Evaluate Quality of Life in Type 2 Diabetes, Before and After Change to Insuline Glargine

What Was Tested

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

Primary objective: To assess quality of Life (QoL) changes and treatment satisfaction in a real life situation in patients with Type 2 diabetes inadequately controlled on a combination of oral antidiabetic drugs (OAD) plus Neutral Protamine Hagedrone (NHP) insulin treatment that are switched to insulin glargine.

It had 1 arm (groups): 1 (experimental).

Insulin glargine.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 26 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

The full record lists 0 inclusion and 10 exclusion criteria; among the exclusions: patients with type 2diabetes inadequately controlled on a combination of oad + nph insulin for more than three months; ability to perform qol assessment; body mass indes: women \<30 and men \<32.

How the Study Was Run

Design: non-randomized, single-group and open-label.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2005-10 with completion listed for 2008-03.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The fear of hypoglycaemia scale (HFS) (time frame: before the switch to insulin glargine and at 3 and 9 months of follow up). 12 - Item Well-Being Questionnaaire (WBQ12) (time frame: before the switch to insulin glargine and at 3 and 9 months of follow up). Glycaemic controll will be asessed by HbA1c values (time frame: week 12 and week 40).

It also tracked 1 secondary outcome, for example Incidence of symptomatic hypoglycemia and severe hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Glargine in 26 people.

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

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

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