Since the main purpose of clinical phase I trials is to detect the toxic and side effects of drugs, a small number of healthy subjects are selected.
These people are carefully selected to ensure that they do not have any medical conditions or are taking other medications.
The insulin molecules used are third-generation insulin analogs that have passed the patent protection period, namely insulin aspart and insulin glargine.
The former is an ultra-short-acting insulin used during meals, and the latter is a long-acting insulin. The combination of the two has been tested by patients for a long time. It is not only safe, but also has the best effect. It can jointly control basal blood sugar and post-meal blood sugar. .
The ingredients of nanoparticles and absorption enhancers are also safe and harmless, so it passed the first phase of clinical trials in just one month.
When Weikang got the Phase I clinical trial report, he was very satisfied.
Although there are only about twenty cases, it is enough to prove the initial success of oral insulin.
"Yes, oral insulin does not have any toxic side effects in healthy people."
"The trial subjects took it before meals, and the spike in blood sugar was effectively controlled and remained stable within 24 hours, and there was no hypoglycemia at night."
“Once the most important safety data is obtained, we can expand the number of people to conduct phase II trials.”
"The next step is to recruit patients and conduct a random double-blind controlled trial."
Phase II clinical trials are mainly to verify the therapeutic effect and safety of the drug.
First, the effectiveness of the drug must be determined, compared with a placebo, and the patient's tolerance must be evaluated to determine the minimum dose.
Only when the efficacy of oral insulin has been verified in hundreds of patients and it is confirmed that there are no serious adverse reactions can large-scale phase III clinical trials be carried out in multiple hospitals.
At that time, it will be compared with similar drugs that are already on the market. It is necessary to prove that the efficacy of oral insulin is no worse than injected insulin before applying for a new drug marketing authorization.
Of course, with the breakthrough oral delivery method, as long as average treatment data can be obtained, even if the effect is worse than insulin injection, there is no doubt that it will obtain marketing approval.
The usual process is like this, but in order to obtain the most eye-catching data and pass the review as soon as possible, pharmaceutical companies will always carefully select patients for trial drugs to achieve the maximum therapeutic effect.
Sanqing is naturally no exception.
To highlight the huge gap between oral and injectable delivery, the biggest advantages of oral insulin are highlighted.
Wei Kang has set its sights on the group of diabetic patients with the worst compliance and the greatest benefit.
****
Kunming City, First People's Hospital.
Cao Fang hurried to the outpatient hall with her daughter in her arms. When she saw the registration and triage tables, there were already several long queues, and she suddenly became extremely anxious.
She looked at her daughter in her arms. The one-year-old child, with a thin face and a pointed face, was struggling to open her eyes, showing an innocent and lovely smile.
Cao Fang was heartbroken and blamed herself deeply. She wished she could slap herself hard and bear the blame for her daughter.
My daughter has just turned one year old and has been experiencing polydipsia and polyuria a few days ago. She drinks three times as much water as usual and the frequency of urination has also increased significantly.
It lasted for several days, but she didn't pay attention to it, and then she lost weight day by day. She thought it was because the diet was not nutritious, so she searched for formulas on the Internet to strengthen her daughter's nutrition, but there was no improvement.
Until yesterday, my daughter stopped breastfeeding, vomited frequently, and her mental state became very bad. She fell asleep at every turn and could not wake up when she screamed.
She was immediately frightened and took her daughter to a nearby hospital for pediatric treatment.
Unexpectedly, when I checked my blood sugar, it was as high as 32.5, 5 times higher than the normal range.
The doctor was shocked when he saw it and immediately asked them to come to the First People's Hospital for hospitalization, otherwise the child would fall into a coma at any time and his life would be at risk.
Cao Fang and his wife panicked for a moment and rushed to the hospital immediately.
But looking at the long queue, she was so anxious that she couldn't wait any longer.
She held her daughter in one hand and the test sheet in the other, begging one by one: "Hello, my child is about to fall into a coma. Can you let me register first?"
People near the window may have felt sympathy when they saw her holding her child and agreed to let her jump in line.
She explained the situation to the registration staff and then got the emergency number.
At this time, my daughter's face became even worse.
After waiting for about another minute, the child finally lay on the bed in the emergency room.
