Gastric Modulator (TANTALUS® System) Versus Insulin Treatment in Obese Type 2 Diabetic Patients - a Randomized Control Trial

What Was Tested

In this phase 3 trial, researchers set out to test Insulin (regular human).

This study aims to analyze the pre- and post-operative clinical, hormonal and biochemical changes in moderately obese type 2 diabetic patients who are sub-optimally controlled on at least 2 anti-diabetic agents.

Study participants will either receive implantation of the gastric contraction modulator or conventional treatment with insulin therapy.

It had two arms (groups): Tantalus (experimental) and Control (active comparator).

Insulin treatment will be prescribed, in accordance with the common medical practice at the institute. Dosages will be recorded on a daily basis.

The registry classes the interventions as device and drug.

Who Took Part

The registry lists 24 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Able to provide written informed consent. Adult patients aged between 18 and 60 years (inclusive). Type 2 diabetes mellitus with disease duration of greater than 2 and less than 10 years.

The full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: on anti-obesity drugs; on insulin treatment at the time of the recruitment; on glitazone or incretins (dipeptidyl peptidase-4 inhibitor or glucagons-like peptide-1) treatment.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2009-10 with completion listed for 2011-07.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: changes in body weight before and after interventions at 6 and 12 months (time frame: 6 months and 1 year). changes in HbA1c before and after interventions (time frame: 6 and 12 months). frequency of hypoglycaemia (time frame: 6 month and 1 year).

It also tracked 7 secondary outcomes, for example waist circumferences, insulin secretory responses (as measured by the standard meal test), Hormonal profiles (including gut hormones), resting energy expenditure as monitored by indirect calorimetry (MedGem), radiological assessment (ultrasound scan and densitometry to measure mesenteric and total body fat respectively) and differences in insulin requirement.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 24 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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