GLP-1 Analogue Treatment in Uncontrolled Type 1 Diabetic Patients

Conditions

• Uncontrolled Type 1 Diabetic Patients

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• liraglutide — DRUG
• Insulin injections — DRUG

Study Details

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.

Key Dates

Start date

Jun 30, 2012

Status verified

Apr 2012

Primary completion

Jun 30, 2014

Study Design

Enrollment

124 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: liraglutide
• Active Comparator: Insulin injections

Primary Outcome Measure

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. [ Time Frame: the change in HbA1C relative to baseline after 3 months treatment with liraglutide in uncontrolled type 1 diabetic patients. ]