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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00111800 | A New Oral Treatment For Type II Diabetes Mellitus | PHASE2 | COMPLETED | 375 | — | — | Apr 28, 2005 | Jul 21, 2006 | Mar 21, 2018 | 109 | United States, Canada +8 |
HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. Analysis of covariance (ANCOVA) model for analysis was used with the terms for gender, prior therapy (diet \& exercise/monotherapy), treatment, region and Baseline measurement (continuous covariate). Last observation carried forward (LOCF) dataset defined as carrying forward of the last valid observation recorded on-treatment (scheduled or unscheduled) for participants who withdrew from the study to all remaining main phase visits was used. Adjusted mean is reported as least square (LS) mean.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received oral dose of matching placebo capsule to denagliptin (DEN) once daily in the morning, 30 minutes (min) prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 milligram (mg) once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants. |
| DEN 2.5 mg | EXPERIMENTAL | Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants. |
| DEN 7.5 mg | EXPERIMENTAL | Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants. |
| DEN 15 mg | EXPERIMENTAL | Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants. |
| DEN 30 mg | EXPERIMENTAL | Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants. |
| DEN 45 mg | EXPERIMENTAL | Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. |
| DEN 2.5 mg | DRUG | DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. |
| DEN 7.5 mg | DRUG | DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. |
| DEN 15 mg | DRUG | DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. |
| DEN 30 mg | DRUG | DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. |
| DEN 45 mg | DRUG | DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. |
Inclusion criteria: * Women must not be pregnant and must not be breastfeeding. * Have Type II diabetes. * Not taking any medicine for diabetes, or taking one oral medicine for their diabetes. Exclusion criteria: * Have any underlying or significant active disease that would prevent the subject f...