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Safety issue was identified in the Phase2b D7860C00006 study, evaluating AZD6793 in moderate to very severe COPD participants. D7860C00005 study is temporary halted to amend the design to reflect changes implemented in the ongoing D7860C00006 study
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The purpose of this study is to examine the effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants with Type 2 Diabetes Mellitus.
This is a double-blind, placebo-controlled, 2-period cross-over study conducted at a single study centre to assess the pharmacokinetics and pharmacodynamics (ie, glucose lowering effect) of metformin in participants with T2DM when metformin is administered alone and in combination with multiple doses of AZD6793. This study will consist of 2 treatment periods separated by a washout period of 7 to 14 days.
Approximately 28 eligible participants will be randomized to study intervention such that 24 evaluable participants complete the study (12 participants in each treatment sequence).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | AZD6793 and metformin |
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| Treatment B | Experimental | Placebo and metformin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6793 | Drug | Participants will receive oral doses of metformin with an interval of 12 hours between doses. The morning doses of metformin will be administered together with AZD6793 (Treatment A). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean glucose levels | Mean glucose levels on Day 7 of each treatment period as assessed by Continuous Glucose Monitoring (CGM) | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| CGM Metric (Time in range) | The percentage of time (or hours/day) that blood glucose levels remain within a target | Day 7 of each treatment period |
| CGM Metric (Time in tight range) | A metric measuring the percentage of time blood glucose remains between a pre-defined range. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Neuss | 41460 | Germany |
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Potential participants will be screened to assess their eligibility to enter the study up to 21 days prior to the start of the 14-day outpatient run-in period. Eligible participants will return to the study site for an outpatient visit on Day -14 and enter a 14-day outpatient run-in period. During this period they will receive metformin twice a day. Upon completion of the metformin run-in period, eligible participants will be admitted to the study site on Day -1 of Period 1 and randomized on Day 1 of Period 1 in a 1:1 ratio to one of two treatment sequences, AB or BA. AB being the test compound with metformin first and then metformin alone. BA being metformin alone first and then metformin with the test compound following their respective washout periods. After completion of Day 8 of Period 2, participants will receive a follow-up phone call about 5 days after their discharge.
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Investigators, site staff, sponsor and their representatives will remain blinded to each participant's assigned study intervention throughout the course of the study. In order to maintain this blind, an otherwise uninvolved 3rd party will be responsible for the reconstitution and dispensation of all study intervention and will endeavor to ensure that there are no differences in time taken to dispense following randomization.
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| AZD6793 Placebo | Drug | Participants will receive oral doses of metformin with an interval of 12 hours between doses. The morning doses of metformin will be administered together with AZD6793 placebo (Treatment B). |
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| Day 7 of each treatment period |
| CGM Metric (time below range) | A metric representing the percentage of time and minutes per day spent with blood glucose below a certain range. | Day 7 of each treatment period |
| CGM Metric (time above range) | A metric representing the percentage of time and minutes per day spent with blood glucose above a certain range. | Day 7 of each treatment period |
| CGM Metric (AUC(0-24)) | area under the concentration-time curve from time 0 to 24 hours postdose | Day 7 of each treatment period |
| CGM Measure (Plasma fasting glucose) | A measure of glucose levels when a participant is in a fasting state. | Day 7 of each treatment period |
| CGM Measure (AUC(0-4) after each meal) | area under the concentration-time curve from time 0 to 4 hours postdose after each meal | Day 7 of each treatment period |
| CGM Measure (Total glucose AUC(0-24)) | area under the concentration-time curve from time 0 to 24 hours postdose | Day 7 of each treatment period |
| Metformin Plasma PK (AUC(0-12)) | area under the concentration-time curve from time 0 to 12 hours postdose | Day 7 of each treatment period |
| Metformin Plasma PK (Cmax) | maximum observed concentration | Day 7 of each treatment period |
| Metformin Plasma PK (tmax) | time to reach maximum observed plasma concentration | Day 7 of each treatment period |
| Metformin Plasma PK (t1/2λz) | Terminal elimination half-life | Day 7 of each treatment period |
| Metformin Plasma PK (CL/F) | apparent total body clearance | Day 7 of each treatment period |
| Metformin Plasma PK (Vz/F) | apparent volume of distribution during the terminal phase. | Day 7 of each treatment period |
| Metformin Plasma PK (R AUC(0-12)) | Ratio of test to reference based on AUC(0-12) | Day 7 of each treatment period |
| Metformin Plasma PK (R Cmax) | Ratio of test to reference based on Cmax | Day 7 of each treatment period |
| Metformin Urine PK (Ae(0-12)) | cumulative amount excreted into the urine from time 0 to 12 hours postdose | Day 7 of each treatment period |
| Metformin Urine PK (fe(0-12)) | Percentage of dose excreted unchanged in urine from time zero to 12 hours post-dose | Day 7 of each treatment period |
| Metformin Urine PK (CLR) | renal clearance from plasma | Day 7 of each treatment period |
| AZD6793 plasma PK (AUC(0-24)) | area under the concentration-time curve from time 0 to 24 hours postdose | Days 1 through 7 of each treatment period |
| AZD6793 plasma PK (Cmax) | maximum observed concentration | Days 1 through 7 of each treatment period |
| AZD6793 plasma PK (tmax) | time to reach maximum observed plasma concentration | Days 1 through 7 of each treatment period |
| AZD6793 plasma PK (t1/2λz) | Terminal elimination half-life | Days 1 through 7 of each treatment period |
| AZD6793 plasma PK (Ctrough) | concentration observed immediately prior to dosing | Days 1 through 7 of each treatment period |
| AZD6793 plasma PK (Rac AUC(0-24)) | accumulation ratio based on AUC(0-24) | Days 1 through 7 of each treatment period |
| AZD6793 plasma PK (Rac Cmax) | Accumulation ration based on Cmax | Days 1 through 7 of each treatment period |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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