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A Study of RO6807952 in Patients With Diabetes Mellitus Type 2

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01358929
First received: May 18, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: RO6807952
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood concentrations of RO6807952 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Effect of RO6807952 on Hemoglobin HbA1c level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Effect of RO6807952 on glucose level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in meal tolerance test [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: April 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO6807952
Escalating subcutaneous dose
Placebo Comparator: 2 Drug: Placebo
Placebo to RO6807952

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358929

Locations
United States, California
Chula Vista, California, United States, 91911
United States, Ohio
Cincinnati, Ohio, United States, 45212
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01358929     History of Changes
Other Study ID Numbers: BP25742
Study First Received: May 18, 2011
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013