Trials / Completed
CompletedNCT02561130
Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Forxiga
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 154 (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 Forxiga, metformin, basal insulin glargine 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 152 patients with recently-diagnosed T2DM. Participants will be randomized to 2 treatment groups: (a) a 12-week course of treatment with Forxiga, metformin, insulin glargine 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | insulin glargine | Dose is titrated to achieve fasting normoglycemia |
| DRUG | metformin | Dose is titrated to 1 g bid or maximal tolerated dose |
| DRUG | Forxiga | Dose is titrated to 10 mg po 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
- 2015-12-01
- Primary completion
- 2017-07-01
- Completion
- 2018-12-31
- First posted
- 2015-09-25
- Last updated
- 2020-11-24
- Results posted
- 2020-11-24
Locations
7 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT02561130. Inclusion in this directory is not an endorsement.