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CompletedNCT01388153Updated Aug 28, 2013

A 3-fold Crossover Bioequivalence Study Between Glucobay Orally Disintegrating Tablet (ODT) and Glucobay Standard Tablet

A Phase 1 interventional study of Acarbose (Glucobay ODT, BAYG5421) and Acarbose (Glucobay ODT, BAYG5421) in Diabetes Mellitus, Type 2, sponsored by Bayer. Completed at 1 site in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-28.

Sponsored by Bayer · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) taken without or with water and the Glucobay standard tablet taken with water

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Bioequivalence, acarbose, ODT
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 33 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • The informed consent must be signed before any study specific tests or procedures are done
  • Healthy male subject
  • Age: 18 to 45 years (inclusive) at the first screening examination / visit
  • Ethnicity: White
  • Body mass index (BMI): above/equal 18 and below/equal 28 kg / m²
  • Confirmation of the subject's health insurance coverage prior to the first screening examination / visit
  • Ability to understand and follow study-related instructions

Exclusion criteria

Exclusion Criteria:

  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
  • Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
  • Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
  • Known severe allergies, non-allergic drug reactions, or multiple drug allergies
  • Chronic intestinal disorders associated with distinct disturbances of digestion and absorption
  • States which may deteriorate as a result of increased gas formation in the intestine (e.g. Roemheld´s syndrome, major hernias, intestinal obstructions, intestinal ulcers, Crohn´s disease, ulcerative colitis, malabsorptions)
  • Fasting blood glucose level outside normal range
  • Impaired glucose tolerance in glucose tolerance test
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: Acarbose (Glucobay ODT, BAYG5421)

  • Experimental
    Arm 2

    Drug: Acarbose (Glucobay ODT, BAYG5421)

  • Active comparator
    Arm 3

    Drug: Acarbose (Glucobay, BAYG5421)

Interventions

  • DrugAcarbose (Glucobay ODT, BAYG5421)

    Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT; Day 2: oral sucrose load plus Glucobay ODT taken without water

  • DrugAcarbose (Glucobay ODT, BAYG5421)

    Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT; Day 2: oral sucrose load plus Glucobay ODT taken with water

  • DrugAcarbose (Glucobay, BAYG5421)

    Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay standard tablet; Day 2: oral sucrose load plus Glucobay standard tablet taken with water

06

What researchers measure

Primary outcomes

  1. Difference of postprandial maximum concentration (Cmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2)

    Time frame: within 4 hours after sucrose load

  2. 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)

    Time frame: within 4 hours after sucrose load

Secondary outcomes

  1. Time to reach maximum drug concentration in plasma after single dose (tmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2)

    Time frame: within 4 hours after sucrose load

  2. Difference of postprandial Cmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)

    Time frame: within 4 hours after sucrose load

  3. Difference of postprandial AUC(0-4) of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)

    Time frame: within 4 hours after sucrose load

  4. Tmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)

    Time frame: within 4 hours after sucrose load

07

Study locations

1 site
  • Mönchengladbach, Nordrhein-Westfalen 41061, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01388153
Lead sponsor
Bayer
First posted
Jul 6, 2011
Start date
Jun 2011
Primary completion
Jul 2011
Completion
Aug 2011
Last update
Aug 28, 2013

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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