Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Sitagliptin (REMIT-Sita)

What Was Tested

In this phase 3 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: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy.

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 100 patients with recently-diagnosed T2DM.

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

Who Took Part

Enrollment: 102 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 5 years prior to patient enrollment;. Body mass index ≥ 23 kg/m2;. A negative pregnancy test and an agreement to use a reliable method of birth control for the duration of the trial in all females with childbearing potential;. 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 12 exclusion criteria; among the exclusions: current use of insulin;; history of hypoglycemia unawareness; history of severe hypoglycemia requiring assistance within the last 5 years;; renal dysfunction as evidenced by serum creatinine (cr) ≥ 124 μmol/l;.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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 2016-07-09 with completion listed for 2018-09-01.

It ran at 6 sites in Canada (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With Hyperglycemia Relapse in the Experimental Group Compared to the Control Group (time frame: 64 weeks of follow-up). Number of Participants With Severe Hypoglycemic Episodes (time frame: 64 weeks of follow-up).

It also tracked 4 secondary outcomes, for example Number of Participants Achieving Drug-free Diabetes Remission, Number of Participants With Drug-free Normal Glucose Tolerance, Percent Change in Weight and Change in Waist Circumference.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 102 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.