GLP-1 Analogue Treatment in Uncontrolled Type 1 Diabetic Patients

Hadassah Medical Center

Status and phase: Unknown; Phase 4

Conditions: Uncontrolled Type 1 Diabetic Patients

Treatments: Drug: Insulin injections; Drug: liraglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT01592279

597-11

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups

liraglutide

Experimental group

Treatment:

Drug: liraglutide

Insulin injections

Active Comparator group

Treatment:

Drug: Insulin injections