Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type II Diabetes

What Was Tested

This registered phase 4 trial tested Insulin (regular human).

It had two arms (groups): Vildagliptin (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 191 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: Informed consent read and signed before any protocol procedure. Free will to sign the informed consent. Male and female between 18 and 80 years. If female, patient must be non-fertile or of childbearing potential using a medically approved birth control method. Type 2 diabetes mellitus. Body mass index (BMI) between 20 to 35 kg/m2.

The full record lists 9 inclusion and 11 exclusion criteria; among the exclusions: pregnant or lactating female or without birth control method if of childbearing potential; type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., cushing's syndrome; acute cardiovascular complications or metabolic complications within the past 4 months.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2013-05 with completion listed for 2015-07.

It ran at 13 sites in Mexico (13).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of patients with hyperglycemic events evaluated with CGM (time frame: At 13 weeks).

It also tracked 14 secondary outcomes, for example Number of hypoglycemia and/or hyperglycemia measured by CGM, Average of insulin units per day administered during the study, Changes from the baseline in Lipid Profile, Change from baseline in Body weight, Change from baseline in Blood pressure (BP), and Change from baseline in Fasting plasma glucose (FPG),.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 191 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.