NCT00961909

Brief Summary

This randomized, double-blind, placebo-controlled study will assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO5095932 subcutaneously once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current stable doses of metformin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

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

Timeline
Completed

Started Jun 2009

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

Geographic Reach
1 country

6 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

Study Start

First participant enrolled

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

August 18, 2009

Last Update Submit

November 1, 2016

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability: AEs, laboratory parameters, ECG, body weight, vital signs

    monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up

  • Change in hemoglobin A1c (HbA1c)

    from baseline to week 6

Secondary Outcomes (2)

  • Pharmacokinetics: blood concentration of RO5095932 after multiple dosing

    multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up

  • Change in metabolic parameters: glucose, insulin, C-peptide

    assessed after 4 or 6 weeks on study treatment

Study Arms (4)

1active

EXPERIMENTAL
Drug: RO5095932Drug: metformin

1placebo

PLACEBO COMPARATOR
Drug: metforminDrug: placebo

2active

EXPERIMENTAL
Drug: RO5095932Drug: metformin

2placebo

PLACEBO COMPARATOR
Drug: metforminDrug: placebo

Interventions

RO5095932DRUG

cohorts receiving multiple ascending doses, sc once weekly for 4 weeks

1active
metforminDRUG

stable dose

1active1placebo2active2placebo
placeboDRUG

sc once weekly for 4 weeks

1placebo2placebo

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
  • females who are either surgically sterile or post-menopausal
  • type 2 diabetes treated with a stable dose of metformin
  • BMI between 25-39kg/m2
  • HbA1c between 7 and 10%
  • fasting plasma glucose between 7 and 13.3mmol/L

You may not qualify if:

  • history of clinically significant cardiovascular disease
  • history of clinically significant hepatic or renal disease or impairment
  • recent therapy with insulin, thiazolidinedione, glucagon-like peptide-1 analogues, amylin analogues and/or DPP-IV inhibitors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Anaheim, California, 92801, United States

Location

Unknown Facility

Chula Vista, California, 91911, United States

Location

Unknown Facility

Fort Myers, Florida, 33901, United States

Location

Unknown Facility

Miramar, Florida, 33025, United States

Location

Unknown Facility

San Antonio, Texas, 78209, United States

Location

Unknown Facility

San Antonio, Texas, 78229-4801, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2009

First Posted

August 19, 2009

Study Start

June 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(6)