- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03017352
Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases (MAG1C)
Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetic Cases: A Randomised, Placebo-controlled Trial
Patients with type 1 diabetes (T1D) depend on insulin therapy as substitution for the lack of endocrine insulin production due to an autoimmune destruction of beta-cells in the pancreatic inslets. Insulin therapy is based on long lasting basal insulin for controlling fasting plasma glucose, and short lasting mealtime insulin for the postprandial plasma glucose. The long term efficacy of this treatment is measured in glycated haemoglobin A1c (HbA1c) of <7.0% as the treatment goal.
Intensive insulin therapy is associated with side effects such as hypoglycaemia, weight gain, and unwanted exaggerated excursions in PPG. This may ultimately affect treatment compliance.
The abovementioned problems associated with insulin treatment in T1D can also be seen in insulin-treated patients with type 2 diabetes (T2D). However, in T2D the combination of insulin with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) has proven effective in reducing the weight gain and insulin dose in insulin-treated patients with T2D without exacerbating the risk of hypoglycaemia.
Exenatid is a short lasting GLP-1RA approved for treatment in T2D, and the investigators intend to evaluate it in a randomized, controlled trial as add-on therapy to standard insulin therapy for patients with T1D.
The investigators hypothesise that the add-on of exenatide to insulin therapy in patients with T1D will reduce insulin requirements, glycaemic excursions and body weight and improve glycaemic control without increasing the risk of hypoglycaemia.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Capital Region
-
Gentofte, Capital Region, Danmark, 2820
- Steno Diabetes Center Copenhagen
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- T1D according to WHO criteria with duration of ≥1 year
- Age ≥18 years
- BMI >22.0 kg/m2
- HbA1c >7.5% and <10.0% at visit 0 (screening)
- Able to count carbohydrates
Exclusion Criteria:
- Insulin pump treatment
- Hypoglycaemia unawareness (inability to register low blood glucose)
- Diabetic gastroparesis
- Compromised kidney function (eGFR <60 ml/min/1.73m2, dialysis or kidney transplantation)
- Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
- History of acute and/or chronic pancreatitis
- Subjects with personal or family history of medullary carcinoma or MEN syndrome
- Inflammatory bowel disease
- Cancer unless in complete remission for >5 years
- Proliferative retinopathy
- Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
- Alcohol/drug abuse
- Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives
- Pregnant or nursing women
- Known or suspected hypersensitivity to trial product or related products
- Receipt of an investigational drug within 30 days prior to visit 0
- Simultaneous participation in any other clinical intervention trial
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Intervention
Exenatide 10 mikrogram, thrice daily, subcutaneous injection prior to main meals, 6 months.
|
Andra namn:
|
Placebo-jämförare: Placebo
Placebo, thrice daily, subcutaneous injection prior to main meals, 6 months.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in HbA1c
Tidsram: 6 months
|
Change in HbA1c from baseline to end of study (time 6 months)
|
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
adverse events (including hypoglycaemic episodes)
Tidsram: 6 months
|
6 months
|
|
changes in insulin dosage
Tidsram: 6 months
|
6 months
|
|
changes in body weight
Tidsram: 6 months
|
6 months
|
|
changes in BMI
Tidsram: 6 months
|
6 months
|
|
changes in body composition
Tidsram: 6 months
|
DXA scan measuring bonemineral density
|
6 months
|
changes in body composition
Tidsram: 6 months
|
DXA scan measuring lean mass
|
6 months
|
changes in body composition
Tidsram: 6 months
|
DXA scan measuring fat mass
|
6 months
|
changes in fasting plasma glucose
Tidsram: 6 months
|
6 months
|
|
changes in post prandial plasma glucose
Tidsram: 6 months
|
6 months
|
|
changes in fasting plasma levels of C-peptide
Tidsram: 6 months
|
6 months
|
|
Quality of life self reported
Tidsram: 6 months
|
Quality of Life Questionaire
|
6 months
|
Treatment satisfaction
Tidsram: 6 months
|
Diabetes treatment satisfactory questionnaire status version
|
6 months
|
Treatment satisfaction
Tidsram: 6 months
|
Diabetes treatment satisfactory questionnaire change version
|
6 months
|
dietary patterns
Tidsram: 6 months
|
Food frequency questionaire three times during the intervention
|
6 months
|
HDL (High Density Lipoprotein)
Tidsram: 6 months
|
6 months
|
|
LDL (Low Density Lipoprotein)
Tidsram: 6 months
|
6 months
|
|
VLDL (Very Low Density Lipoprotein)
Tidsram: 6 months
|
6 months
|
|
totalt kolesterol
Tidsram: 6 månader
|
6 månader
|
|
triglycerides
Tidsram: 6 months
|
6 months
|
|
proBNP (Pro-Brain Natriuretic Peptide)
Tidsram: 6 months
|
6 months
|
|
hsCRP (High-Sensitivity C-Reactive Protein)
Tidsram: 6 months
|
6 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Allmänna publikationer
- Johansen NJ, Dejgaard TF, Lund A, Vilsboll T, Andersen HU, Knop FK. Protocol for Meal-time Administration of Exenatide for Glycaemic Control in Type 1 Diabetes Cases (The MAG1C trial): a randomised, double-blinded, placebo-controlled trial. BMJ Open. 2018 Jun 27;8(6):e021861. doi: 10.1136/bmjopen-2018-021861.
