Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide

What Was Tested

The trial (phase 3) is built around Liraglutide.

A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.

It had two arms (groups): Group 1 (experimental) and Group 2 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 136 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Diagnosis of type 2 diabetes ≥ 3 months. Stable body weight ≥ 3 months. Body mass index (BMI) ≥25 to ≤45 kg per meter squared. Calcitonin \<50 ng/L (50 pg/mL) at the Screening Visit.

The full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: history of type 1 diabetes; recent use or of anti-diabetic medications other than liraglutide or metformin; history or evidence of acute or chronic pancreatitis.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

It started in 2015-12 with completion listed for 2017-10.

It ran at 36 sites in United States (36).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting (time frame: From Randomization to 34 weeks).

It also tracked 4 secondary outcomes, for example Number (percentage) and severity of all treatment-emergent adverse events, Incidence of hypoglycemia, Change in percentage of glycosylated hemoglobin (HbA1c) in the blood and Change in body weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 136 people.

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

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