GLP-1 Analogue Treatment in Uncontrolled Type 1 Diabetic Patients

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.

Study Overview

• Status: Unknown
• Conditions: Uncontrolled Type 1 Diabetic Patients
• Intervention / Treatment: Drug: liraglutide; Drug: Insulin injections

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: liraglutide	Drug: liraglutide
Active Comparator: Insulin injections	Drug: Insulin injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): June 1, 2014
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: April 30, 2012
• First Submitted That Met QC Criteria: May 3, 2012
• First Posted (Estimate): May 7, 2012

Study Record Updates

• Last Update Posted (Estimate): May 7, 2012
• Last Update Submitted That Met QC Criteria: May 3, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: 597-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No