GLP-1 Analogue Treatment in Uncontrolled Type 1 Diabetic Patients

Phase 4

• Conditions: Uncontrolled Type 1 Diabetic Patients
• Interventions: Drug: Insulin injections; Drug: liraglutide

• Registration Number: NCT01592279
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-04
• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-05-03
• Last Update Submitted: 2012-05-03
• Study First Posted: 2012-05-07
• Last Update Posted: 2012-05-07
• Study Start: 2012-06
• Primary Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin injections	Insulin injections	-
liraglutide	liraglutide	-

Primary Outcome Measures

Name	Time	Method
The primary end point is the change in HbA1C relative to baseline after 3 months treatment with liraglutide in uncontrolled type 1 diabetic patients. The expected change is 1% reduction from baseline.	the change in HbA1C relative to baseline after 3 months treatment with liraglutide in uncontrolled type 1 diabetic patients.

Secondary Outcome Measures

Name	Time	Method
Endogenous insulin secretion and residual β-cell function estimated by the value of C-peptide	the change in C-peptide relative to baseline after 3 months treatment with liraglutide in uncontrolled type 1 diabetic patients