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

Conditions

• Maturity-onset Diabetes of the Young

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• liraglutide — DRUG
  The initial daily dose will be 0.6 mg for one week, 1.2 mg the following week and then 1.8 mg for the remaining treatment period. Patients who, due to adverse events, do not tolerate up-titration to 1.8 mg liraglutide will remain on 1.2 mg of liraglutide. The injection is administered once daily in the morning.
• Glimepiride — DRUG
  At randomisation patients will be initiated on their pre-study daily dose of glimepiride minus 0.5 mg. After one week the dose will be titrated (see below). Drug naïve patients will be initiated on an initial dosage of glimepiride of 0.5 mg for one week. Thereafter, glimepiride is increased to 1.0 mg and after another one week to 1.5 mg, and there after further up to 3 mg (if the average FPG during one week is above 6 mM). The dose of glimepiride can be increased up to 4 mg if average FPG is above 6 mM and no symptoms of hypoglycaemia are observed.

Study Details

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.

Key Dates

Start date

Aug 31, 2012

Status verified

Sep 2013

Primary completion

Aug 31, 2013

Completion

Aug 31, 2013

Study Design

Enrollment

15 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: liraglutide
• Active Comparator: glimepiride

Primary Outcome Measure

Fasting Plasma Glucose [ Time Frame: 14 weeks ]