GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes

What Was Tested

The trial (early phase 1) is built around GIP (Gastric Inhibitory Polypeptide).

Investigation of GIP effects at fasting and hypoglycemia.

It had three arms (groups): hyperglycemia (experimental), fasting glycemia (experimental) and hypoglycemia (experimental).

The registry classes the interventions as other.

Who Took Part

12 actual participants took part.

It was open to men only aged from 18 years up to 70 years.

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

Examples of who could join: Caucasians 18 years or older with Type 2 diabetes (WHO criteria).

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: liver disease (alat/asat \>2 x upper normal limit); diabetic nephropathy (s-creatinine \>130 µm or albuminuria); proliferative diabetic retinopathy (anamnestic).

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

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

In the crossover set-up each of the participants took both GIP (Gastric Inhibitory Polypeptide) and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received GIP (Gastric Inhibitory Polypeptide).

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2011-05 with completion listed for 2012-07.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: glucagon/insulin(c-peptide) absolute, incremental and area under curve values (time frame: approx. 15 minutes intervals, time 0 to 120 min).

It also tracked 1 secondary outcome, for example plasma gut hormones and nutrients.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of GIP (Gastric Inhibitory Polypeptide) in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the GIP (Gastric Inhibitory Polypeptide) compound page, all human trials.