Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes

What Was Tested

This registered phase 2 trial tested Dulaglutide.

Some patients with type 1 diabetes (T1D) can still have some remaining insulin-positive cells in the pancreas and secrete little amounts of insulin.

It had two arms (groups): Dulaglutide (experimental) and placebo (placebo comparator).

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 45 actual participants took part.

It was open to people of any sex aged from 20 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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.

The full record lists 10 inclusion and 14 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.

The Dulaglutide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Dulaglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-01-31 with completion listed for 2021-02-03.

It ran at 7 sites in France (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: HbA1c level (time frame: after 24 weeks of treatment).

It also tracked 14 secondary outcomes, for example AUC us C-peptide following a MMT, Glucagon levels fasting and following a MMT, AUC us C-peptide over AUC blood glucose levels following a MMT, : Body weight, % carbohydrates and Number of symptomatic hypoglycemic episodes.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dulaglutide in 45 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Dulaglutide compound page, all human trials.