NCT00517465

Brief Summary

This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2 diabetes mellitus. The starting dose of R1511 will be 100mg po bid for 5 1/2 days; this dose will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability, pharmacokinetic and pharmacodynamic data of the previous dose. 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
41

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_1 diabetes-mellitus-type-2

Geographic Reach
4 countries

8 active sites

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

First Submitted

Initial submission to the registry

August 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2007

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

August 16, 2007

Last Update Submit

November 1, 2016

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (2)

  • AEs, laboratory parameters, vital signs.

    Throughout study

  • Glucose AUC

    Days -1, 1 and 8.

Secondary Outcomes (4)

  • Insulin, C-peptide, glucagon and GLP-1 AUC

    Days -1, 1 and 8

  • 24h glucose

    Days -1, 1 and 8

  • Lipid profiles

    Days -1 and 8

  • Pharmacokinetic parameters

    Days 1 and 8

Study Arms (4)

1

EXPERIMENTAL
Drug: RG1511

2

EXPERIMENTAL
Drug: RG1511

3

EXPERIMENTAL
Drug: RG1511

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

po bid

4
RG1511DRUG

Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.

123

Eligibility Criteria

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

You may qualify if:

  • adult patients, 18-65 years of age;
  • type 2 diabetic patients;
  • naive to anti-diabetic therapy, or taken off current anti-diabetic therapy for \>=2 weeks before first treatment.

You may not qualify if:

  • type 1 diabetes mellitus;
  • clinically significant cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Berlin, 14050, Germany

Location

Unknown Facility

Neuss, 41460, Germany

Location

Unknown Facility

Balatonfüred, 8230, Hungary

Location

Unknown Facility

Budapest, 1027, Hungary

Location

Unknown Facility

Bratislava, 82108, Slovakia

Location

Unknown Facility

Bratislava, 833 05, Slovakia

Location

Unknown Facility

Slough, SL1 4AA, United Kingdom

Location

Unknown Facility

Welwyn Garden City, AL7 1TW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

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 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 17, 2007

Study Start

September 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

GB(2)SL(2)HU(2)DE(2)