- Johansen NJ, Dejgaard TF, Lund A, Schluntz C, Frandsen CS, Forman JL, Wewer Albrechtsen NJ, Holst JJ, Pedersen-Bjergaard U, Madsbad S, Vilsboll T, Andersen HU, Knop FK. Efficacy and safety of meal-time administration of short-acting exenatide for glycaemic control in type 1 diabetes (MAG1C): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2020 Apr;8(4):313-324. doi: 10.1016/S2213-8587(20)30030-9. Epub 2020 Mar 2.
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 (Faktisk)
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
- Medel mot fetma
- Inkretiner
- Exenatid
Andra studie-ID-nummer
- Eudract-nr.: 2016-001365-92
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Diabetes mellitus, typ 1
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.AvslutadDiabetes mellitus, typ 1 | Typ 1-diabetes | Diabetes typ 1 | Typ 1-diabetes mellitus | Autoimmun diabetes | Diabetes mellitus, insulinberoende | Ungdomsdiabetes | Diabetes, autoimmun | Insulinberoende diabetes mellitus 1 | Diabetes mellitus, insulinberoende, 1 | Diabetes mellitus, spröd | Diabetes mellitus, juvenil-debut och andra villkorFörenta staterna
-
University of California, San FranciscoJuvenile Diabetes Research FoundationAvslutadTyp 1-diabetes mellitus | Diabetes mellitus, typ I | Insulinberoende diabetes mellitus 1 | Diabetes mellitus, insulinberoende, 1 | IDDMFörenta staterna, Australien
-
Capillary Biomedical, Inc.AvslutadDiabetes mellitus, typ 1 | Typ 1-diabetes | Typ 1-diabetes mellitus | Diabetes mellitus, insulinberoende, 1Australien
-
SanofiAvslutadTyp 1-diabetes mellitus-typ 2-diabetes mellitusUngern, Ryska Federationen, Tyskland, Polen, Japan, Förenta staterna, Finland
-
Hanmi Pharmaceutical Company LimitedOkändTyp 2 diabetes mellitus | Typ 1 diabetes mellitusFörenta staterna
-
Joslin Diabetes CenterCambridge Medical Technologies, LLCAvslutadTyp 2-diabetes mellitus | Typ 1 diabetes mellitusFörenta staterna
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)AvslutadTyp 1-diabetes mellitus | T1DM | T1D | Nyuppkommen typ 1-diabetes mellitusFörenta staterna, Australien
-
Spiden AGDCB Research AGAvslutadTyp 1-diabetes mellitus | Typ 1-diabetes mellitus med hypoglykemi | Typ 1-diabetes mellitus med hyperglykemiSchweiz
-
AstraZenecaAvslutadTyp 2-diabetes mellitus | Typ 1-diabetes mellitusFörenta staterna
-
HealthCore-NERIYale UniversityAvslutadTyp 1 diabetes | Typ 1 diabetes mellitusFörenta staterna
Kliniska prövningar på Placebo
-
SamA Pharmaceutical Co., LtdOkändAkut bronkit | Akut övre luftvägsinfektionKorea, Republiken av
-
National Institute on Drug Abuse (NIDA)AvslutadAnvändning av cannabisFörenta staterna
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyAvslutadManliga försökspersoner med typ II-diabetes (T2DM)Tyskland
-
Heptares Therapeutics LimitedAvslutadFarmakokinetik | SäkerhetsfrågorStorbritannien
-
Texas A&M UniversityNutraboltAvslutadGlucose and Insulin Response
-
Longeveron Inc.AvslutadHypoplastiskt vänsterhjärtsyndromFörenta staterna
-
Regado Biosciences, Inc.AvslutadFrisk volontärFörenta staterna
-
ItalfarmacoAvslutadBeckers muskeldystrofiNederländerna, Italien
-
Universidade Estadual de LondrinaConselho Nacional de Desenvolvimento Científico e Tecnológico; Coordination...AvslutadVassleproteintillskott associerat med motståndsträning på hälsoindikatorer hos tränade äldre kvinnorFriska | Kroppssammansättning