GLP-1 Analogue Treatment in Uncontrolled Type 1 Diabetic Patients

NCT ID: NCT01592279

Last Updated: 2012-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30

Brief 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.

Conditions

Uncontrolled Type 1 Diabetic Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

liraglutide

Group Type: EXPERIMENTAL

liraglutide

Intervention Type: DRUG

Insulin injections

Group Type: ACTIVE_COMPARATOR

Insulin injections

Intervention Type: DRUG

Interventions

liraglutide

Intervention Type: DRUG

Insulin injections

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

597-11

Identifier Type: -

Identifier Source: org_study_id