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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
28
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).
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).
Research Site
Neuss, Germany
Mean glucose levels
Mean glucose levels on Day 7 of each treatment period as assessed by Continuous Glucose Monitoring (CGM)
Time frame: Day 7
CGM Metric (Time in range)
The percentage of time (or hours/day) that blood glucose levels remain within a target
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 7 of each treatment period
CGM Metric (AUC(0-24))
area under the concentration-time curve from time 0 to 24 hours postdose
Time frame: Day 7 of each treatment period
CGM Measure (Plasma fasting glucose)
A measure of glucose levels when a participant is in a fasting state.
Time frame: Day 7 of each treatment period
CGM Measure (AUC(0-4) after each meal)
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area under the concentration-time curve from time 0 to 4 hours postdose after each meal
Time frame: 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
Time frame: 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
Time frame: Day 7 of each treatment period
Metformin Plasma PK (Cmax)
maximum observed concentration
Time frame: Day 7 of each treatment period
Metformin Plasma PK (tmax)
time to reach maximum observed plasma concentration
Time frame: Day 7 of each treatment period
Metformin Plasma PK (t1/2λz)
Terminal elimination half-life
Time frame: Day 7 of each treatment period
Metformin Plasma PK (CL/F)
apparent total body clearance
Time frame: Day 7 of each treatment period
Metformin Plasma PK (Vz/F)
apparent volume of distribution during the terminal phase.
Time frame: Day 7 of each treatment period
Metformin Plasma PK (R AUC(0-12))
Ratio of test to reference based on AUC(0-12)
Time frame: Day 7 of each treatment period
Metformin Plasma PK (R Cmax)
Ratio of test to reference based on Cmax
Time frame: 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
Time frame: 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
Time frame: Day 7 of each treatment period
Metformin Urine PK (CLR)
renal clearance from plasma
Time frame: 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
Time frame: Days 1 through 7 of each treatment period
AZD6793 plasma PK (Cmax)
maximum observed concentration
Time frame: Days 1 through 7 of each treatment period
AZD6793 plasma PK (tmax)
time to reach maximum observed plasma concentration
Time frame: Days 1 through 7 of each treatment period
AZD6793 plasma PK (t1/2λz)
Terminal elimination half-life
Time frame: Days 1 through 7 of each treatment period
AZD6793 plasma PK (Ctrough)
concentration observed immediately prior to dosing
Time frame: Days 1 through 7 of each treatment period
AZD6793 plasma PK (Rac AUC(0-24))
accumulation ratio based on AUC(0-24)
Time frame: Days 1 through 7 of each treatment period
AZD6793 plasma PK (Rac Cmax)
Accumulation ration based on Cmax
Time frame: Days 1 through 7 of each treatment period