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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01811485 | Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy | PHASE3 | COMPLETED | 171 | — | — | May 1, 2013 | Feb 1, 2014 | Feb 23, 2015 | 30 | Japan |
HbA1c was performed on a blood sample obtained and measured by High performance liquid chromatography (HPLC). HPCL was performed at a central laboratory.
| Arm | Type | Description |
|---|---|---|
| LMF237 50/250 mg | EXPERIMENTAL | Patients took LMF237 50/250 mg twice daily for 14 weeks |
| LMF237 50/500 mg | EXPERIMENTAL | Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks |
| Placebo | PLACEBO_COMPARATOR | Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks |
| Name | Type | Description |
|---|---|---|
| LMF237 50/250 mg | DRUG | Corresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily |
| LMF237 50/500 mg | DRUG | Corresponds to vildagliptin 50 mg twice daily and metformin 500 mg twice daily |
| Placebo | DRUG | Matching placebo of LMF237 (contained vildagliptin 50 mg as active ingredient) twice daily |
Inclusion Criteria: * Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy * HbA1c in the range of 7.0-10.0% * Body mass index in the range of 20-35 kg/m\^2 Exclusion Criteria: * Type 1 diabetes, monogenic diabetes, diabetes resulting from pancr...