When the doctor saw the test report, he was immediately surprised: "Why is the blood sugar so high? I need to draw blood for retest quickly."
Then he started infusing the child with saline and observing the blood pressure and heartbeat.
At this time, the child's face was pale, lying quietly, and his breathing could be heard clearly.
Cao Fang looked at the beating numbers on the instrument and knew clearly that her daughter was still alive, and her anxious heart was finally relieved.
Half an hour later, the doctor frowned when he saw the re-examination results: "The blood sugar is too high. The child should be suffering from ketoacidosis and needs to be hospitalized immediately."
"The initial diagnosis is type I diabetes. Please be mentally prepared. This disease mainly causes the destruction of pancreatic beta cells, resulting in an absolute lack of insulin. The child will need insulin injections for the rest of his life, and he will not be able to recover."
"Now we can only use insulin to lower the blood sugar. We need to keep injecting to maintain the delivery of insulin, and we also need to supplement with normal saline. We can't give the child anything until the blood sugar drops."
"Tonight is especially critical. We must pay attention to the child's blood pressure, heartbeat, etc. If there is any discomfort, rescue must be carried out."
When Cao Fang heard the three words "diabetes", her mind suddenly buzzed. She could not understand what the doctor said after that, and only captured a few keywords.
"Lifelong", "Injection", "No recovery".
As she listened, her tears kept flowing down, and she was on the verge of collapse.
She could never imagine why her daughter would get diabetes when she was only one year old.
Isn’t diabetes exclusive to middle-aged and elderly people?
Why do such young children get sick?
Is it genetic? But no one in my family has ever had diabetes.
She followed the nurse in a daze as she moved the child to the ward, unable to think clearly.
Looking at the child's sleeping face, she took out her phone with trembling hands and began to search for relevant knowledge.
Three more and one less symptoms, ketoacidosis, type 1 diabetes, onset, causes, early manifestations, complications, treatment methods, etc. A huge amount of information poured in instantly.
Cao Fang's heart grew colder as she watched, but she kept searching for information. At this moment, she was like a drowning person, waving her hands frantically, trying to find the life-saving straw.
"Yes, there will definitely be miracles. We have been kind in our lives, have never done bad things, and have never hurt anyone. This kind of thing cannot happen to us. There must be miracles!"
"The doctor said that there is a 90% chance of it being type I, and there is still a 10% chance. Maybe we are the 10%."
"Maybe after the injection and the blood sugar level drops, I can happily take my daughter out of the hospital and never come to this place again."
"There are still variables in everything, don't worry, just calm down first."
She kept comforting herself. After a while, the tears in her eyes seemed to run away, and only her heart kept bleeding.
During the long night, the nurse worked in shifts and would come over every hour to prick his finger with a needle and measure his blood sugar. At the end of the night, small holes could be seen on the child's hands, and there were still blood stains on them that had not been wiped dry.
The needle stuck into the child, but it hurt Cao Fang's heart.
Her heart was sour and tortured, and she didn't close her eyes all night.
When it got daylight, I started to feel lucky that nothing scary happened, and the child's blood sugar slowly dropped.
During the ward rounds in the morning, I met the attending doctor.
"We are still correcting ketosis. The blood sugar has dropped and we can feed the child something to eat, but all food must be weighed."
The attending doctor said kindly: "Now you parents should start learning about diabetes, how to test blood sugar, how to calculate food, how to give injections, how to match insulin, how to deal with high blood sugar, the symptoms of hypoglycemia and how to deal with emergencies. etc."
"While hospitalized, parents must learn relevant knowledge well and know how to apply it before they can be discharged from the hospital."
"We need to check the status of ketosis again in the next few days. We need to monitor blood sugar at 8 points every day and blood ketone status at 3 points before meals."
From this moment on, Cao Fang began to officially enter the state of study and preparation. All situations were recorded in a notebook and summarized and corrected every day.
She seemed to have returned to her school days, with only one thought in her mind: she must let her daughter survive and be her strongest supporter. Even if she was sad, she had to secretly deal with her emotions.
The most difficult night has passed. As long as you live well, there will be unlimited opportunities and possibilities.
When her daughter woke up, she had wiped away her tears, put away her anxiety, and became the sunny mother with a smile on her face again.
