Effects of Tirzepatide and Insulin Glargine on Glucolipid Metabolism and Brain Function in Patients With Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Tirzepatide and Insulin Glargine.

The effects of Tirzepatide and Insulin Glargine on glucose and lipid metabolism and inflammation in patients with type 2 diabetes mellitus.

Effects of Tirzepatide on the occurrence and development of cognitive impairment in diabetic patients and its associated pattern of changes in brain neural network characteristics.

It had two arms (groups): Tirzepatide (experimental) and Insulin Glargine (active comparator).

The registry classes the interventions as drug.

More on the Plan

The aim of the study is to investigate the effects of Tirzepatide and Insulin Glargine on glucose and lipid metabolism and inflammation in patients with type 2 diabetes mellitus.

Meanwhile, this study will evaluate the effects of Tirzepatide on the development of cognitive impairment and its associated pattern of changes in neural network characteristics in diabetic patients.

Who Took Part

150 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Type 2 diabetes was diagnosed according to World Health Organization(WHO) classification or other locally applicable diagnostic criteria. No insulin treatment (except for gestational diabetes or short-term use in acute Settings \[duration ≤14 days\]). Body mass index (BMI) ≥ 23 kg/m2.

The full record lists 5 inclusion and 18 exclusion criteria; among the exclusions: type 1 diabetes mellitus (t1dm); had chronic or acute pancreatitis at any time prior to visit 1; A history of proliferative diabetic retinopathy or diabetic macular degeneration or non-proliferative diabetic retinopathy requiring acute treatment.

How the Study Was Run

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

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

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

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

It started in 2022-03-15 with completion listed for 2023-12-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): blood sugar changes (time frame: 40 weeks). blood lipid changes (time frame: 40 weeks). Brain function (time frame: 40 weeks).

It also tracked 2 secondary outcomes, for example Body composition analysis and Inflammation factors, including adiponectin,leptin,IL-1,IL-6,IL-18,TNF-α,ghrelin,asprosin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Tirzepatide and Insulin Glargine in 150 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page and the Insulin Glargine compound page, all human trials.