Comparing Efficacy and Safety of CinnaGen-liraglutide Versus Victoza® in Patients With Type II Diabetes

What Was Tested

The trial (phase 3) is built around Liraglutide.

Patients with Type II diabetes treated with two oral glucose-lowering agents for ≥ 3 months, aged between 30 to 65 years, HbA1c equal or greater than 7.5 and lower than 10, and BMI between 25 to 45 were included in this study.

It had two arms (groups): one (experimental) and Victoza® (active comparator).

The registry classes the interventions as drug.

More on the Plan

Patients with Type II diabetes treated with two oral glucose-lowering agents for ≥ 3 months, aged between 30 to 65 years, HbA1c equal or greater than 7.5 and lower than 10, and BMI between 25 to 45 will be included in this study.

Physical examinations and vital signs will be evaluated for patients at baseline, and at weeks 4, 8, 12 and 26 visits.

Laboratory parameters will be assessed at baseline, week 12 and 26.

The incidence of adverse events will be evaluated based on patients' reports, vital signs, physical examinations, and laboratory tests.

Who Took Part

300 planned participants were the target.

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

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

Examples of who could join: 30-65 years of age. 7.5 ≤ HbA1c \< 10. Body mass index (BMI) of 25-45 kg / m2.

The full record lists 4 inclusion and 17 exclusion criteria; among the exclusions: lack of consent for being in the trial and not complying with 26-weeks follow-up period;; hypersensitivity to liraglutide or any component of the formulation (excipients include disodium phosphate dehydrate, propylene glycol, phenol, water for injection); insulin treatment during the previous 3 months (except short-term treatment for intercurrent illness).

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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

The Liraglutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2019-06-20 with completion listed for 2019-12-01.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (time frame: 26 weeks).

It also tracked 11 secondary outcomes, for example Body weight, Fasting blood sugar, Postprandial glucose, Systolic blood pressure, Diastolic blood pressure and Lipid profiles.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 300 people.

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

More context: the Liraglutide compound page, all human trials.