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Clinical Trials/NCT01358929
NCT01358929CompletedPhase 1

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

Hoffmann-La Roche0 sites45 target enrollmentStarted: April 2011Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
45
Primary Endpoint
Safety: Incidence of adverse events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

Intervention: RO6807952 (Drug)

2

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Safety: Incidence of adverse events

Time Frame: 8 weeks

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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