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GLP-1 Analogue Treatment in Uncontrolled Type 1 Diabetic Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Hadassah Medical Organization Identifier:
First received: April 30, 2012
Last updated: May 3, 2012
Last verified: April 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.


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 Intervention Phase
Uncontrolled Type 1 Diabetic Patients
Drug: liraglutide
Drug: Insulin injections
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 124
Study Start Date: June 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: liraglutide Drug: liraglutide
Active Comparator: Insulin injections Drug: Insulin injections


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
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  More Information

Responsible Party: Hadassah Medical Organization Identifier: NCT01592279     History of Changes
Other Study ID Numbers: 597-11
Study First Received: April 30, 2012
Last Updated: May 3, 2012

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 25, 2017