Study for Beinaglutide Versus Glargine Therapy in Glycemic Variability of Type 2 Diabetes Mellitus

What Was Tested

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

It had two arms (groups): Beinaglutide (experimental) and glargine (active comparator).

1. Beinaglutide for 8 weeks, 2. Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard ).

1. Glargine for 8 weeks, 2. Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard ).

The registry classes the interventions as drug.

Who Took Part

The registry lists 60 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Informed consent obtained before any trial-related activities. Male or female between the age of 18 and 70 years by the time of visit 1. Have been diagnosed as type 2 diabetes for at least half a year. Prestudy combination OAD therapy for at least 1 month(except glinides, DPP-VI inhibitor,insulin,GLP-1 receptor agonists ),.

The full record lists 7 inclusion and 23 exclusion criteria; among the exclusions: females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods ; current diagnosis or history of following:; type 1 diabetes.

How the Study Was Run

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

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

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

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.

It started in 2018-08-07 with completion listed for 2019-12-31.

It ran at 2 sites in China (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The proportion and rate of the fasting blood glucose control (time frame: Baseline and week 16). Changes of blood sugar variation (time frame: Baseline and week 16).

It also tracked 10 secondary outcomes, for example Change percentage of glycosylated hemoglobin, Change of blood glucose, Change of blood pressure, Change of blood lipids, Change of body weight report in kilograms and Change of body mass index report in kg/m^2.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine in 60 people.

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

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