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: August 26, 2014
Last verified: August 2014
  Purpose

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


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


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: September 2011
Primary Completion Date: September 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 45227
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: August 26, 2014
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 September 18, 2014