Aggressive Versus Conservative Blood Glucose Control in Hospitalized Type 2 Diabetic Patients Using Detemir and Aspart Insulin

What Was Tested

The trial (phase 4) is built around Insulin Aspart and Insulin Detemir.

It had two arms (groups): Conservative Blood Glucose Control (active comparator) and Aggressive Blood Glucose Control (active comparator).

The registry classes the interventions as drug.

More on the Plan

Patient Population: The population for this study includes men and women with type 2 diabetes admitted to the general medicine wards of Parkland Memorial Hospital.

Patients admitted to Parkland Hospital with type 2 diabetes will be recruited to the study within 24 hours of admission.

Gravid patients, patients in DKA, or HHS will be excluded.

All patients will be evaluated for inclusion and exclusion criteria.

Who Took Part

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Existing diagnosis of type 2 diabetes. Admitted to a non-telemetry, non-ICU medicine inpatient bed. Willing and able to give informed consent. HgbA1c of any value will be accepted.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: type 1 diabetes; admitted to a telemetry, icu, or non-medicine inpatient bed (e.g., surgery, neurosurgery, obstetrics/gynecology, psychiatry); diabetic ketoacidosis (arterial ph \<7.24, serum bicarbonate \<15, positive serum ketones, anion gap \>12).

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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

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

Only one side, usually the participants, was kept unaware of whether Insulin Aspart was given.

Those kept unaware of assignments: participant.

It started in 2009-05 with completion listed for 2010-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Length of Hospitalization Stay (time frame: 18 months).

It also tracked 9 secondary outcomes, for example Cost of Hospitalization, All-Cause Mortality, Frequency of Hypoglycemic Episodes, Rate of Transfer to Telemetry Unity, Rate of Nosocomial Infections and Rate of Surgical Procedures.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Aspart compound page and the Insulin Detemir compound page, all human trials.