A Study of RO6807952 in Patients With Diabetes Mellitus Type 2

November 1, 2016 updated by: Hoffmann-La Roche

A Randomized, Placebo-Controlled, Sequential, Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MAR701/RO6807952 in Type 2 Diabetic Patients

This randomized, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6807952. Patients will receive multiple weekly subcutaneous doses of RO6870952. The anticipated time on study treatment is 8 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
    • Ohio
      • Cincinnati, Ohio, United States, 45227

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients, 18 to 70 years of age, inclusive
  • Diagnosis of type 2 diabetes >/=3 months and </=10 years prior to screening
  • Fasting plasma glucose >/=110 mg/dL and </=240 mg/dL
  • Patients on a stable dose of metformin for at least 2 months prior to screening
  • Hemoglobin HbA1c >/=6.5% and </=10.5%
  • Body mass index >/=25 kg/m2 and </=42 kg/m2
  • Systolic blood pressure <155 mmHg and diastolic blood pressure <95 mmHg

Exclusion Criteria:

  • Patients with type 1 diabetes
  • History of significant renal and hepatic diseases
  • History of metabolic acidosis and diabetic gastroparesis
  • History of pancreatitis
  • History of coagulation disorders or unexplained excessive bleeding
  • History of clinically significant cardiovascular disease or severe symptomatic hypoglycemia within 6 months of screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: Placebo
Placebo to RO6807952
EXPERIMENTAL: 1
Drug: RO6807952
Escalating subcutaneous dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety: Incidence of adverse events
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood concentrations of RO6807952
Time Frame: 8 weeks
8 weeks
Effect of RO6807952 on Hemoglobin HbA1c level
Time Frame: 8 weeks
8 weeks
Effect of RO6807952 on glucose level
Time Frame: 8 weeks
8 weeks
Change in meal tolerance test
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

May 18, 2011

First Submitted That Met QC Criteria

May 20, 2011

First Posted (ESTIMATE)

May 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP25742

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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