Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Insulin Aspart.

It had two arms (groups): Glargine based therapy (experimental) and Premixed insulin (active comparator).

Once daily glargine plus prandial oral anti-hyperglycemic drugs.

Twice daily premixed insulin.

The registry classes the interventions as drug.

More on the Plan

The duration of study is approximately 21 months.

Each patient will be followed for approximately 27 weeks from screening visit to end-of-study.

Who Took Part

The registry lists 384 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Patients with age between 18 and 70 years. Fasting C peptide \>1 ng/mL. Type 2 diabetes (T2DM) patients with diabetes diagnosis between 2 and 10 years (World Health Organization 1999 T2DM diagnose criteria). Body mass index ≥21 kg/m2, and \<40 kg/m2.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: more than 7 consecutive days of insulin treatment within the 12 months except for acute disease or surgery; diabetes other than t2dm (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake); history of hypoglycemia unawareness or recurrent hypoglycemia or severe hypoglycemia within the past 12 months.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2018-01-20 with completion listed for 2020-06-29.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in hemoglobin A1c (HbA1c) (time frame: Baseline to Week 24).

It also tracked 13 secondary outcomes, for example Hypoglycemic events, Change in FPG, Change in body weight, Daily BG variation at week 24, European quality of life - 5 dimensions (EQ-5D) and Subgroup analysis.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 384 people.

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 and the Insulin Aspart compound page, all human trials.