Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Forxiga

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

It had two arms (groups): Intervention (experimental) and Standard Care (no intervention).

Drug: insulin glargine - sc injection; Drug: metformin, oral administration; Drug: forxiga, oral administration; Behavioral: lifestyle therapy, diet and exercise.

Standard glycemic care as informed by the current clinical practice guidelines.

The registry classes the interventions as behavioral and drug.

More on the Plan

This is a multicentre, open-label, randomized controlled trial in 152 patients with recently-diagnosed T2DM.

Participants will be randomized to 2 treatment groups: (a) a 12-week course of treatment with Forxiga, metformin, insulin glargine and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 64 weeks (1 year and 3 months).

Who Took Part

154 actual participants took part.

It was open to people of any sex aged from 30 years up to 80 years.

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

Examples of who could join: Men and women 30-80 years of age inclusive;. Type 2 diabetes mellitus diagnosed by a physician within 8 years prior to patient enrollment;. Body mass index ≥ 23 kg/m2;. Ability and willingness to perform self-monitoring of capillary blood glucose (SMBG);. Ability and willingness to self-inject insulin;.

The full record lists 8 inclusion and 24 exclusion criteria; among the exclusions: current use of insulin therapy;; history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance;; history of lactic acidosis or diabetic ketoacidosis;.

How the Study Was Run

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

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

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

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2015-12 with completion listed for 2017-07.

It ran at 7 sites in Canada (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants Achieving Drug-free Diabetes Remission in the Experimental Group Compared to the Control Group (time frame: 24 weeks after randomization).

It also tracked 8 secondary outcomes, for example Number of Participants Achieving Drug-free Diabetes Remission, Number of Participants Achieving Diabetes Relapse Without Overt Hyperglycemia Off Diabetes Drugs, Glycated Hemoglobin (HbA1C), Number of Participants With Non-severe Symptomatic Hypoglycemic Episodes, Percentage of Weight Loss From Baseline and Change in Waist Circumference From Baseline.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 154 people.

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

More context: the Insulin Glargine compound page, all human trials.