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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01241448 | A Study of LY2409021 in Patients With Type 2 Diabetes | PHASE2 | COMPLETED | 263 | — | — | Jan 1, 2011 | Mar 1, 2012 | Apr 24, 2018 | 40 | United States, Germany +5 |
| NCT00871572 | A Study for Participants With Type 2 Diabetes Mellitus | PHASE2 | COMPLETED | 87 | — | — | Mar 1, 2009 | Feb 1, 2010 | Apr 24, 2018 | 19 | United States, Germany +1 |
| NCT01588366 | The Effects of LY2409021 on the Liver | PHASE1 | COMPLETED | 30 | — | — | Apr 1, 2012 | Sep 1, 2013 | Mar 7, 2019 | 1 | Singapore |
| NCT01460368 | A Study on the Effects of LY2409021 on the Electrical Impulses of the Heart | PHASE1 | COMPLETED | 67 | — | — | Oct 1, 2011 | Mar 1, 2012 | Jan 7, 2019 | 1 | United States |
| NCT01606397 | A Study of Multiple Increasing Doses of LY2409021 in Participants With Type 2 Diabetes | PHASE1 | COMPLETED | 50 | — | — | Mar 1, 2008 | Nov 1, 2008 | May 25, 2012 | 2 | Singapore, United Kingdom |
| NCT01606371 | A First-in-Human Study of LY2409021 in Healthy Participants and Participants With Type 2 Diabetes | PHASE1 | COMPLETED | 32 | — | — | May 1, 2007 | Oct 1, 2007 | May 25, 2012 | 1 | Singapore |
Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was calculated using a mixed-model repeated measures analysis (MMRM) that included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.
Measured by magnetic resonance (MR) scanning.
Measured by MR scanning.
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Least Squares (LS) means were calculated using mixed effects model with fixed effects for treatment, time, period, sequence, and the time-by-treatment interaction, random effects for participant, the participant-by-treatment interaction, and participant-by-time interaction.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. |
| 2.5 mg LY2409021 | EXPERIMENTAL | Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. |
| 10 mg LY2409021 | EXPERIMENTAL | Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. |
| 20 mg LY2409021 | EXPERIMENTAL | Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. |
| LY2409021 10 milligrams (mg) | EXPERIMENTAL | - |
| LY2409021 30 mg | EXPERIMENTAL | - |
| LY2409021 60 mg | EXPERIMENTAL | - |
| 15 mg LY2409021 | EXPERIMENTAL | Part B - 1 capsule of 15 mg LY2409021 orally once a day for 28 days. (Arm added in September, 2012, per protocol amendment.) |
| 60 mg LY2409021 | EXPERIMENTAL | Part A - 4 capsules of 15 mg LY2409021 administered orally once a day for 28 days. |
| Part A: LY2409021 | EXPERIMENTAL | Participants will receive 2 standard meals; one alone without LY2409021, and one along with a single dose of 300 milligrams (mg) LY2409021 administered orally. Participants enrolled in Part A will not be allowed to participate in Part B. |
| Part B: LY2409021 | EXPERIMENTAL | 300 milligrams (mg) LY2409021 administered orally as a single dose on Day 1 of the relevant treatment period. The treatment and washout period was a total of 15 days in length. |
| Part B: Placebo | PLACEBO_COMPARATOR | Administered orally as a single dose on Day 1 of the relevant treatment period. The treatment and washout period was a total of 15 days in length. |
| Part B: Moxifloxacin | ACTIVE_COMPARATOR | 400 milligrams (mg) Moxifloxacin administered orally as a single dose on Day 1 of the relevant treatment period. The treatment and washout period was a total of 15 days in length. |
| 5 mg LY2409021 | EXPERIMENTAL | 5 mg LY2409021 administered orally once daily for 4 weeks |
| 30 mg LY2409021 | EXPERIMENTAL | 30 mg LY2409021 administered orally once daily for 4 weeks |
| 90 mg LY2409021 | EXPERIMENTAL | 90 mg LY2409021 administered orally once daily for 4 weeks |
| Healthy-Placebo | PLACEBO_COMPARATOR | Placebo (capsule) administered once, orally |
| Healthy-2.5 mg LY2409021 | EXPERIMENTAL | 2.5 mg LY2409021 administered once, orally |
| Healthy-10 mg LY2409021 | EXPERIMENTAL | 10 mg LY2409021 administered once, orally |
| Healthy-30 mg LY2409021 | EXPERIMENTAL | 30 mg LY2409021 administered once, orally |
| Healthy-100 mg LY2409021 | EXPERIMENTAL | 100 mg LY2409021 administered once, orally |
| Healthy-250 mg LY2409021 | EXPERIMENTAL | 250 mg LY2409021 administered once, orally |
| Healthy-500 mg LY2409021 | EXPERIMENTAL | 500 mg LY2409021 administered once, orally |
| Diabetic-Placebo | PLACEBO_COMPARATOR | Placebo (capsule) administered once, orally |
| Diabetic-75 mg LY2409021 | EXPERIMENTAL | 75 mg LY2409021 administered once, orally |
| Diabetic-200 mg LY2409021 | EXPERIMENTAL | 200 mg LY2409021 administered once, orally |
| Diabetic-500 mg LY2409021 | EXPERIMENTAL | 500 mg LY2409021 administered once, orally |
| Name | Type | Description |
|---|---|---|
| LY2409021 | DRUG | Administered Orally |
| Placebo | DRUG | Administered Orally |
| Moxifloxacin | DRUG | Administered orally |
Inclusion Criteria: * Have a diagnosis of Type 2 diabetes mellitus according to the World Health Organization (WHO) diagnostic criteria * Are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. * Are male patien...