NCT01728740

Brief Summary

To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 19, 2012

Status Verified

December 1, 2012

Enrollment Period

3 months

First QC Date

November 14, 2012

Last Update Submit

December 18, 2012

Conditions

Diabetes Mellitus, Type II

Keywords

BioequivalenceAcarboseMetforminFDC

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (4)

Acarbose/Metformin FDC

EXPERIMENTAL

Day 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)

Drug: Acarbose/Metformin FDC (BAY81-9783)

Acarbose+Metformin

ACTIVE COMPARATOR

Day 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

Drug: Acarbose (Glucobay, BAYG5421)Drug: Metformin

Acarbose

ACTIVE COMPARATOR

Day 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

Drug: Acarbose (Glucobay, BAYG5421)

Metformin

ACTIVE COMPARATOR

Day 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

Drug: Metformin

Interventions

Acarbose/Metformin FDC (BAY81-9783)DRUG

Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose

Acarbose/Metformin FDC
Acarbose (Glucobay, BAYG5421)DRUG

Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose

AcarboseAcarbose+Metformin
MetforminDRUG

Metformin 500mg, oral, single dose

Acarbose+MetforminMetformin

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index (BMI): 18 to 28 kg/m2 (inclusive)
  • Results of Glycosylated Hemoglobin A1c (HbA1c) value are within the normal range (4.3-5.6%, inclusive)
  • Results of the 75 g oral glucose tolerance test (OGTT) during screening show:
  • Blood glucose before OGTT \<110 mg/dL.
  • Blood glucose 1 hour after glucose loading \<180 mg/dL
  • Blood glucose 2 hours after glucose loading \<140 mg/dL

You may not qualify if:

  • A history of relevant diseases of internal organs (diabetes mellitus, Ileus, Ileus-like symptoms, diseases that may significantly jeopardize body systems
  • Febrile illness within 1 week before drug administration
  • Family history of diabetes (within the second degree of relationship)
  • Known drug hypersensitivity or idiosyncrasy
  • Known severe allergies, non-allergic drug reactions, or multiple drug allergies
  • Habitual medication including Chinese herbal drugs
  • Intake of any drugs within 2 weeks of drug administration of period 1
  • Regular daily consumption of more than 1 L of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form
  • Donation of more than 150 mL of blood within 4 weeks before the screening examination
  • Participation in another clinical trial within 4 weeks before the screening examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

AcarboseMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TrisaccharidesOligosaccharidesPolysaccharidesCarbohydratesBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 14, 2012

First Posted

November 20, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 19, 2012

Record last verified: 2012-12

Locations

KR(1)