NCT00809705

Brief Summary

This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4 weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a paracetamol test at intervals during the study. The anticipated time on study treatment is 3 months, and the target sample size is \<100 individuals.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach
2 countries

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

December 16, 2008

Last Update Submit

November 1, 2016

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • Tmax, log (AUC), log(Cmax)of paracetamol

    Days -1, 1, 5, 29, 33, 78 and 82

Secondary Outcomes (3)

  • Adverse events, laboratory parameters, vital signs

    Throughout study

  • renal function (creatinine clearance, urine volume and electrolytes)

    Throughout study

  • Multiple dose pharmacokinetics of Taspoglutide

    Throughout study

Study Arms (3)

1

EXPERIMENTAL
Drug: taspoglutide

2

EXPERIMENTAL
Drug: taspoglutide

3

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

sc once weekly for 12 weeks

3
taspoglutideDRUG

10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks

2

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 mellitus, treated with stable oral antidiabetic drug therapy for \>=3 months prior to screening;
  • stable weight +/-10% for \>=3 months before screening.

You may not qualify if:

  • type 1 diabetes mellitus;
  • acute gastrointestinal symptoms at screening and/or day -1;
  • clinically relevant cardiovascular, bronchopulmonary, gastrointestinal or neurological disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Berlin, 14050, Germany

Location

Unknown Facility

Neuss, 41460, Germany

Location

Unknown Facility

London, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

taspoglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2008

First Posted

December 17, 2008

Study Start

December 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

GB(1)DE(2)