36mg liraglutide, and the clinical use and dose adjustment method of this ratio needs to be explored and summarized by clinicians
.
For the starting dose, the two pairs of numbers we need to remember the most are 10U-0.
36mg and 16U-0.
6mg
.
For patients with unsatisfactory response to previous OAD treatment, the initial treatment is 10U-0.
36 mg; for patients who have previously been treated with injection, the initial treatment is 16U-0.
6 mg, because there is no need to worry about the initial gastrointestinal adverse effects
caused by GLP-1RA at this dose 。 Then according to the FPG level, adjust the dose every 3~4 days, the adjustment method is the same as the basal insulin adjustment method, it is precisely because of the role of the two components, we found that compared with basal insulin treatment alone, FPG control is better, dose saving, while the risk of hypoglycemia is lower, no weight gain, patients with large insulin doses in the past even lose weight after conversion
.
The clinical treatment effect of synergy and vice reduction gives doctors and patients a strong confidence in high-quality blood glucose management, and traces the origin, thanks to its unique mechanism
of action.
That is, insulin degludec and liraglutide act simultaneously with insulin receptor and GLP-1 receptor, respectively, covering the multiple complex pathophysiological mechanisms of T2DM, and acting simultaneously in various target organs and tissues to achieve "synergistic complementarity and targeted regulation" [7].
Although clinical experience is still slowly accumulating, the benefits of patients in this case are only one of the microcosms
.
The people who are suitable for IDegLira have been accumulated and represented
in its real-world evidence.
In a multicenter, retrospective EXTRA study in Europe [8], 611 patients previously treated with different glucose-lowering regimens were treated with multiple daily insulin injections plus OAD, GLP-1RA plus OAD, insulin plus OAD, or GLP-1RA prior to switching to IDegLira
.
The results showed that after 6 months of switching to the IDegLira regimen, HbA1c levels decreased significantly (0.
9%, p<0.
0001), <b14>and the average body weight of patients decreased from baseline (P<0.
05).
</b15>
: Professor Zhang Lihui
- Director of Department of Endocrinology, Second Hospital of Hebei Medical University
- Chief physician, professor, doctoral supervisor
- Vice Chairman of the Diabetes Branch of the Chinese Gerontology and Geriatrics Association
- Member of the Standing Committee of the Endocrinology Professional Committee of the Chinese Medical Association
- Member of Diabetes and Microcirculation Branch of Chinese Microcirculation Society
- Chairman of the Diabetes Branch of Hebei Medical Association
- Chairman of the Diabetes Prevention and Treatment Professional Committee of Hebei Preventive Medicine Association
- Honorary Chairman of Endocrinology Branch of Hebei Emergency Medical Association
- Chairman of the Endocrine and Metabolic Drugs Branch of Hebei Pharmaceutical Association
- Editorial Board Member, Chinese Journal of Endocrinology and Metabolism
- Corresponding Editor of Chinese Journal of Diabetes
- Editorial Board Member of Journal of Hebei Medical University, etc
References:
[1] Diabetes Branch of Chinese Medical Association.Chinese Journal of Diabetes.
2021; 13:315‐409.
[2] American Diabetes Association Professional Practice Committee.
9.
Pharmacologic approaches to glycemic treatment:standards of medical care in diabetes-2022[J].
Diabetes Care,2022,45(Suppl 1):S125-S143.
[3] Rodbard H W, Bode B W, Harris S B, et al.
Safety and efficacy of insulin degludec/liraglutide (IDegLira) added to sulphonylurea alone or to sulphonylurea and metformin in insulin-naïve people with type 2 diabetes: the DUAL Ⅳ trial[J].
Diabet Med, 2017, 34(2): 189-196.
[4] Gough S C, Bode B, Woo V, et al.
Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes[J].
Lancet Diabetes Endocrinol,2014,2(11): 885-893.
[5]Linjawi S, et al.
Diabetes Ther.
2017; 8(1):101-114.
[6]Lingvay I, et al.
JAMA.
2016; 315(9):898-907.
[7] Mu Yiming, Hu Bei.
Journal of Clinical Pharmacotherapy.
2022; 20(06):16-20.
[8]Price H, et al.
Diabetes Obes Metab.
2018 Apr; 20(4):954-962.
Where to see more endocrinology clinical knowledge? Come to the "Doctor's Station" and take a look-End 👇
-
"This article is only for providing scientific information to medical and health professionals and does not represent the position of the platform"
