Uncontrolled Type 1 Diabetic Patients Clinical Trial
| NCT number | NCT01592279 |
| Other study ID # | 597-11 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | Phase 4 |
| First received | April 30, 2012 |
| Last updated | May 3, 2012 |
| Start date | June 2012 |
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.
| Status | Not yet recruiting |
| Enrollment | 124 |
| Est. completion date | |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | No | |
| Secondary | Endogenous insulin secretion and residual ß-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 | No |