In a nutshell
This phase 1 and 2 clinical trial is investigating the impact of using stem cells and drugs that suppress the immune system in type 1 diabetes (T1D). The main outcomes to be measured will be the change in production of insulin by the pancreas, and any serious side effects of treatment. This study is being conducted in Canada.
The details
T1D is an autoimmune disease, where the body’s immune system attacks the insulin-producing cells in the pancreas. This results in low levels of insulin, the hormone that lowers blood glucose. Plerixafor (Mozobil) is a drug that allows a person’s own stem cells to be removed from the blood, stored, and then returned to them. Drugs like alemtuzumab (MabCampath), anakinra (Kineret), and etanercept (Enbrel) can supress the immune system, and may stop the destruction of the pancreas. Returning the patient’s stem cells after using these drugs may allow new immune cells, that will not destroy the pancreas, to be made. Liraglutide (Victoza) is a drug that treats diabetes, and may help repair the insulin-producing cells in the pancreas.
The main outcomes will be measured as the change in production of insulin by the pancreas, and any serious side effects of treatment.
Who are they looking for?
This trial is looking for 60 adults who have had T1D for less than 6 months. Their pancreas must still be producing some insulin. Their HbA1c level (measures average blood glucose over the last 3 months) should be less than 12%.
Participants may not have significant complications of diabetes, severe heart disease, kidney disease, liver disease, psychiatric disease, anemia, a history of cancer or serious infection (including hepatitis, HIV, TB, and syphilis). They may not have a history of drug addiction. They may not be receiving drugs to treat blood clotting (except aspirin). They may not have participated in a clinical trial of a drug in the last 3 months. In the last month they may not have used a drug to suppress the immune system, received a vaccine, or had surgery. Participants (male and female) must not be planning to have children, and female participants may not breast-feed.
How will it work
The participants will be divided, randomly, into two groups. The first group will receive injections of alemtuzumab, anakinra, etanercept, and liraglutide on the first day. They will receive an injection of plerixafor the next day. They will continue with injections of anakinra daily for 1 year, of liraglutide daily for 2 years, and of etanercept twice weekly for 3 months and then weekly for another 9 months. The second group will be monitored for 1 year, without receiving treatment. They will then be treated in the same way as the first group for 1 year.
Insulin production by the pancreas, HbA1c, and the dose of any insulin injections used will be assessed at the start and after 3, 6, 9, 12, 18, and 24 months. T-cells, found in the blood (part of the immune system) will also be examined at this time. Antibodies (another part of the immune system) will be examined at the start and end of the study. Any side effects that occur, including hypoglycemia (dangerously low blood glucose), will be noted.
Clinical trial locations
Type: | Interventional |
Participants: | 60 |
Study ID: | NCT03182426 |