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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03627715 | Safety and Effectiveness of Propagermanium in Diabetic Kidney Disease Participants Receiving Irbesartan | PHASE2 | COMPLETED | 45 | — | — | Nov 6, 2018 | Aug 18, 2020 | Jul 29, 2022 | 13 | Australia |
Assessed by measuring albumin/creatinine ratio.
| Arm | Type | Description |
|---|---|---|
| Propagermanium then Placebo | EXPERIMENTAL | Propagermanium one capsule orally twice daily for 12 weeks. Compliance will be measured by drug accountability and completion of a participant diary. Participants will receive 12 weeks propagermanium and 12 weeks placebo separated by a 6 week washout period. |
| Placebo then Propagermanium | EXPERIMENTAL | Propagermanium one capsule orally twice daily for 12 weeks. Compliance will be measured by drug accountability and completion of a participant diary. Participants will receive 12 weeks placebo and 12 weeks propagermanium separated by a 6 week washout period. |
| Name | Type | Description |
|---|---|---|
| Propagermanium | DRUG | Immediate release capsule |
| Placebo | DRUG | Placebo capsule |
Inclusion Criteria: 1. Aged 18 to 90 (inclusive) at screening; 2. A diagnosis of type 2 diabetes mellitus; 3. Baseline glycated haemoglobin (HbA1c) ≤ 12%; 4. Fasting plasma glucose \< 21 mmol/L; 5. Must be receiving a stable dose of 300 mg daily of irbesartan (in any marketed formulation) for at le...