Does a GLP-1 Receptor Agonist Change Glucose Tolerance in Antipsychotic-treated Patients?

Conditions

• Impaired Glucose Tolerance Associated With Drugs

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Liraglutide — DRUG
  Once a day 1,8 mg subcutaneous injection for 16 weeks
• Liraglutide Placebo — DRUG
  Once a day 1,8 mg subcutaneous injection for 16 weeks

Study Details

Metabolic disturbances, obesity and life-shortening cardiovascular morbidity are major clinical problems among antipsychotic-treated patients. Especially two of the most efficacious antipsychotics, clozapine and olanzapine, cause weight gain and metabolic disturbances and can rarely be replaced by other drugs due to the effectiveness of the compounds. Glucagon-like peptide 1 (GLP-1) has improved glycemic control among patients with type 2 diabetes. The study will investigate whether the beneficial effects of GLP-1 analogues on glycemic control in type 2 diabetic patients, can be extended to a population of non-diabetic, dysglycemic psychiatric patients, receiving antipsychotic medical treatment.

Key Dates

Start date

Apr 30, 2013

Status verified

May 2016

Primary completion

Mar 31, 2016

Completion

Mar 31, 2017

Study Design

Enrollment

103 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Liraglutide
  Once a day 1,8 mg subcutaneous injection for 16 weeks
• Placebo Comparator: Liraglutide placebo
  Once a day 1,8 mg subcutaneous injection for 16 weeks

Primary Outcome Measure

Glucose tolerance [ Time Frame: Baseline - 16 weeks ]