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Trial · Interventional

CompletedPhase 2/3Registry data

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

NCTNCT01610934 (opens ClinicalTrials.gov in a new tab)Other idMODY-TREATOther id2012-000592-17
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
15 participants (actual)
Sponsor
University Hospital, Gentofte, Copenhagen · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
Aug 2012
Primary completion
Aug 2013
Completion
Aug 2013
First posted
4 Jun 2012 (estimated)
Last update posted
5 Sept 2013 (estimated)
Conditions
Maturity-onset Diabetes of the Young

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 2/3

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

    NCT01610934

    Aug 2012 to Aug 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutideDrug
  • GlimepirideDrug

Arms2

  • Experimental

    liraglutide

  • Active comparator

    glimepiride

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Fasting Plasma Glucose

    Time frame · 14 weeks

    Registry description

    Glycaemic control will be evaluated by FPG monitored twice weekly, 7-point PG profiles every two weeks and 3 blinded 48-hour continuous PG profiles (before randomisation and at the end of both treatment periods). The patients who will be their own controls, will randomly be assigned (after one week washout of usual antidiabetic treatment) to receive either liraglutide or glimepiride for 6 weeks, and after another one-week washout period treated with the opposite treatment for 6 weeks.

Secondary outcomes(5)

  1. Serum Fructosamine

    Time frame · 14 weeks

    Registry description

    Fructosamine is a time-averaged indicator of PG levels. It reflects the total amount of glycated proteins such as glycohaemoglobin and glycoalbumin in a blood sample. The turnover of serum proteins (albumin has a half-life of 19 days) is less than that of haemoglobin, and therefore fructosamine determinations provide a means of monitoring patient blood glucose status over a shorter period (1-3 weeks) than glycohaemoglobin (6-8 weeks).

  2. Hypoglycemic events

    Time frame · 14 weeks

    Registry description

    Hypoglycaemic events will be reported by the patient in a diary. During cycling tests patients will be tested further according to hypoglycaemia. Mild hypoglycaemia is defined as episodes with symptoms of hypoglycaemia familiar to the patient and managed solely by the patient. Events of severe hypoglycaemia are defined as episodes with symptoms of hypoglycaemia with need for assistance from another person.

  3. Plasma concentrations of insulin and C-peptide

    Time frame · 14 weeks

    Registry description

    Postprandial responses of incretin hormones and beta cell function (assessed as fasting proinsulin-to-insulin ratio) will be evaluated during three standardised 4-hour meal tests (at baseline and in the end of each treatment period).

  4. Plasma glucagon

    Time frame · 14 weeks

    Registry description

    Postprandial responses of incretin hormones and beta cell function (assessed as fasting proinsulin-to-insulin ratio) will be evaluated during three standardised 4-hour meal tests (at baseline and in the end of each treatment period).

  5. Plasma concentrations of incretin hormones

    Time frame · 14 weeks

    Registry description

    Postprandial responses of incretin hormones and beta cell function (assessed as fasting proinsulin-to-insulin ratio) will be evaluated during three standardised 4-hour meal tests (at baseline and in the end of each treatment period).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2014

5 results

Glucose-lowering effects and low risk of hypoglycemia in patients with maturity-onset diabetes of the young when treated with a GLP-1 receptor agonist: a double-blind, randomized, crossover trial.

Østoft et al. 2014Diabetes carecited by 106

PMID 24929431DOI 10.2337/dc13-3007PUB-24929431

Full text at the publisher5 results
Publisher pageSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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