search
Back to results

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

Primary Purpose

Adult Subjects With Type1Diabetes and Insulin Microsecretion

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Dulaglutide
Placebo
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Subjects With Type1Diabetes and Insulin Microsecretion focused on measuring type 1 diabetes, insulin microsecretion, dulaglutide, randomized, double-blind placebo-controlled trial

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service d'Endocrinologie, Maladies Métaboliques et Nutrition, CHU Grenoble, Hopital de la Tronche
  • Département d''Endocrinologie, Diabétologie, Nutrition ; CHU Montpellier ; Hôpital Lapeyronie, Avenue du Doyen Giraud
  • Service d'Endocrinologie, Maladies Métaboliques et Nutrition,CHU Nantes,Hôpital Nord Laennec,Bd Jacques-Monod,Saint-Herblain
  • Service de Diabétologie et Maladies Métaboliques, Assistance Publique des Hôpitaux de Paris ;Hôpital Cochin, 27 rue du Faubourg Saint-Jacques
  • Service d'Endocrinologie, Diabétologie, Maladies de la Nutrition, Hospices Civils de Lyon, Centre hospitalier Lyon-Sud
  • Service de Diabétologie Maladies Métaboliques et Nutrition ; CHU Toulouse, Pôle cardiovasculaire et métabolique, Hôpital Rangueil ; 1, avenue du Professeur Jean Poulhès - TSA 50032
  • Service de Diabétologie, Maladies Métaboliques, Nutrition ; CHU Nancy ; Technopôle Nancy-Brabois ; Rue du Morvan,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dulaglutide

placebo

Arm Description

Experimental group receiving 1.5 mg Dulaglutide subcutaneously weekly in addition to their usual insulin regimen during 24 weeks

Control group receiving placebo subcutaneously weekly in addition to their usual insulin regimen during 24 weeks

Outcomes

Primary Outcome Measures

HbA1c level
Blood level

Secondary Outcome Measures

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)
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
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
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.
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
: Body weight
% carbohydrates
Evaluate and compare the changes in mean carbohydrate intake during the run-in period and after 24 weeks with Dulaglutide vs placebo
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
Number of adverse events
Evaluation and comparison the number of adverse events with Dulaglutide vs placebo during the study
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
insulin doses : basal/ prandial ratio
the insulin basal/ prandial ratio
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
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
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 .

Full Information

First Posted
September 11, 2018
Last Updated
July 7, 2021
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT03668470
Brief Title
Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes
Acronym
DIAMOND GLP1
Official Title
Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes : A Randomized Double-blind Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
February 3, 2021 (Actual)
Study Completion Date
February 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Subjects With Type1Diabetes and Insulin Microsecretion
Keywords
type 1 diabetes, insulin microsecretion, dulaglutide, randomized, double-blind placebo-controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dulaglutide
Arm Type
Experimental
Arm Description
Experimental group receiving 1.5 mg Dulaglutide subcutaneously weekly in addition to their usual insulin regimen during 24 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Control group receiving placebo subcutaneously weekly in addition to their usual insulin regimen during 24 weeks
Intervention Type
Drug
Intervention Name(s)
Dulaglutide
Intervention Description
Dulaglutide 1.5mg : One injection per week during 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo: one injection per week during 24 weeks
Primary Outcome Measure Information:
Title
HbA1c level
Description
Blood level
Time Frame
after 24 weeks of treatment
Secondary Outcome Measure Information:
Title
AUC us C-peptide following a MMT
Description
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)
Time Frame
before and after 24 weeks of treatment
Title
Glucagon levels fasting and following a MMT
Description
Evaluation and comparison before and after 24wks of treatment with Dulaglutide vs placebo AUC glucagon from 6 values on fasting and after MMT
Time Frame
before and after 24 weeks of treatment
Title
AUC us C-peptide over AUC blood glucose levels following a MMT
Description
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
Time Frame
before and after 24 weeks of treatment
Title
Daily percent times spent with continuous glucose measurements (CGM) readings between 4 and 10mmol/l, above and below this range
Description
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.
Time Frame
the run-in period (1 month) and after 24 weeks of treatment
Title
Daily insulin doses and basal/ prandial ratio
Description
Evaluation and comparison before and after 24wks of treatment with Dulaglutide vs placebo the daily insulin doses and basal/ prandial ratio
Time Frame
: before and after 24weeks of treatment
Title
: Body weight
Time Frame
before and after 24weeks of treatment
Title
% carbohydrates
Description
Evaluate and compare the changes in mean carbohydrate intake during the run-in period and after 24 weeks with Dulaglutide vs placebo
Time Frame
the run-in period (1 month) and after 24 weeks of treatment
Title
Number of symptomatic hypoglycemic episodes
Description
Evaluation and comparison the number of symptomatic (both minor and severe) hypoglycemic episodes with Dulaglutide vs placebo during the study
Time Frame
20 months
Title
Number of adverse events
Description
Evaluation and comparison the number of adverse events with Dulaglutide vs placebo during the study
Time Frame
20 months
Title
Autoantibodies to GAD65
Description
Evaluation and comparison before and after 24wks of treatment the levels and subtypes of autoantibodies associated with T1D with and without dulaglutide
Time Frame
: before and after 24wks of treatment
Title
insulin doses : basal/ prandial ratio
Description
the insulin basal/ prandial ratio
Time Frame
before and after 24weeks of treatment
Title
Autoantibodies to IA-2
Description
Evaluation and comparison before and after 24wks of treatment the levels and subtypes of autoantibodies associated with T1D with and without dulaglutide
Time Frame
before and after 24wks of treatment
Title
Autoantibodies to ZnT8
Description
Evaluation and comparison before and after 24wks of treatment the levels and subtypes of autoantibodies associated with T1D with and without dulaglutide
Time Frame
before and after 24wks of treatment
Title
coefficients of variation (CV)
Description
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 .
Time Frame
the run-in period (1 month) and after 24 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles THIVOLET
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Endocrinologie, Maladies Métaboliques et Nutrition, CHU Grenoble, Hopital de la Tronche
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Département d''Endocrinologie, Diabétologie, Nutrition ; CHU Montpellier ; Hôpital Lapeyronie, Avenue du Doyen Giraud
City
Montpellier 5
ZIP/Postal Code
34295
Country
France
Facility Name
Service d'Endocrinologie, Maladies Métaboliques et Nutrition,CHU Nantes,Hôpital Nord Laennec,Bd Jacques-Monod,Saint-Herblain
City
NANTES cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Service de Diabétologie et Maladies Métaboliques, Assistance Publique des Hôpitaux de Paris ;Hôpital Cochin, 27 rue du Faubourg Saint-Jacques
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Service d'Endocrinologie, Diabétologie, Maladies de la Nutrition, Hospices Civils de Lyon, Centre hospitalier Lyon-Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Service de Diabétologie Maladies Métaboliques et Nutrition ; CHU Toulouse, Pôle cardiovasculaire et métabolique, Hôpital Rangueil ; 1, avenue du Professeur Jean Poulhès - TSA 50032
City
TOULOUSE cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Service de Diabétologie, Maladies Métaboliques, Nutrition ; CHU Nancy ; Technopôle Nancy-Brabois ; Rue du Morvan,
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes

We'll reach out to this number within 24 hrs