Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03130426 | Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi | PHASE3 | COMPLETED | 161 | — | — | Jun 27, 2017 | Sep 30, 2020 | Nov 13, 2020 | 8 | Canada |
| Arm | Type | Description |
|---|---|---|
| Intervention | EXPERIMENTAL | Drug: iGlarLixi - sc injection; Drug: metformin - oral administration; Drug: insulin glargine - sc injection; Behavioral: lifestyle therapy, diet and exercise |
| Standard Care | NO_INTERVENTION | Standard glycemic care as informed by the current clinical practice guidelines |
| Name | Type | Description |
|---|---|---|
| iGlarLixi | DRUG | Dose is titrated to achieve fasting normoglycemia |
| Insulin Glargine | DRUG | In those who need additional insulin or who cannot tolerate iGlarLixi, insulin glargine will be used. Dose is titrated to achieve fasting normoglycemia. |
| Metformin | DRUG | Dose is titrated to 2000 mg daily or maximal tolerated dose |
| Lifestyle therapy | BEHAVIORAL | Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving |
Inclusion Criteria: 1. men and women aged 30-80 years; 2. type 2 diabetes mellitus within 5 years of diagnosis; 3. stable diabetes drug regimen in the 10 weeks before randomization; 4. HbA1c 6.5-9.5% on no glucose lowering drugs, or \</= 8.5% on 1 glucose-lowering drug, or \</= 8.0% on 2 glucose lo...