Incretin Effect on the Immunological Phenotype

Medical University of Graz

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes

Treatments: Drug: Saxagliptin; Drug: Liraglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT01782261

ADPP004

2011-006300-12 (EudraCT Number)

Details and patient eligibility

About

Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune cells in healthy subjects and patients with type 1 diabetes

Full description

Assessment of immunological effects of Saxagliptin and Liraglutide on immune cells of the peripheral blood.

Enrollment: 15 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

-healthy subjects or patients with type 1 diabetes

Exclusion criteria

• pregnancy
• treatment with GLP-1-Analoga (Liraglutide, Exenatide)
• treatment with DPP4-inhibitor (Sitagliptin, Vildagliptin, Saxagliptin)
• chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Liraglutide

Experimental group

Description:

Liraglutide subcutaneous injection every day. first week 0.6mg, week 2-4 1.2mg.

Treatment:

Drug: Liraglutide

Saxagliptin

Active Comparator group

Description:

Saxagliptin 5mg tablet by mouth every day for 4 weeks

Treatment:

Drug: Saxagliptin