Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients

NCT01687582 | Completed

• 1 other identifier: UCL-DIAB-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate after 4 to 6 months the effects of a GLP-1 analog treatment on psoriatic skin lesions in patients with type 2 diabetes.

Conditions

Type 2 Diabetes; Psoriasis

Keywords

type 2 diabetes; psoriasis; exenatide; liraglutide

Outcome Measures

Primary Outcomes (1)

• Improvement of PASI score

  4 to 6 months

Secondary Outcomes (6)

• Evolution of BMI (body mass index)

  4 to 6 months

• Evolution of immunological data

  4 to 6 months

• Evolution of histopathological data

  4 to 6 months

• Evolution of glycaemic control

  4 to 6 months

• Evolution of routine laboratory measures

  4 to 6 months

Study Arms (1)

GLP-1 analog

EXPERIMENTAL

Liraglutide, 0.6 to 1.8 mg per day or Exenatide, 5 to 10 µg twice a day.

Drug: GLP-1 analog

Interventions

GLP-1 analog DRUG

GLP-1 analog treatment

Also known as: Liraglutide, Victoza or Exenatide, Byetta.

GLP-1 analog

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetic patients treated with oral anti-hyperglycaemic agents and/or insulin and presenting stable psoriasis plaques for at least one year, which failed to respond to previous systemic and/or topical treatments.

You may not qualify if:

• Type 1 diabetes
• Secondary diabetes
• Liver, renal or pancreatic disease
• Previous treatment with GLP-1 agonist or DPP-4 inhibitors agents

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (2)

• Buysschaert M, Tennstedt D, Preumont V. Improvement of psoriasis during exenatide treatment in a patient with diabetes. Diabetes Metab. 2012 Feb;38(1):86-8. doi: 10.1016/j.diabet.2011.11.004. Epub 2012 Jan 9.

  PMID: 22227407 BACKGROUND

• Hogan AE, Tobin AM, Ahern T, Corrigan MA, Gaoatswe G, Jackson R, O'Reilly V, Lynch L, Doherty DG, Moynagh PN, Kirby B, O'Connell J, O'Shea D. Glucagon-like peptide-1 (GLP-1) and the regulation of human invariant natural killer T cells: lessons from obesity, diabetes and psoriasis. Diabetologia. 2011 Nov;54(11):2745-54. doi: 10.1007/s00125-011-2232-3. Epub 2011 Jul 9.

  PMID: 21744074 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Psoriasis

Interventions

Liraglutide; Exenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Martin Buysschaert, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 19, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: March 12, 2019

Record last verified: 2019-03

Locations

BE (1)