| Trial ID: | L5285 |
| Source ID: | NCT03668470
|
| Associated Drug: |
Dulaglutide
|
| Title: |
Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes
|
| Acronym: |
DIAMOND GLP1
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Adult Subjects With Type1Diabetes and Insulin Microsecretion
|
| Interventions: |
DRUG: Dulaglutide|DRUG: Placebo
|
| Outcome Measures: |
Primary: HbA1c level, Blood level, after 24 weeks of treatment | Secondary: AUC us C-peptide following a MMT, Evaluation and comparison before and after 24wks of treatment with Dulaglutide vs placebo the area under curve (AUC) of ultrasensitive (us) C-peptide response from 6 values following a mixed meal test (MMT), before and after 24 weeks of treatment|Glucagon levels fasting and following a MMT, Evaluation and comparison before and after 24wks of treatment with Dulaglutide vs placebo AUC glucagon from 6 values on fasting and after MMT, before and after 24 weeks of treatment|AUC us C-peptide over AUC blood glucose levels following a MMT, Evaluation and comparison the ratio of the area under curve (AUC) of us C-peptide over the glucose response following a mixed meal test (MMT) with before and after 24 weeks of treatment Dulaglutide vs placebo, before and after 24 weeks of treatment|Daily percent times spent with continuous glucose measurements (CGM) readings between 4 and 10mmol/l, above and below this range, Evaluation and comparison the changes in the daily percent time spent with continuous glucose measurements (CGM) readings between 4 and 10mmol/l during the run-in period (1 month) and after 24 weeks with Dulaglutide vs placebo, coefficients of variation (CV) and standard deviation values (SD) as well as the average daily risk change (ADRR) of glucose values to assess blood glucose variability., the run-in period (1 month) and after 24 weeks of treatment|Daily insulin doses and basal/ prandial ratio, Evaluation and comparison before and after 24wks of treatment with Dulaglutide vs placebo the daily insulin doses and basal/ prandial ratio, : before and after 24weeks of treatment|: Body weight, before and after 24weeks of treatment|% carbohydrates, Evaluate and compare the changes in mean carbohydrate intake during the run-in period and after 24 weeks with Dulaglutide vs placebo, the run-in period (1 month) and after 24 weeks of treatment|Number of symptomatic hypoglycemic episodes, Evaluation and comparison the number of symptomatic (both minor and severe) hypoglycemic episodes with Dulaglutide vs placebo during the study, 20 months|Number of adverse events, Evaluation and comparison the number of adverse events with Dulaglutide vs placebo during the study, 20 months|Autoantibodies to GAD65, Evaluation and comparison before and after 24wks of treatment the levels and subtypes of autoantibodies associated with T1D with and without dulaglutide, : before and after 24wks of treatment|insulin doses : basal/ prandial ratio, the insulin basal/ prandial ratio, before and after 24weeks of treatment|Autoantibodies to IA-2, Evaluation and comparison before and after 24wks of treatment the levels and subtypes of autoantibodies associated with T1D with and without dulaglutide, before and after 24wks of treatment|Autoantibodies to ZnT8, Evaluation and comparison before and after 24wks of treatment the levels and subtypes of autoantibodies associated with T1D with and without dulaglutide, before and after 24wks of treatment|coefficients of variation (CV), coefficients of variation (CV) of daily percent times spent with continuous glucose measurements (CGM) readings between 4 and 10mmol/l, above and below this range ., the run-in period (1 month) and after 24 weeks of treatment
|
| Sponsor/Collaborators: |
Sponsor: Hospices Civils de Lyon
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
45
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-01-31
|
| Completion Date: |
2021-02-03
|
| Results First Posted: |
|
| Last Update Posted: |
2021-07-08
|
| Locations: |
Service d'Endocrinologie, Maladies Métaboliques et Nutrition, CHU Grenoble, Hopital de la Tronche, La Tronche, 38700, France|Département d''Endocrinologie, Diabétologie, Nutrition ; CHU Montpellier ; Hôpital Lapeyronie, Avenue du Doyen Giraud, Montpellier 5, 34295, France|Service d'Endocrinologie, Maladies Métaboliques et Nutrition,CHU Nantes,Hôpital Nord Laennec,Bd Jacques-Monod,Saint-Herblain, NANTES cedex 1, 44093, France|Service de Diabétologie et Maladies Métaboliques, Assistance Publique des Hôpitaux de Paris ;Hôpital Cochin, 27 rue du Faubourg Saint-Jacques, Paris, 75014, France|Service d'Endocrinologie, Diabétologie, Maladies de la Nutrition, Hospices Civils de Lyon, Centre hospitalier Lyon-Sud, Pierre-Bénite, 69495, France|Service de Diabétologie Maladies Métaboliques et Nutrition ; CHU Toulouse, Pôle cardiovasculaire et métabolique, Hôpital Rangueil ; 1, avenue du Professeur Jean Poulhès - TSA 50032, TOULOUSE cedex 9, 31059, France|Service de Diabétologie, Maladies Métaboliques, Nutrition ; CHU Nancy ; Technopôle Nancy-Brabois ; Rue du Morvan,, Vandœuvre-lès-Nancy, 54500, France
|
| URL: |
https://clinicaltrials.gov/show/NCT03668470
|
