Adult Subjects With Type1Diabetes and Insulin MicrosecretionPhase 2DIAMOND GLP1NCT03668470
Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes
A Phase 2 study testing Dulaglutide in people with Adult Subjects With Type1Diabetes and Insulin Microsecretion, run by Hospices Civils de Lyon at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Adult Subjects With Type1Diabetes and Insulin Microsecretion
- What is being tested?
- Dulaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 7 sitesFrance
- Study dates
- 31 Jan 2019to 3 Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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%
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Service d'Endocrinologie, Maladies Métaboliques et Nutrition, CHU Grenoble, Hopital de la Tronche
La Tronche, 38700
Département d''Endocrinologie, Diabétologie, Nutrition ; CHU Montpellier ; Hôpital Lapeyronie, Avenue du Doyen Giraud
Montpellier, 34295
Service d'Endocrinologie, Maladies Métaboliques et Nutrition,CHU Nantes,Hôpital Nord Laennec,Bd Jacques-Monod,Saint-Herblain
Nantes, 44093
Service de Diabétologie et Maladies Métaboliques, Assistance Publique des Hôpitaux de Paris ;Hôpital Cochin, 27 rue du Faubourg Saint-Jacques
Paris, 75014
Service d'Endocrinologie, Diabétologie, Maladies de la Nutrition, Hospices Civils de Lyon, Centre hospitalier Lyon-Sud
Pierre-Bénite, 69495
Service de Diabétologie Maladies Métaboliques et Nutrition ; CHU Toulouse, Pôle cardiovasculaire et métabolique, Hôpital Rangueil ; 1, avenue du Professeur Jean Poulhès - TSA 50032
Toulouse, 31059
Service de Diabétologie, Maladies Métaboliques, Nutrition ; CHU Nancy ; Technopôle Nancy-Brabois ; Rue du Morvan,
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes : A Randomized Double-blind Placebo-controlled Trial
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
Read more
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
- Being tested
- Dulaglutide, Placebo
- Keywords
- type 1 diabetes, insulin microsecretion, dulaglutide, randomized, double-blind placebo-controlled trial
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DulaglutideDrug
Dulaglutide 1.5mg : One injection per week during 24 weeks
PlaceboDrug
Placebo: one injection per week during 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dulaglutide | Experimental | Experimental group receiving 1.5 mg Dulaglutide subcutaneously weekly in addition to their usual insulin regimen during 24 weeks Receives: Drug: Dulaglutide |
| placebo | Placebo comparator | Control group receiving placebo subcutaneously weekly in addition to their usual insulin regimen during 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c level
Blood level
Measured: after 24 weeks of treatment
Secondary outcomes (14)
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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: : before and after 24weeks of treatment
: Body weight
Measured: 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
Measured: 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
Measured: 20 months
Number of adverse events
Evaluation and comparison the number of adverse events with Dulaglutide vs placebo during the study
Measured: 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
Measured: : before and after 24wks of treatment
insulin doses : basal/ prandial ratio
the insulin basal/ prandial ratio
Measured: 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
Measured: 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
Measured: 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 .
Measured: the run-in period (1 month) and after 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start31 Jan 2019
- Primary completion3 Feb 2021
- Study completion3 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Subjects With Type1Diabetes and Insulin MicrosecretionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles THIVOLET, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668470
- Sponsor's protocol ID
- 69HCL18_0047
- Acronym
- DIAMOND GLP1
- Status last verified
- Jul 2021
- First submitted
- 11 Sep 2018
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes : A Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03668470
- Acronym / sponsor ID
- DIAMOND GLP1 / 69HCL18_0047
- Keywords
- type 1 diabetes, insulin microsecretion, dulaglutide, randomized, double-blind placebo-controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 3 Feb 2021 (actual)
- Study completion
- 3 Feb 2021 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentric, investigator-initiated, randomized, double-blinded, therapeutic clinical trial, placebo-controlled, two arm parallel group intervention trial during 24 weeks, phase II.
| Arm | Type | Receives |
|---|---|---|
| Dulaglutide | Experimental | Drug: DulaglutideExperimental group receiving 1.5 mg Dulaglutide subcutaneously weekly in addition to their usual insulin regimen during 24 weeks |
| placebo | Placebo comparator | Drug: PlaceboControl group receiving placebo subcutaneously weekly in addition to their usual insulin regimen during 24 weeks |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DulaglutideDulaglutide 1.5mg : One injection per week during 24 weeks | Drug | Dulaglutide |
| PlaceboPlacebo: one injection per week during 24 weeks | Drug | placebo |
Primary outcome
HbA1c level
Time frame: after 24 weeks of treatment
Blood level
14 secondary outcomes
AUC us C-peptide following a MMT
Time frame: before and after 24 weeks of treatment
Glucagon levels fasting and following a MMT
Time frame: before and after 24 weeks of treatment
AUC us C-peptide over AUC blood glucose levels following a MMT
Time frame: 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
Time frame: the run-in period (1 month) and after 24 weeks of treatment
Daily insulin doses and basal/ prandial ratio
Time frame: : before and after 24weeks of treatment
: Body weight
Time frame: before and after 24weeks of treatment
% carbohydrates
Time frame: the run-in period (1 month) and after 24 weeks of treatment
Number of symptomatic hypoglycemic episodes
Time frame: 20 months
Number of adverse events
Time frame: 20 months
Autoantibodies to GAD65
Time frame: : before and after 24wks of treatment
insulin doses : basal/ prandial ratio
Time frame: before and after 24weeks of treatment
Autoantibodies to IA-2
Time frame: before and after 24wks of treatment
Autoantibodies to ZnT8
Time frame: before and after 24wks of treatment
coefficients of variation (CV)
Time frame: the run-in period (1 month) and after 24 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles THIVOLET principal investigator
Hospices Civils de Lyon
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dulaglutide in people with Adult Subjects With Type1Diabetes and Insulin Microsecretion, run by Hospices Civils de Lyon at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c level (time frame: after 24 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.