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Acarbose

Phase 3

Diabetes Mellitus | Small molecule | Metabolic |Bayer AG|Last Updated: Aug 5, 2020

Target and mechanism

ModalitySmall molecule

Also known as Acarbose (Glucobay ODT, BAYG5421), Acarbose (Glucobay, BAYG5421)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment204

FDA Designations

No designations recorded

Clinical trial landscape

Acarbose · 6 trials · 3 indications

Phase 3 2Phase 1 4
NCT03349684Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure PatientsDiabetes Mellitus, Type 2
COMPLETED287 Analytics
NCT01010100Prevent/Delay Development of Type 2 Diabetes in Subjects With Impaired Glucose Homeostasis Treated With Acarbose in Primary CareDiabetes Mellitus
COMPLETED204 Analytics
PHASE3COMPLETED
Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients
Diabetes Mellitus, Type 2
NCT03349684287
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PHASE3COMPLETED
Prevent/Delay Development of Type 2 Diabetes in Subjects With Impaired Glucose Homeostasis Treated With Acarbose in Primary Care
Diabetes Mellitus
NCT01010100204
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Study Endpoints

Primary Endpoints

Absolute change in the levels of glycosylated hemoglobin (HbA1c)
At baseline and at treatment week 16
The principal objective was to determine if the administration of small doses of Acarbose could prevent or delay the appearance of Type 2 DM in a population of subjects with impaired glucose homeostasis.
The main criterion for the evaluation of the primary objective was the proportion of diabetic subjects after three years of treatment and another time after three months of wash-out with placebo.
RatioCmax (serum glucose)
Treatment period 1 and 2, Day-1 and Day 1: 10 minutes, 25 minutes, 40 minutes, 55 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 10 minutes, 3 hours 10 minutes, 4 hours 10 minutes

RatioCmax=Cmax,day1/ Cmax,day-1 Cmax,day-1: Maximum serum glucose after 75g sucrose loading on Day -1 Cmax,day1: Maximum serum glucose after 75g sucrose loading and single dose administration of study drug on Day 1

RatioAUC(0-4) (serum glucose)
Treatment period 1 and 2, Day-1 and Day 1: 10 minutes, 25 minutes, 40 minutes, 55 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 10 minutes, 3 hours 10 minutes, 4 hours 10 minutes

RatioAUC(0-4)=AUC(0-4),day1/AUC(0-4),day-1 AUC (0-4),day1: AUC of serum glucose from time 0 to 4 hours on Day 1 AUC(0-4),day-1: AUC of serum glucose from time 0 to 4 hours on Day -1

Cmax (plasma metformin)
Treatment period 1 and 2: Pre-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 24 hours

Cmax: Maximum observed drug concentration in measured matrix after single dose administration / maximum drug concentration in plasma after single dose administration

AUC (0-tlast) (plasma metformin)
Treatment period 1 and 2: Pre-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 24 hours

AUC (0-tlast): AUC from time 0 to the last data point \> LLOQ (lower limit of quantification)

AUC (plasma metformin)
Treatment period 1 and 2: Pre-dose, 0.5 hour, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 24 hours

AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose

Ratio of postprandial maximum concentration (Cmax) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
within 4 hours after sucrose load
Ratio of postprandial Area Under the Curve (AUC(0 4)) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
within 4 hours after sucrose load
Cmax of metformin
within 24 hours after dosing
AUC(0-tn) of metformin
within 24 hours after dosing
Ratio of postprandial maximum concentration (Cmax) of blood glucose following sucrose load with Glucobay (Day 1) and without Glucobay (Day 0)
within 4 hours after sucrose load
Ratio of postprandial Area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose following sucrose load with Glucobay (Day 1) and without Glucobay (Day 0)
within 4 hours after sucrose load
Difference of postprandial maximum concentration (Cmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2)
within 4 hours after sucrose load
Difference of postprandial Area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2)
within 4 hours after sucrose load

Secondary Endpoints

Responder rates
At week 16
Change in 2-hour postprandial plasma glucose (PPG)
At baseline and at treatment week 16
Change in fasting plasma glucose (FPG) levels
At baseline and at treatment week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Acarbose plus metformin armEXPERIMENTALParticipants received loose combination of acarbose and metformin 3 times daily.
Metformin plus placebo armACTIVE_COMPARATORParticipants received loose combination of placebo and metformin 3 times daily.
Arm 1EXPERIMENTAL -
Arm 2PLACEBO_COMPARATOR -
Treatment A-washout-treatment BEXPERIMENTALSubject will receive a single oral dose of acarbose/metformin FDC (Treatment A, 50 mg acarbose/500 mg metformin) in period 1, followed by a single oral dose of 50mg acarbose and 500mg metformin as loose combination (Treatment B) in period 2. Washout interval between 2 treatment periods was at least 7 days.
Treatment B-washout-treatment AEXPERIMENTALSubject will receive a single oral dose of 50 mg acarbose and 500 mg metformin as loose combination (Treatment B) in period 1, followed by a single oral dose of acarbose/metformin FDC (Treatment A, 50mg acarbose/500 mg metformin) in period 2. Washout interval between 2 treatment periods was at least 7 days.
Acarbose/Metformin FDCEXPERIMENTALDay 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Acarbose/Metformin FDC; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose/Metformin FDC (containing 50 mg Acarbose and 500 mg Metformin)
Acarbose+MetforminACTIVE_COMPARATORDay 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without loose combination of Acarbose and Metformin; Day 1: oral sucrose load plus single dose of 1 tablet each of a loose combination of Acarbose 50 mg and Metformin 500 mg
AcarboseACTIVE_COMPARATORDay 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose 50 mg
MetforminACTIVE_COMPARATORDay 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Metformin 500 mg
Arm 3ACTIVE_COMPARATORDay 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay standard tablet 100 mg; Day 1: oral sucrose load plus Glucobay standard tablet 100 mg taken with water

Interventions

NameTypeDescription
AcarboseDRUGUptitrated in the treatment phase from 50 mg per day for 1 week, followed by 100 mg per day for another week, and 150 mg per day for the rest 14 weeks, oral, with the first mouthful of main meal
MetforminDRUG500 mg 3 times daily, oral, with the first mouthful of main meal
PlaceboDRUGAcarbose matching placebo, oral
Acarbose (Glucobay, BAYG5421)DRUG50 mg TID
Acarbose/Metformin FDC(BAY81-9783)DRUGSingle dose: 50 mg acarbose/500 mg metformin tablet, oral
GlucobayDRUGSingle dose: 50 mg tablet, oral
GlucophageDRUGSingle dose: 500 mg tablet, oral
Acarbose/Metformin FDC (BAY81-9783)DRUGAcarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose
Acarbose (Glucobay ODT, BAYG5421)DRUG -
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Eligibility Criteria

Age Range18 Years to 79 Years
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: * Males and females, aged 18 to less than 80 years * Diabetes mellitus type 2, that is insufficently controlled with metformin defined by HbA1c between 7.0 % and 10.0%, inclusive * Body mass index between 22 and 45 kg/m\^2, inclusive * Women and men of reproductive potential mus...

Countries:ChinaSpainSouth KoreaGermany
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