GLP-1 Analogue Treatment in Uncontrolled Type 1 Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01592279
Recruitment Status : Unknown
Verified April 2012 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : May 7, 2012
Last Update Posted : May 7, 2012
Information provided by (Responsible Party):
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.


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.

Condition or disease Intervention/treatment Phase
Uncontrolled Type 1 Diabetic Patients Drug: liraglutide Drug: Insulin injections Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2012
Estimated Primary Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: liraglutide Drug: liraglutide
Active Comparator: Insulin injections Drug: Insulin injections

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

Secondary Outcome Measures :
  1. Endogenous insulin secretion and residual β-cell function estimated by the value of C-peptide [ Time Frame: the change in C-peptide relative to baseline after 3 months treatment with liraglutide in uncontrolled type 1 diabetic patients ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Hadassah Medical Organization Identifier: NCT01592279     History of Changes
Other Study ID Numbers: 597-11
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists