NCT01388153

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_1 diabetes-mellitus-type-2

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

June 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

1 month

First QC Date

July 4, 2011

Last Update Submit

August 27, 2013

Conditions

Diabetes Mellitus, Type 2

Keywords

Bioequivalence, acarbose, ODT

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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)

    within 4 hours after sucrose load

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

    within 4 hours after sucrose load

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

    within 4 hours after sucrose load

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

    within 4 hours after sucrose load

Study Arms (3)

Arm 1

EXPERIMENTAL
Drug: Acarbose (Glucobay ODT, BAYG5421)

Arm 2

EXPERIMENTAL
Drug: Acarbose (Glucobay ODT, BAYG5421)

Arm 3

ACTIVE COMPARATOR
Drug: Acarbose (Glucobay, BAYG5421)

Interventions

Acarbose (Glucobay ODT, BAYG5421)DRUG

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

Arm 1
Acarbose (Glucobay, BAYG5421)DRUG

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

Arm 3

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Acarbose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TrisaccharidesOligosaccharidesPolysaccharidesCarbohydrates

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

July 4, 2011

First Posted

July 6, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

August 28, 2013

Record last verified: 2013-08

Locations

DE(1)