Clinical Studies
Case Study

The following case study was carried out with Ketoconazole since it was initiated before the development of CORT001.

63-year-old woman with heredity for diabetes type 2. She had been abdominally obese since 30 years of age. 1979 treated for cancer. Diabetes type 2 since 1980. The patient initially received treatment with oral agents without success and was therefore given treatment with short-acting insulin 20 U at meals and long-acting insulin 40 U at night. Despite this treatment the patients glucose levels were not well controlled with regulation of HbA1c, levels above 8. The patient was also found to have hypertension and elevated blood lipids with cholesterol levels in the order of 10-14 mmol/L, thus a full Metabolic Syndrome.

In 1996 a treatment with ketoconazole in the dose of 400 mg daily given at bedtime started. After a week the glucose levels started to decrease steadily, for the first time in 16 years. The following year the HbA1c levels were in the order of 6%. The elevated liver enzymes became normalized within a couple of weeks. Also blood pressures and serum cholesterol values were improved.

In September 1998 the patient were again diagnosed with cancer and she was treated with surgery, radiotherapy and cytostatic agents. In connection with this treatment the patient was asked to stop treatment with ketoconazole. The following months the HbA1c values increased steadily up to as much as 10,4%.

With this background the patient decided on her own initiative to re-initiate the treatment with ketoconazole. As a result of this, the blood glucose levels once again started to decrease. Since the patient monitored her own blood glucose she was also able to closely follow this development herself. The following year the HbA1c levels again decreased to levels in the order of 6%. Also serum cholesterol and blood pressures was improved in parallel. See diagram below for further details.

During the whole period the patient was also treated in parallel with complementary drugs due the hypertension and elevated blood lipids. She was treated with drugs such as Renitec, Lasix Retard and Pravachol. After the latest re-initiation of ketoconazole treatment the blood pressure values decreased to levels where the previous dose of Renitec could be reduced by 50%.

It is interesting to note that in association with ketoconazole treatment the decrease in HbA1c values is occurring slowly during a period of approx. 6 months until optimal effect is reached. It can also be reported that if the patient for some reason stops ketoconazole treatment for some few days, the blood glucose levels start to increase, as measured in daily samples, and the insulin doses need to be up regulated. During both periods of ketoconazole treatment the need for external insulin was reduced in the order of 30%.

During this treatment the patient has not had any clinical or laboratory sign of cortisol deficiency. No ketoconazole-associated side effects have been reported.
The patient has been monitored by Prof. Stefan Arver at the Karolinska Hospital in Stockholm.

Case study diagram