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DIAMOND GLP1

CompletedPhase 2

Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes

Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes : A Randomized Double-blind Placebo-controlled Trial

Lead sponsor

Hospices Civils de Lyon

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 1 diabetes

Key I/E criteria

•BMI ≤30•HbA1c 7-10%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03668470

Org study ID69HCL18_0047

Timeline

Milestones

Study first posted2018-09-12actual

Study start2019-01-31actual

Primary completion2021-02-03actual

Study completion2021-02-03actual

Last update posted2021-07-08actual

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age20 Years

Maximum age60 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

: Body weight

Time frame:before and after 24weeks of treatment

change from baseline, improvement

Glycemic / diabetes

7 endpoints

Primary/protocol endpoint

HbA1c level

Time frame:after 24 weeks of treatment

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

AUC us C-peptide following a MMT

Time frame:before and after 24 weeks of treatment

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

AUC us C-peptide over AUC blood glucose levels following a MMT

Time frame:before and after 24 weeks of treatment

ratio, improvement

Secondary/protocol endpoint

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

CGM time-in-range

percent change from baseline, improvement

Secondary/protocol endpoint

Daily insulin doses and basal/ prandial ratio

Time frame:: before and after 24weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint/low confidence

insulin doses : basal/ prandial ratio

Time frame:before and after 24weeks of treatment

ratio, descriptive

Secondary/protocol endpoint

coefficients of variation (CV)

Time frame:the run-in period (1 month) and after 24 weeks of treatment

descriptive

Safety / tolerability / PK

5 endpoints

Secondary/protocol endpoint

Number of symptomatic hypoglycemic episodes

Time frame:20 months

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of adverse events

Time frame:20 months

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Autoantibodies to GAD65

Time frame:: before and after 24wks of treatment

change from baseline, descriptive

Secondary/protocol endpoint

Autoantibodies to IA-2

Time frame:before and after 24wks of treatment

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Autoantibodies to ZnT8

Time frame:before and after 24wks of treatment

change from baseline, descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Glucagon levels fasting and following a MMT

Time frame:before and after 24 weeks of treatment

descriptive

Secondary/protocol endpoint/low confidence

% carbohydrates

Time frame:the run-in period (1 month) and after 24 weeks of treatment

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.