Therefore, getting up on time, eating at regular intervals, taking injections, and measuring blood sugar became essential things for her every day.
In the evening, summarize the details of the day, count the specific consumption of breakfast, lunch, and dinner, convert the carbohydrates of the food, record the order of eating, and the blood sugar level for reference the next day.
He had to give 4 injections and measure blood sugar 4 times every day. After a few days, the child's fingers were pricked like a hornet's nest.
Moreover, when she tried to give her daughter injections, she was often frightened. Sometimes she would accidentally inject capillary bleeding, and it was difficult for beginners to find the adjustment rules to perfectly control blood sugar.
If you inject too little, your blood sugar will not be well controlled; if you inject too much, you will suffer from hypoglycemia.
This made her very anxious, constantly blaming herself, and even doubting herself, why she couldn't choose a better place to play, why she was so stupid, and couldn't do better or learn faster.
Fortunately, she also met other family members in the hospital, and everyone cheered each other up and learned how to better control her blood sugar.
Slowly, I gained some confidence and was no longer as scared as I was at the beginning.
A week passed quickly. After checking the room, the attending doctor looked at the child's scarred fingers and couldn't help but sigh.
He did not leave as usual, but hesitated for a long time before uttering a word.
"Cao Fang, your child's condition may require insulin treatment throughout his life."
"Type I diabetes is very troublesome. Currently there is no good treatment. The only way is to control blood sugar at a relatively stable level by injecting insulin. This process requires great patience and tenacity. Long-term subcutaneous injection may cause local hard lumps or lumps to appear on the skin. Shrink.”
"She is too small, and her skin and blood vessels are very fragile. If she keeps injecting like this, it will be a huge burden on the child."
"That's right, Sanqing has a clinical trial of oral insulin. Are you interested in participating in the trial? It may improve the situation."
Cao Fang raised her head suddenly, and a light flashed in her eyes: "Oral insulin? Do you mean to take the insulin like a pill? No more injections?"
The attending doctor nodded: "Yes, it's just like taking cold medicine, but you still need to control your diet and measure your blood sugar."
Cao Fang was ecstatic and said: "That's great, I'll sign up the child. You see, my child's body is covered with needle holes. His arms were pierced after his stomach was pierced, and his buttocks were pierced after his arms were pierced. It's so painful. If you can use oral medicine instead, I really want it.”
The doctor kindly reminded: "This drug has just been released and is undergoing Phase II clinical trials. It has not yet undergone large-scale clinical safety verification, and it is likely to have some adverse reactions."
Cao Fang said indifferently: "You already said that the medicine is from Sanqing Group. Their medicine is known for its safety. I feel reassured. Besides, if there are any adverse reactions, it is not too late to stop and continue injecting insulin."
"Okay, then you sign this agreement."
After signing, the doctor quickly brought over a plastic cup with a quarter of a pill in it.
"The medicine is here. Considering that the patient is only 1 year old, which is too young, I will give her the minimum dose."
"I'll ask the nurse to send it over on time, and you can just take it as you normally would for an injection."
Cao Fang carefully brought it to her daughter's mouth and poured it down with warm water. The tension in her heart dissipated a little.
"It should work." She encouraged herself secretly.
On the following day, she paid more attention to her daughter's condition than usual, fearing that she would suffer from coma, vomiting, etc.
Fortunately, after taking oral insulin, my daughter did not have any abnormal reactions and remained the same as before.
After a few days, it was just like injecting insulin. Blood sugar and blood pressure were very stable, with no abnormalities at all.
This made her marvel, and at the same time she was moved to tears.
Finally, I don’t have to stick needles into my daughter’s body every day. A one-year-old child is already small, and the places where she can get injections are limited.
My daughter's belly, butt, and little arms and legs are being tortured every day.
Moreover, it was fine when children were young, and parents could force their children to take injections. But when they get older, they will start to resist.
Some children may even develop a rebellious mentality and are unwilling to take insulin.
Parents can't keep an eye on them every day. Over time, it's easy for something to happen again.
If oral insulin can be used instead of injections, children will definitely be less resistant and can better control blood sugar and avoid health problems.
She has even thought about buying a painless blood glucose tester when oral insulin becomes available in the future.
My daughter will be able to completely get rid of the daily need for acupuncture and return to a normal life.
(End of chapter)
