| Trial ID: | L3461 |
| Source ID: | NCT01610934
|
| Associated Drug: |
Liraglutide
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| Title: |
The Effects of GLP-1 in Maturity-Onset Diabetes of The Young (MODY)
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Maturity-onset Diabetes of the Young
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| Interventions: |
DRUG: liraglutide|DRUG: Glimepiride
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| Outcome Measures: |
Primary: Fasting Plasma Glucose, 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., 14 weeks | Secondary: Serum Fructosamine, 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)., 14 weeks|Hypoglycemic events, 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., 14 weeks|Plasma concentrations of insulin and C-peptide, 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)., 14 weeks|Plasma glucagon, 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)., 14 weeks|Plasma concentrations of incretin hormones, 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)., 14 weeks
|
| Sponsor/Collaborators: |
Sponsor: University Hospital, Gentofte, Copenhagen | Collaborators: Novo Nordisk A/S|University of Copenhagen
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2|PHASE3
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| Enrollment: |
15
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-08
|
| Completion Date: |
2013-08
|
| Results First Posted: |
|
| Last Update Posted: |
2013-09-05
|
| Locations: |
Diabetes research Division, University Hospital Gentofte, Hellerup, 2900, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT01610934
|
