Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial)

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

The purpose of this pilot trial is to determine whether an intensive treatment with insulin glargine, metformin, acarbose and lifestyle can normalize blood glucose levels in patients with recently diagnosed type 2 diabetes mellitus when compared to standard diabetes care.

It had three arms (groups): Group 1 (short) (experimental), Group 2 (long) (experimental) and Standard care (other).

The registry classes the interventions as behavioral, drug and other.

Who Took Part

Enrollment: 83 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 3 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).

The full record lists 9 inclusion and 23 exclusion criteria; among the exclusions: current use of insulin therapy; history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance; 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.

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

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

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

It started in 2011-01 with completion listed for 2015-02.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Normoglycemia on Therapy (time frame: (1) 8 weeks and (2) 16 weeks).

It also tracked 7 secondary outcomes, for example Percentage of Participants With Normal Fasting Plasma Glucose, Change in Fasting Plasma Glucose From Baseline, HbA1C, Change in Weight From Baseline, Number of Participants With Symptomatic Hypoglycemic Episodes and Number of Participants With Severe Hypoglycemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 83 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.