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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00690287 | A Study to Evaluate P-Glucose, Safety and Tolerability After Oral Single Dosing of AZD6370 in Type 2 Diabetic Patients | PHASE1 | COMPLETED | 24 | — | — | Feb 1, 2008 | Jun 1, 2008 | Jan 11, 2012 | 3 | Sweden |
| Arm | Type | Description |
|---|---|---|
| Part A, arm 1 | EXPERIMENTAL | 1\) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo together with food |
| Part A, arm 2 | EXPERIMENTAL | 1\) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo without food |
| Part B, arm1, 2, and 3 | EXPERIMENTAL | 1. AZD6370 dose x mg o.d. 2. dose x/2 mg b.i.d. 3. dose x/4 mg q.i.d. |
| Part B, arm 4 | EXPERIMENTAL | 4\) Placebo |
| Name | Type | Description |
|---|---|---|
| AZD6370 | DRUG | Oral single doses a+b+c, o.d., suspension |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Treated with diet or metformin. Stable glycemic control indicated by no changed treatment within 3 months * Diabetes Mellitus diagnosis \<5 years Exclusion Criteria: * Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two wee...