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Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes (DIAMOND GLP1)

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ClinicalTrials.gov Identifier: NCT03668470
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Some patients with type 1 diabetes (T1D) can still have some remaining insulin-positive cells in the pancreas and secrete little amounts of insulin. Despite the presence of residual beta cells, the HbA1C levels remain at high levels due to functional defects of insulin secretion associated with glucotoxicity. Previous trials have indicated that treatment with a Glucagon-like peptide 1 (GLP-1 )receptor agonist in T1D with some residual beta-cell function might improve glycemic control, reduce dose of insulin and risk of hypoglycemia.

The general hypothesis of DIAMOND-GLP1 is that GLP1-R agonists will improve blood glucose

After initial screening to select insulin microsecretors and a run-in period of one month, patients will be randomized into two arms and followed in parallel for 24 weeks :

  • Experimental group receiving 1.5 mg Dulaglutide s.c weekly in addition to their usual insulin regimen
  • Control group receiving placebo s.c weekly in addition to their usual insulin regimen.

The primary endpoint is HbA1c value at 24 weeks


Condition or disease Intervention/treatment Phase
Adult Subjects With Type1Diabetes and Insulin Microsecretion Drug: Dulaglutide Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicentric, investigator-initiated, randomized, double-blinded, therapeutic clinical trial, placebo-controlled, two arm parallel group intervention trial during 24 weeks, phase II.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes : A Randomized Double-blind Placebo-controlled Trial
Actual Study Start Date : January 31, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Dulaglutide
Experimental group receiving 1.5 mg Dulaglutide subcutaneously weekly in addition to their usual insulin regimen during 24 weeks
Drug: Dulaglutide
Dulaglutide 1.5mg : One injection per week during 24 weeks

Placebo Comparator: placebo
Control group receiving placebo subcutaneously weekly in addition to their usual insulin regimen during 24 weeks
Drug: Placebo
Placebo: one injection per week during 24 weeks




Primary Outcome Measures :
  1. HbA1c level [ Time Frame: after 24 weeks of treatment ]
    Blood level


Secondary Outcome Measures :
  1. AUC us C-peptide following a MMT [ Time Frame: before and after 24 weeks of treatment ]
    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)

  2. Glucagon levels fasting and following a MMT [ Time Frame: before and after 24 weeks of treatment ]
    Evaluation and comparison before and after 24wks of treatment with Dulaglutide vs placebo AUC glucagon from 6 values on fasting and after MMT

  3. AUC us C-peptide over AUC blood glucose levels following a MMT [ Time Frame: before and after 24 weeks of treatment ]
    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

  4. Daily percent times spent with continuous glucose measurements (CGM) readings between 4 and 10mmol/l, above and below this range [ Time Frame: the run-in period (1 month) and after 24 weeks of treatment ]
    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.

  5. Daily insulin doses and basal/ prandial ratio [ Time Frame: : before and after 24weeks of treatment ]
    Evaluation and comparison before and after 24wks of treatment with Dulaglutide vs placebo the daily insulin doses and basal/ prandial ratio

  6. : Body weight [ Time Frame: before and after 24weeks of treatment ]
  7. % carbohydrates [ Time Frame: the run-in period (1 month) and after 24 weeks of treatment ]
    Evaluate and compare the changes in mean carbohydrate intake during the run-in period and after 24 weeks with Dulaglutide vs placebo

  8. Number of symptomatic hypoglycemic episodes [ Time Frame: 20 months ]
    Evaluation and comparison the number of symptomatic (both minor and severe) hypoglycemic episodes with Dulaglutide vs placebo during the study

  9. Number of adverse events [ Time Frame: 20 months ]
    Evaluation and comparison the number of adverse events with Dulaglutide vs placebo during the study

  10. Autoantibodies to GAD65 [ Time Frame: : before and after 24wks of treatment ]
    Evaluation and comparison before and after 24wks of treatment the levels and subtypes of autoantibodies associated with T1D with and without dulaglutide

  11. insulin doses : basal/ prandial ratio [ Time Frame: before and after 24weeks of treatment ]
    the insulin basal/ prandial ratio

  12. Autoantibodies to IA-2 [ Time Frame: before and after 24wks of treatment ]
    Evaluation and comparison before and after 24wks of treatment the levels and subtypes of autoantibodies associated with T1D with and without dulaglutide

  13. Autoantibodies to ZnT8 [ Time Frame: before and after 24wks of treatment ]
    Evaluation and comparison before and after 24wks of treatment the levels and subtypes of autoantibodies associated with T1D with and without dulaglutide

  14. coefficients of variation (CV) [ Time Frame: the run-in period (1 month) and after 24 weeks of treatment ]
    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 .



