The Effects of GLP-1 in Maturity-Onset Diabetes of The Young (MODY)
|ClinicalTrials.gov Identifier: NCT01610934|
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : September 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Maturity-onset Diabetes of the Young||Drug: liraglutide Drug: Glimepiride||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 2 Study: A Double-blind, Randomised, Clinical Cross-over Trial to Investigate the Treatment Potential of Liraglutide Compared to Glimepiride in MODY Patients|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
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.
Other Name: Victoza®
|Active Comparator: 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.
Other Name: Amaryl®
- Fasting Plasma Glucose [ Time Frame: 14 weeks ]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.
- Serum Fructosamine [ Time Frame: 14 weeks ]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).
- Hypoglycemic events [ Time Frame: 14 weeks ]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.
- Plasma concentrations of insulin and C-peptide [ Time Frame: 14 weeks ]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).
- Plasma glucagon [ Time Frame: 14 weeks ]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).
- Plasma concentrations of incretin hormones [ Time Frame: 14 weeks ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610934
|Diabetes research Division, University Hospital Gentofte|
|Hellerup, Denmark, 2900|
|Principal Investigator:||Signe H Østoft, MD||Diabetes Research Division, University Hospital Gentofte, Denmark|