Diabetes is a disease in which the blood glucose level is abnormally increased.
As the blood sugar increases, the following symptoms occur:
The symptoms are present in both type 1 and type 2 diabetes but the symptoms of type 1 diabetes develop rapidly, within a few days to weeks, while the development of type 2 diabetes is usually gradual (up to 10 years). During this period, the person can be free om symptoms.
1921: Canadian doctor Frederick Banting and his 21-year-old medical student, Charles Best, were the first to extract insulin-from a dog. In 1923, they were both honoured with the Nobel Prize.
1923: Nordic Insulin Laboratory (later Novo Nordisk) releases its first insulin preparation on the market.
1936: A new long acting ZPI insulin is introduced. Diabetics could now be satisfied with fewer daily injections.
1959: The researchers define two types of diabetes. Type 1 diabetics who cannot produce insulin themselves and are therefore insulin dependent and type 2 diabetics who are able to produce insulin.
1974: New types of extremely pure pig-based insulin come on the market.
1986: Human insulin based on genetic engineering is introduced.
1995: Metformin tablets are offered for the first time to type 2 diabetics.
2005: A whole new category of medicine, GLP-1, is introduced to the market for treatment of type 2 diabetics as an alternative to or postponement of insulin treatment. The medicine is sold under names like Victoza, Byetta and Lyxumia.
2006: A new diabetes medication is introduced, called DPP-4 (Januvia, Galvus, Tradjenta).
2013: SGLT-2 inhibitor medicine is offered for the first time to type 2 diabetics with high blood sugar levels.
It starts with the actual researchers, who can be doctors, pharmacists or biochemists. They can be employed either in the pharmaceutical industry or in independent research institutes. The researchers experiment with gene therapy, new active substances and new technology. Once a new drug has been developed in the laboratory, tests on mice or rats begin to test the drug’s effect.
If the results of the animal testing prove successful, the next step is testing the drug on human subjects in clinical trials, which always take place in the hospitals and clinics where the patients are. It is here, in the hospitals and clinics, that responsibility for the next step of research is granted to the study nurses and doctors. These roles are defined as an investigator. The initial researchers are not allowed to be involved with the clinical trials to ensure they cannot affect the outcome of the clinical trials.
Before a clinical trial can start, it must be approved by the health authorities in every country, where the trial takes place. The medical trial, in the form of a protocol, describes in detail the purpose of the study as well as how it is to be conducted. In addition, the Ethics Committee in all participating countries must approve the trial after carefully considering the ethical protection of the participants.
The clinical trials are conducted in four phases – read more here. It starts with phase 1, with a small number of participants and proceeds to phase 4, with several thousand participants.
It typically takes 3-4 years, from the start of the clinical trial, until the new medicine is ready to be released on to the market. Not every clinical trial has the positive outcome of new medication development.