A Study of RO6807952 in Patients With Diabetes Mellitus Type 2

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01358929

Enrollment

Registered

2011-05-24

Start date

2011-04-30

Completion date

2011-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

Brief summary

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.

Interventions

DRUGPlacebo

Placebo to RO6807952

DRUGRO6807952

Escalating subcutaneous dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of adverse events	8 weeks

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026