The Effects of GLP-1 in Maturity-Onset Diabetes of The Young (MODY)

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the treatment potential of GLP-1-analogues in patients with Maturity Onset Diabetes of the Young (MODY) compared to common treatment.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Gentofte, Copenhagen
• Collaborators: Novo Nordisk A/S; University of Copenhagen
• Treatments: Glimepiride; Liraglutide

Criteria

Inclusion Criteria:

• Caucasian above 18 years of age

• Well characterised MODY3

• Body mass index (BMI) > 19 kg/m2

• Normal haemoglobin (males > 8.2 mM, females > 7.2 mM)

• Normal blood pressure (< 160/100 mmHg)

• Informed consent

• Capability to perform a light cycling test (heart rate 100-120 beats per minute during 30 minutes)

• Females: use of anticonception (IUC or hormonal)

Exclusion Criteria:

• Heart failure: New York Heart Association class III-IV

• Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine > 130 µM and/or albuminuria

• Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) > 2 × upper normal serum levels)

• Anaemia

• Acute or chronic pancreatitis

• Stroma or thyroid cancer

• Pregnancy or breast feeding

• Inability to complete the study

• Treatment naïve patients with HbA1c < 7.0 %

• Treatment with medicine that can not be paused for 12 hours

• Known allergic reaction to study medication

• Intention to become pregnant

• Unwillingness to complete the protocol