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This single-center, randomized, double-blind, placebo-controlled study will evaluate the effect of aleglitazar on insulin sensitivity in patients with type 2 diabetes mellitus who are inadequately controlled on metformin monotherapy. Patients will be randomized to receive either aleglitazar 150 mcg or placebo orally daily for 16 weeks, in addition to their existing dose and regimen of metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aleglitazar | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aleglitazar | Drug | 150 mcg orally daily, 16 weeks |
| |
| metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in whole-body insulin sensitivity as assessed by M-value (Insulin-stimulated glucose disposal rate) | from baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hepatic insulin sensitivity (basal index of hepatic insulin resistance) | from baseline to Week 16 | |
| Change in parameters of beta cell function (first and second phase insulin secretion) | from baseline to Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuss | 41460 | Germany |
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| Drug |
patients will continue on their existing dose and regimen of metformin (but not more than the maximum dose specified in the label) |
|
| placebo | Drug | orally daily, 16 weeks |
|
| Change in HbA1c | from baseline to Week 16 |
| Change in lipid profile | from baseline to Week 16 |
| Change in mean 24h blood pressure | from baseline to Week 16 |
| Change in hepatic fat content measured by magnetic resonance spectroscopy (MRI) | from baseline to Week 16 |
| Change in fat content/distribution in the abdominal region measured by MRI | from baseline to Week 16 |
| Change in total body fat content measured by air displacement phlethysmography | from baseline to Week 16 |
| Change in homeostatic indexes of insulin sensitivity assessed by Homeostasis Model Assessment for Insulin Sensitivity (HOMA-IS) | from baseline to Week 16 |
| Change in markers of cardiovascular risk (high sensitivity C-reactive protein, adiponectin, free fatty acid) | from baseline to Week 16 |
| Safety: Incidence of adverse events | 22 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C542437 | aleglitazar |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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