Trial · NCT04504045
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in Metabolic Rate of Midazolam (CYP3A4) at Week 3. | Baseline and Week 3. | Change in activity of the drug metabolizing enzyme CYP3A4 following treatment with the glucose lowering drug metformin in 3 weeks. Assessment of the change is based on a change in the metabolic rate, which is the ratio between the concentration of midazolam and its primary metabolite is plasma (Probe drug for CYP3A4). |
| Primary | Change from Baseline in Metabolic Rate of Midazolam (CYP3A4) at Week 12. | Baseline and Week 12. | Change in activity of the drug metabolizing enzyme CYP3A4 following treatment with the glucose lowering drug metformin in 12 weeks. Assessment of the change is based on a change in the metabolic rate, which is the ratio between the concentration of midazolam and its primary metabolite is plasma (Probe drug for CYP3A4). |
| Secondary | Change from Baseline in Metabolic Rate of Caffeine (CYP1A2) at Week 3. | Baseline and Week 3. | Change in activity of the drug metabolizing enzymes CYP1A2 following treatment with the glucose lowering drug metformin after 3 weeks. The change in activity is based on the metabolic rate for the probe drug caffeine. |
| Secondary | Change from Baseline in Metabolic Rate of Caffeine (CYP1A2) at Week 12. | Baseline and Week 12. | Change in activity of the drug metabolizing enzymes CYP1A2 following treatment with the glucose lowering drug metformin after 12 weeks. The change in activity is based on the metabolic rate for the probe drug caffeine. |
| Secondary | Change from Baseline in Metabolic Rate of Efavirenz (CYP2B6) at Week 3. | Baseline and Week 3. | Change in activity of the drug metabolizing enzymes CYP2B6 following treatment with the glucose lowering drug metformin after 3 weeks. The change in activity is based on the metabolic rate for the probe drug Efavirenz. |
| Secondary | Change from Baseline in Metabolic Rate of Efavirenz (CYP2B6) at Week 12. | Baseline and Week 12. | Change in activity of the drug metabolizing enzymes CYP2B6 following treatment with the glucose lowering drug metformin after 12 weeks. The change in activity is based on the metabolic rate for the probe drug Efavirenz. |
| Secondary | Change from Baseline in Metabolic Rate of Losartan (CYP2C9) at Week 3. | Baseline and Week 3. | Change in activity of the drug metabolizing enzymes CYP2C9 following treatment with the glucose lowering drug metformin after 3 weeks. The change in activity is based on the metabolic rate for the probe drug Losartan. |
| Secondary | Change from Baseline in Metabolic Rate of Losartan (CYP2C9) at Week 12. | Baseline and Week 12. | Change in activity of the drug metabolizing enzymes CYP2C9 following treatment with the glucose lowering drug metformin after 12 weeks. The change in activity is based on the metabolic rate for the probe drug Losartan. |
| Secondary | Change from Baseline in Metabolic Rate of Omeprazole (CYP2C19) at Week 3. | Baseline and Week 3. | Change in activity of the drug metabolizing enzymes CYP2C19 following treatment with the glucose lowering drug metformin after 3 weeks. The change in activity is based on the metabolic rate for the probe drug Omeprazole. |
| Secondary | Change from Baseline in Metabolic Rate of Omeprazole (CYP2C19) at Week 12. | Baseline and Week 12. | Change in activity of the drug metabolizing enzymes CYP2C19 following treatment with the glucose lowering drug metformin after 12 weeks. The change in activity is based on the metabolic rate for the probe drug Omeprazole. |
| Secondary | Change from Baseline in Metabolic Rate of Metoprolol (CYP2D6) at Week 3. | Baseline and Week 3. | Change in activity of the drug metabolizing enzymes CYP2D6 following treatment with the glucose lowering drug metformin after 3 weeks. The change in activity is based on the metabolic rate for the probe drug Metoprolol. |
| Secondary | Change from Baseline in Metabolic Rate of Metoprolol (CYP2D6) at Week 12. | Baseline and Week 12. | Change in activity of the drug metabolizing enzymes CYP2D6 following treatment with the glucose lowering drug metformin after 12 weeks. The change in activity is based on the metabolic rate for the probe drug Metoprolol. |
| Secondary | Change from Baseline in HbA1c at Week 3. | Baseline and Week 3. | Change in the regulation of blood glucose over time assessed by HbA1c |
| Secondary | Change from Baseline in HbA1c at Week 12. | Baseline and Week 12. | Change in the regulation of blood glucose over time assessed by HbA1c |
| Secondary | Change from Baseline in insulin resistance at Week 3. | Baseline and Week 3. | An oral glucose tolerance test will be performed and glucose, insulin and c-peptide will be measured and combined by the Homeostatic Model Assessment (HOMA) to report insulin resistance. |
| Secondary | Change from Baseline in insulin resistance at Week 12. | Baseline and Week 12. | An oral glucose tolerance test will be performed and glucose, insulin and c-peptide will be measured and combined by the Homeostatic Model Assessment (HOMA) to report insulin resistance. |
| Secondary | Change from Baseline in Interleukin-1-B at Week 3. | Baseline and Week 3. | Change in patients inflammatory status assessed by measurement of Interleukin-1-B. |
| Secondary | Change from Baseline in Interleukin-1-B at Week 12. | Baseline and Week 12. | Change in patients inflammatory status assessed by measurement of Interleukin-1-B. |
| Secondary | Change from Baseline in Interleukin-2 at Week 3. | Baseline and Week 3. | Change in patients inflammatory status assessed by measurement of Interleukin-2. |
| Secondary | Change from Baseline in Interleukin-2 at Week 12. | Baseline and Week 12. | Change in patients inflammatory status assessed by measurement of Interleukin-2. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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