Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes

What Was Tested

In this phase 2 trial, researchers set out to test Exenatide.

These cells produce insulin, which regulates blood sugar.

It had four arms (groups): Group 1 (experimental), Group 2 (experimental), Group 3 (experimental) and Group 4 (experimental).

Group 1 will receive immunosuppression and AC2993; then immunosuppression only.

Group 2 will receive AC2993 only; then neither immunosuppression nor AC2993.

Group 3 will receive immunosuppression and AC2993; then immunosuppression and AC2993.

The registry classes the interventions as drug.

More on the Plan

Previous studies indicate that some patients retain the capacity for limited endogenous insulin production.

Thus, the researchers plan to enroll adults with long-standing T1DM who have some C-peptide secretion indicating residual beta cell mass.

The latter will be targeted by AC2993.

Due to the possibility of stimulating the underlying autoimmune process of T1DM, especially if islet regeneration occurs, the researchers will subject half of the enrollees to immunosuppression.

Who Took Part

The registry lists 47 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Current or past anti-islet antibodies (anti-insulin before initiation of insulin therapy, anti-islet cell (ICA), anti-tyrosine phosphatase IA-2, and/or anti-glutamic acid decarboxylase (GAD65) antibodies). BMI greater than or equal to 20 kg/m(2) and less than or equal to 30 kg/m(2).

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: leukopenia (wbc count less than 3.4 k/mm(3)); thrombocytopenia (platelet count less than 162 k/mm(3)).

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Exenatide and the comparison at some point, usually with a gap in between.

Being open-label, the Exenatide study did not mask who received what.

It started in 2003-07 with completion listed for 2008-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in basal C-peptide level (time frame: baseline and 6 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 47 people.

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

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