Dipeptidyl Peptidase-4 Inhibitor (Sitagliptin) Therapy in the Inpatients With Type 2 Diabetes

What Was Tested

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

It had three arms (groups): Sitagliptin + SSI prn (experimental), Sitagliptin and glargine+ SSI (experimental) and Glargine and Lispro + SSI (active comparator).

Glargine once daily and lispro before meals supplemental insulin lispro as needed for elevated blood glucose using sliding scale insulin (SSI).

The registry classes the interventions as drug.

More on the Plan

Glargine (Lantus®) insulin injection is the most common treatment of diabetes in the hospital.

This study will compare sitagliptin by mouth, insulin (glargine) injection, and the combination of sitagliptin and lantus insulin in controlling blood sugar in hospitalized patients with diabetes.

A total of 90 subjects with type 2 diabetes will be recruited in this study.

Who Took Part

90 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Males or females between the ages of 18 and 80 years admitted to a general medicine and surgery services.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: age \< 18 or \> 80 years; history of tzd treatment (pioglitazone or rosiglitazone) or dpp4 inhibitor (sitagliptin or saxagliptin) during the past 3 months prior to admission; subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.

How the Study Was Run

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

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 2011-08 with completion listed for 2012-05.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean Blood Glucose Levels Among the Three Groups at the Time of Hospitalization to 1st Day After Therapy (time frame: Admission and after 1st day of therapy).

It also tracked 8 secondary outcomes, for example Number of Patients With Hypoglycemic Events Among the Treatment Groups, Number of Patients With Severe Hypoglycemic Episodes Among the 3 Treatment Groups, Mean Length of Stay in Days in the Hospital Among Different Groups and Number of Subjects With Acute Renal Failure Among the Three Randomized Groups During Hospitalization.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 90 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 and the Insulin Lispro compound page, all human trials.