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with T1D> 4years, with age range 20-60years
  • Diabetes onset after the age of 15years
  • Duration of diabetes <15 years
  • Treated with continuous sub-cutaneous insulin infusions (CSI) or multiple daily injections of insulin (MDI)
  • Measuring their blood sugar at least four times daily
  • Glycated hemoglobin (HbA1C) at screening >7 and <10%
  • 16.0 kg/m2 <BMI<30.0kg/m2
  • Patients with childbearing potential should use effective contraception, defined as methods with a failure rate ≤ 2 % per year (OMS 2011) during the study.
  • Patients who gave its written informed consent to participate to the study
  • Patients affiliated to a social insurance regime

Randomization criteria:

Patients with fasting ultra-sensitive (us) C-peptide above 15pmol/l

Exclusion Criteria:

  • Patients are not eligible for this study if any of the following exclusion criteria apply:
  • Patients with type 2 diabetes (T2D)
  • Hypersensitivity to dulaglutide and/or any of its excipients
  • Subjects with history of severe hypoglycemia or recent (< 6 months) history of diabetic ketoacidosis
  • History of gastrointestinal disease with prolonged (> 3 months) nausea or vomiting, liver or kidney diseases, pancreatitis, thyroid medullary cancer or familial history of multiple endocrine neoplasia type 2
  • Estimated glomerular filtration rate<60ml/min/ 1.73m2 (CKD-EPI method)
  • Congestive heart failure
  • Any uncontrolled disease, cancers essentially
  • Chronic use of paracetamol containing products, which may falsely raise sensor glucose readings
  • Use of tricyclic antidepressant, selective serotonin reuptake inhibitor, triptans, neuroleptic drugs and glucocorticoid.
  • Patient who participated in another clinical trial on experimental drug in the previous 30 days
  • Patients of childbearing potential who are not using adequate contraception; Female patients who are pregnant or lactating.
  • Gastric bypass surgery
  • Patients under guardianship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668470


Contacts
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Contact: Charles THIVOLET +33 4 78 86 14 87 charles.thivolet@chu-lyon.fr

Locations
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France
Service d'Endocrinologie, Maladies Métaboliques et Nutrition, CHU Grenoble, Hopital de la Tronche Not yet recruiting
La Tronche, France, 38700
Contact: Pierre-Yves BENHAMOU    +33 4 76 76 55 09    PYBenhamou@chu-grenoble.fr   
Principal Investigator: Pierre-Yves BENHAMOU         
Sub-Investigator: Sandrine LABLANCHE         
Département d''Endocrinologie, Diabétologie, Nutrition ; CHU Montpellier ; Hôpital Lapeyronie, Avenue du Doyen Giraud Recruiting
Montpellier 5, France, 34295
Contact: Eric RENARD    +33 4 67 33 83 82    e-renard@chu-montpellier.fr   
Principal Investigator: Eric RENARD         
Sub-Investigator: Anne WOJTUSCISZYN         
Service d'Endocrinologie, Maladies Métaboliques et Nutrition,CHU Nantes,Hôpital Nord Laennec,Bd Jacques-Monod,Saint-Herblain Recruiting
NANTES cedex 1, France, 44093
Contact: Bertrand CARIOU    +33 2 53 48 27 01    bertrand.cariou@univ-nantes.fr   
Principal Investigator: Bertrand CARIOU         
Sub-Investigator: Lucy CHAILLOUS         
Service de Diabétologie et Maladies Métaboliques, Assistance Publique des Hôpitaux de Paris ;Hôpital Cochin, 27 rue du Faubourg Saint-Jacques Recruiting
Paris, France, 75014
Contact: Etienne LARGER    +33 1 58 41 19 19    etienne.larger@cch.aphp.fr   
Principal Investigator: Etienne LARGER         
Service d'Endocrinologie, Diabétologie, Maladies de la Nutrition, Hospices Civils de Lyon, Centre hospitalier Lyon-Sud Recruiting
Pierre-Bénite, France, 69495
Contact: Charles THIVOLET    +33 4 78 86 14 87    charles.thivolet@chu-lyon.fr   
Principal Investigator: Charles THIVOLET         
Sub-Investigator: Lucien MARCHAND         
Service de Diabétologie Maladies Métaboliques et Nutrition ; CHU Toulouse, Pôle cardiovasculaire et métabolique, Hôpital Rangueil ; 1, avenue du Professeur Jean Poulhès - TSA 50032 Recruiting
TOULOUSE cedex 9, France, 31059
Contact: Hélène HANAIRE    : +33 5 61 32 30 18    hanaire.h@chu-toulouse.fr   
Principal Investigator: Hélène HANAIRE         
Service de Diabétologie, Maladies Métaboliques, Nutrition ; CHU Nancy ; Technopôle Nancy-Brabois ; Rue du Morvan, Not yet recruiting
Vandœuvre-lès-Nancy, France, 54500
Contact: Bruno GUERCI    +33 3 83 65 65 28    b.guerci@chu-nancy.fr   
Principal Investigator: Bruno GUERCI         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Charles THIVOLET Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03668470    
Other Study ID Numbers: 69HCL18_0047
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
type 1 diabetes
insulin microsecretion
dulaglutide
randomized
double-blind placebo-controlled trial
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Dulaglutide
Immunoglobulin Fc Fragments
Hypoglycemic Agents
Physiological Effects of Drugs
Immunologic Factors