Overview

GLP-1 Analogue Treatment in Uncontrolled Type 1 Diabetic Patients

Status:
Unknown status

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

Summary

The new incretin-based therapies offer appealing advantages over existing drugs. Aside from glucose dependent insulin secretion and a proven glucose lowering efficacy, they have other concomitant beneficial effects, such as low risk of hypoglycemia, inhibition of the glucagon secretion with maintenance of counter-regulatory mechanism, promotion of weight loss, and possible cardiovascular benefits (improvement of lipid profile, blood pressure, endothelial and myocardial function). The glucose lowering effects resulting from the inhibition of glucagon secretion and the gastric emptying rate could be of clinical importance in type 1 diabetes. The rationale behind the use of GLP-1 analogues in the treatment of type 1 diabetes relies on the assumption that these drugs, in addition to their action on insulin secretion and glucose regulation, may be effective in preserving and even expanding the β-cell mass. This class of drugs may represent an entirely new approach to the treatment of type 1 diabetes, focused on protection and preservation of β-cells. These therapies have the opportunity to interfere with the disease progression if used as an early intervention, when enough β-cell mass/ function can still be preserved or restored. Hypothesis: GLP-1 analogue (liraglutide) will improve glycemic control as measured by HbA1c in uncontrolled type 1 diabetic patients. The investigators expect a reduction of 1% in HbA1C from baseline.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hadassah Medical Organization

Treatments:

Insulin
Liraglutide

Criteria

Inclusion Criteria:

1. HbA1C ≥ 8 at screening and at qualification

2. Not treated with GLP-1 analogue

Exclusion Criteria:

1. Moderate and sever hypoglycemia

2. Creatinin > 2

3. amylase or lipase > 3xULN

4. Calcitonin > 10 pg/ml or Stimulated Calcitonin > 50 pg/ml in women or 80 pg/ml in men

5. ALT or AST > 3X ULN