Skip to main content
OpenTrials
Completed

NCT Number: NCT03668470

Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adult Subjects With Type1Diabetes and Insulin Microsecretion Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Service d'Endocrinologie, Maladies Métaboliques et Nutrition, CHU Grenoble, Hopital de la Tronche, La Tronche, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dulaglutide

Drug

Dulaglutide 1.5mg : One injection per week during 24 weeks

Placebo

Drug

Placebo: one injection per week during 24 weeks

Primary outcomes

  1. HbA1c level

    Time frame: after 24 weeks of treatment

    Blood level

Secondary outcomes

  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 .

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: DIAMOND GLP1

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 12, 2018
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.