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This is an open label phase 1b trial of QX1206 in patients with T2DM and with NAFLD. Laboratory tests and other measurements will be assessed prior to the first dose of study treatment and throughout the study to determine the recommended phase 2 dose. In addition, the preliminary effects of QX1206 on antidiabetic activity and other metabolic parameters will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QX1206 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QX1206 | Drug | QX1206 will be administered orally before bedtime |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 Dose (RP2D) | Baseline Day 1 up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) | Change in HbA1c percentage from baseline with QX1206 | 12 Weeks |
| Fasting plasma glucose (FPG) | Change in FPG mg/dL from baseline with QX1206 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 1Globe Health Institute | Contact | 617-649-1157 | T2DM-QX1206-1_Study@1globe-usa.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Keates, PhD | 1Globe Health Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centricity Research Toronto LMC. | Recruiting | Toronto | Canada |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 12 Weeks |
| Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Change in the HOMA-IR from baseline with QX1206 | 12 Weeks |
| Fasting insulin | Change in fasting insulin pmol/L from baseline with QX1206 | 12 Weeks |
| D004700 | Endocrine System Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |