Type 1 Diabetes Clinical Trial
Official title:
The Effect of Saxagliptin on Glucose Fluctuation and Immune Regulation in Patients With Type 1 Diabetes
To investigate whether saxagliptin could reduce the fluctuation of glycemia and improve the glycemic control in those type 1 diabetes through mechanisms of suppressing glucagon secretion, improving beta cell function, and re-regulating of the T cell immune system.
Type 1 diabetes mellitus (T1DM) is characterized by immune mediated beta-cell destruction.
Due to the imbalance between glucagon and insulin, long-term T1DM patients experience
frequent hypoglycaemia and high glucose variability despite of multiple daily injections of
insulin.
Dipeptidyl peptidase 4 (DPP-4) inhibitors are a new class of anti-diabetic agents and are
widely used in clinical practice to improve glycemic control and protect β-cell function in
patients with type 2 diabetes mellitus(T2DM). Saxagliptin, a DPP-4 inhibitor, improves
glycemic control in patients with T2DM by increasing endogenous active, intact glucagon-like
peptide 1 and glucose-dependent insulinotropic polypeptide in response to food, which
augments insulin secretion and decreases glucagon release. This mechanism can lead to the
reduction of glucose variation. In some pilot studies, incretin-based therapy in patients
with T1DM can improve glucose control and reduce hypoglycemia, the mechanism probably is
that it regulates glucagon level. In type 1 diabetic mouse models, DPP-4 inhibitors
preserves beta-cell mass and stimulating beta-cell replication.
Interestingly, DPP-4 is also known as cluster of differentiation antigen 26(CD26).It is
expressed on the membrane of many types of lymphocyte, e.g. T, B and natural
killer(NK)cells, and is involved in their cellular functions. CD26 plays a key role in many
aspects in lymphocyte function beyond its DPP-4 enzymatic activity.These observations make
it a promising therapeutic target.
Recently, the attention of saxagliptin has been mainly focused on type 2 diabetes, data in
type 1 diabetes is rare. We are going to carry out this phase 4 study to testify our
hypothesis that saxagliptin could reduce the fluctuation of glycemia and improve the
glycemic control in those type 1 diabetes through mechanisms of suppressing glucagon
secretion, improving beta cell function, and re-regulating of the T cell immune system.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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