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

NCT01610934 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-09-05

No results posted yet for this study

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.

Conditions

  • Maturity-onset Diabetes of the Young

Interventions

DRUG

liraglutide

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.

DRUG

Glimepiride

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.

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • University of Copenhagen

    collaborator OTHER

  • University Hospital, Gentofte, Copenhagen

    lead OTHER

Principal Investigators

  • Signe H Østoft, MD · Diabetes Research Division, University Hospital Gentofte, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01610934 on ClinicalTrials.gov