- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02092896
Liraglutide as add-on to Insulin in Type 1 Diabetes (T1DMLIRA)
Treatment With Liraglutide as add-on to Insulin in Type 1 Diabetic Patients. Effects on Glycemic Control and Counterregulation and Cognitive Performance During Hypoglycaemia
The purpose of this study is to:
Part 1:
To investigate how 12 weeks treatment with liraglutide affects glycemic control in poorly controlled patients and how the treatment affects gastric emptying rate during hypoglycemia.
Part 2:
To investigate how 12 weeks treatment of type 1 diabetic patients with liraglutide affects counterregulatory hormones and cognitive performance during hypoglycemia.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
Copenhagen
-
Hvidovre, Copenhagen, Danmark, 2650
- Dept. of Endocrinology, Hvidovre University Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age: 18-70 years
- BMI: 18-28
- HbA1c ≥ 8 %
- No residual β-cell function (glucagon test with c-peptide < 60 pM)
- Caucasian
- Diagnosed with type 1 diabetes at 5 to 40 years of age (both inclusive).
- Remission phase must be completed
- Female participants must use adequate contraception
- Informed consent
Exclusion Criteria:
- Overt diabetes complications; creatinin > 130 µM, proliferative retinopathy, macroalbuminuria.
- Autonomic neuropathy (RR-variation </=10 beats/min) and/or Orthostatic hypotension (OH).
- Anemia, Hb concentration; female <7.0 mmol/l, male<8.0 mmol/l
- Pregnancy or lactation
- Epilepsy
- Use of antiepileptic medication
- Use of beta blockers
- Previously apoplexy cerebri.
- Any use of benzodiazepine within the last month
- Any use of neuroleptic drugs within the last six months
- Self-perceived hearing loss
- Alcohol or drug abuse
- Allergy to the medication or placebo.
- Treatment with any medication affecting glucose metabolism.
- Any disorder which in the investigators opinion could interfere with the safety and results of the trial
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: Placebo + Insulin + Study 2
Study 2: Cognitive performance test
|
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks.
At baseline and week 12 study 1 is performed.
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks.
At baseline and week 12 study 2 is performed.
|
Experimentell: Liraglutide + Insulin + Study 2
Study 2: Cognitive performance test
|
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks.
At baseline and week 12 study 1 is performed.
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks.
At baseline and week 12 study 2 is performed.
|
Experimentell: Liraglutide + Insulin + Study 1
Study 1: Gastric emptying test
|
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks.
At baseline and week 12 study 1 is performed.
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks.
At baseline and week 12 study 2 is performed.
|
Placebo-jämförare: Placebo + Insulin + Study 1
Study 1: Gastric emptying test
|
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks.
At baseline and week 12 study 1 is performed.
Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks.
At baseline and week 12 study 2 is performed.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Change from baseline in HbA1c (glycosylated haemoglobin)
Tidsram: Week 0, week 12
|
Week 0, week 12
|
Changes from baseline in EEG and cognitive performances
Tidsram: week 0, week 12
|
week 0, week 12
|
Change from baseline in gastric emptying rate
Tidsram: week 0, week 12
|
week 0, week 12
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Change from baseline in glycemic control (CGM)
Tidsram: week 0, week 12
|
week 0, week 12
|
Change from baseline in total daily insulin dose
Tidsram: week 0, week 12
|
week 0, week 12
|
Changes from baseline in the counterregulatory hormone responses during hypoglycemia
Tidsram: week 0, week 12
|
week 0, week 12
|
Change from baseline in body weight
Tidsram: week 0, week 12
|
week 0, week 12
|
Change from baseline in auditory evoked potentials (AEP) during hypoglycemia
Tidsram: week 0, week 12
|
week 0, week 12
|
Change from baseline in corrected QTc-interval (QTc) during hypoglycemia
Tidsram: week 0, week 12
|
week 0, week 12
|
Change from baseline in hypoglycemic symptom score
Tidsram: week 0, week 12
|
week 0, week 12
|
Andra resultatmått
Resultatmått |
Tidsram |
---|---|
Frequency of Hypoglycemic episodes
Tidsram: Week 0, week 12
|
Week 0, week 12
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Christian SS Frandsen, MD, Hvidovre University Hospital
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Störningar i glukosmetabolism
- Metaboliska sjukdomar
- Immunsystemets sjukdomar
- Autoimmuna sjukdomar
- Sjukdomar i det endokrina systemet
- Diabetes mellitus
- Diabetes mellitus, typ 1
- Hypoglykemiska medel
- Läkemedels fysiologiska effekter
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Inkretiner
- Liraglutid
Andra studie-ID-nummer
- 2012-002526-67 (EudraCT-nummer)
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