GLP-1 Analogue Treatment in Uncontrolled Type 1 Diabetic Patients

NCT01592279 | Unknown Phase 4

• 1 other identifier: 597-11
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

liraglutide

EXPERIMENTAL

Drug: liraglutide

Insulin injections

ACTIVE COMPARATOR

Drug: Insulin injections

Interventions

liraglutide DRUG

liraglutide

Insulin injections DRUG

Insulin injections

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HbA1C ≥ 8 at screening and at qualification
• Not treated with GLP-1 analogue

You may not qualify if:

• Moderate and sever hypoglycemia
• Creatinin \> 2
• amylase or lipase \> 3xULN
• Calcitonin \> 10 pg/ml or Stimulated Calcitonin \> 50 pg/ml in women or 80 pg/ml in men
• ALT or AST \> 3X ULN

Sponsors & Collaborators

• Hadassah Medical Organization: lead

MeSH Terms

Interventions

Liraglutide

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 7, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Last Updated: May 7, 2012

Record last verified: 2012-04