A Study of Postprandial Hyperglycemia in Participants With Type 2 Diabetes

What Was Tested

The trial (phase 4) is built around Insulin Lispro.

This Study is looking at whether high blood glucose levels after a meal affect arterial stiffness more or less than low blood glucose levels, and whether certain cardiovascular markers influence the outcome of this.

It had three arms (groups): T2DM, albuminuria but normal kidney function (experimental), Healthy participants (no intervention) and T2DM, normal urinary albumin excretion rate (UAER) (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 72 actual participants took part.

It was open to men only aged from 45 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Are diagnosed with T2DM (according to the American Diabetes Association classification \[American Diabetes Association 2006\]) and on insulin therapy for at least 6 months. Have not smoked in the last 12 hours prior to the study visit. Participants have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol. Each participant must understand the nature of the study and must sign an informed consent document (ICD). Healthy participants 45 to 70 years of age, matched for age and BMI, who have not smoked in the last 12 hours prior to the study.

The full record lists 9 inclusion and 5 exclusion criteria; among the exclusions: have arrhythmias; have an acute infection; are unwilling or unable to comply with the use of a data collection device to directly record data from the participant.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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

Each person switched between Insulin Lispro and the comparison at some point, usually with a gap in between.

Being open-label, the Insulin Lispro study did not mask who received what.

It started in 2010-10 with completion listed for 2013-02.

It ran at 1 site in Finland.

What Was Measured

The main thing measured (primary outcome): Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast (time frame: 30 mins (pre-breakfast)). Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast (time frame: 60 mins (post-breakfast)). Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast (time frame: 120 mins (post-breakfast)).

It also tracked 5 secondary outcomes, for example Change in Pulse Wave Amplitude (PWA), Change in Peripheral Artery Tonometry (PAT), Change in QT Interval on Electrocardiogram (ECG), Change in Blood Glucose (BG) and Change in Postprandial Pulse Wave Velocity (PWV).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Lispro in 72 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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