NCT03130426

Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether in patients with early type 2 diabetes, a short-term intensive metabolic intervention comprising iGlarLixi, metformin, and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission.

Detailed description

This is a multicentre, open-label, randomized controlled trial in 160 patients with recently-diagnosed T2DM. Participants will be randomized to 2 treatment groups: (a) a 12-week course of treatment with iGlarLixi, metformin and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 64 weeks (1 year and 3 months). In all participants with HbA1C\<7.3% at the 12 week visit, glucose-lowering medications will be discontinued and participants will be encouraged to continue with lifestyle modifications and regular glucose monitoring. Participants with HbA1C ≥ 7.3% at this visit or who experience hyperglycemia relapse after stopping drugs will receive standard glycemic management as informed by the current Canadian Diabetes Association clinical practice guidelines.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	iGlarLixi	Dose is titrated to achieve fasting normoglycemia
DRUG	Insulin Glargine	In those who need additional insulin or who cannot tolerate iGlarLixi, insulin glargine will be used. Dose is titrated to achieve fasting normoglycemia.
DRUG	Metformin	Dose is titrated to 2000 mg daily or maximal tolerated dose
BEHAVIORAL	Lifestyle therapy	Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving

Timeline

• Start date: 2017-06-27
• Primary completion: 2019-06-30
• Completion: 2020-09-30
• First posted: 2017-04-26
• Last updated: 2020-11-13

Locations

8 sites across 1 country: Canada