NCT00437606

Brief Summary

This study will investigate the effect of hepatic impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of GK Activator (2) in type 2 diabetes patients with mild and moderate hepatic impairment. Patients with type 2 diabetes, and with normal hepatic function, or mild or moderate hepatic impairment, will receive a single dose of GK Activator (2) 100mg po before breakfast, for assessment of pharmacokinetic, pharmacodynamic and safety parameters. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

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

Timeline
Completed

Started Mar 2007

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

Geographic Reach
2 countries

3 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

February 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

February 19, 2007

Last Update Submit

August 23, 2016

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • AUCo-inf and Cmax of plasma and urine GK Activator (2) and M4. AUC0-6 of plasma glucose.

    Days 1, 8 and 15

Secondary Outcomes (2)

  • tmax, AUC0-6, AUC0-last, t1/2, CL/F, Ac, CL for GK Activator (2) and M4. Cmin, Cmax, tmax and tmin of plasma glucose.

    Days 1, 8 and 15

  • AEs, laboratory parameters.

    Throughout study

Study Arms (3)

1

EXPERIMENTAL
Drug: GK Activator (2)

2

EXPERIMENTAL
Drug: Ethanol

3

EXPERIMENTAL
Drug: GK Activator (2)Drug: Ethanol

Interventions

GK Activator (2)DRUG

100mg po

13
EthanolDRUG

40g po

23

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, 18-75 years of age;
  • type 2 diabetes;
  • normal hepatic function, or mild or moderate hepatic impairment.

You may not qualify if:

  • type 1 diabetes, or latent autoimmune diabetes in adults;
  • diabetic neuropathy, retinopathy or nephropathy;
  • treatment with insulin or PPAR gamma agonist within 6 weeks of screening;
  • clinically significant cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Bratislava, Slovakia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 19, 2007

First Posted

February 21, 2007

Study Start

March 1, 2007

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

August 24, 2016

Record last verified: 2016-08

Locations

DE(2)SL(1)