Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin (regular human) and Liraglutide.

It had two arms (groups): Placebo (placebo comparator) and Active drugs (active comparator).

12 weeks of treatment with Insulin, Liraglutide and "Dapagliflozin Placebo".

12 weeks of treatment with Insulin, Liraglutide and "Active Dapagliflozin Drug".

The registry classes the interventions as drug.

More on the Plan

This investigation will be single center, prospective, randomized, double blinded placebo controlled study conducted in type 1 diabetics.

Visit 1: Screening Day (day -21):- Each patient will have completed the following procedures prior to participating in the study. 1.

Baseline lab draws to measure CBC, comprehensive metabolic panel, Hba1c, Fructosamine and lipid profile.

All labs will be drawn in the fasting state in the morning before 10am.

Who Took Part

Enrollment: 26 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Willing to use a continuous glucose monitoring device (CGM) and regularly measuring their blood sugars four times daily. Well versed with carbohydrate counting. Age 18-75 years.

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: type 1 diabetes for less than 12 months; coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; hepatic disease (transaminase \> 3 times normal) or cirrhosis.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2015-08 with completion listed for 2015-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Absolute Change After 12 Weeks From Baseline in Mean HbA1c With Addition of Dapagliflozin Compared to Placebo (time frame: 12 weeks).

It also tracked 6 secondary outcomes, for example Change in 24-hour Urine Glucose Excretion, Change in Total Daily Insulin Requirements, Change in Body Weight, Change in Systolic Blood Pressure Before and After Treatment and Change in Blood Ketone Bodies.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) and Liraglutide in 26 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page and the Liraglutide compound page, all human trials.