Insulin Secretion in Diabetes Before and After Glycemic Control

What Was Tested

The trial (not phased) is built around Insulin Glargine.

The objective of this project is to understand defects in insulin secretion that contribute to abnormal glucose metabolism in patients with diabetes.

In particular the effects of signals released from the intestine to stimulate insulin secretion will be tested.

Patients with type 2 diabetes will have insulin secretion in response to glucose and intestinal factors before and after insulin treatment to lower their blood glucose.

It had 1 arm (groups): Arm 1 (experimental).

The registry classes the interventions as drug.

More on the Plan

Specifically, this project will seek to determine the mechanism(s) by which the incretin effect is impaired in diabetic patients.

There are several studies indicating that this response is severely impaired in patients with type 2 diabetes.

The mechanism(s) by which this occurs has not been explained.

The problem with the current state of knowledge in this area is that previous work has involved small numbers of diabetic subjects, and did not directly test mechanisms by which the incretin effect is altered in diabetes.

Who Took Part

17 actual participants took part.

It was open to people of any sex aged from 30 years up to 65 years.

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

Examples of who could join: Male/female 30-65 yrs old,. Free of active medical disease,. No history of diabetes. Treated with metformin, a sulfonylurea, or combination,. Stable body wt with BMI 28-40.

The full record lists 11 inclusion and 3 exclusion criteria; among the exclusions: aim 1: for both groups: no history of: pancreatitis, cardiac, gastrointestinal, renal or liver disease; aim 2: same as above; aim 3: same as above, plus a diagnosis of incipient diabetic nephropathy severe nonproliferative, or proliferative retinopathy.

How the Study Was Run

The set-up was single-group and open-label.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2008-04 with completion listed for 2011-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a not phased trial of Insulin Glargine in 17 people.

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

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, all human trials.