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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01152242 | Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin (0000-168) | PHASE1 | COMPLETED | 36 | — | — | Aug 1, 2010 | May 1, 2012 | Jul 23, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| Part 1 | ACTIVE_COMPARATOR | Part I of the trial |
| Part 2 | ACTIVE_COMPARATOR | Part II of the trial |
| Name | Type | Description |
|---|---|---|
| Isoglycemic Clamp | DRUG | Isoglycemic Clamp, a procedure that includes IV infusion of short-acting Insulin (Part I) and glucose (Part I and 2) |
| Comparator: insulin glargine | DRUG | Insulin glargine at 0.4 U/kg |
Inclusion Criteria: Part 1: * Patient is a male between 18 to 45 years of age (inclusive) at the prestudy (screening) visit * Patient has a clinical diagnosis of type 1 diabetes * Patient must have been treated with insulin since diagnosis and be on a stable dose of insulin * Patient has a Body Ma...