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: April 7, 2014
Last verified: April 2014

May 18, 2011
April 7, 2014
April 2011
September 2011   (final data collection date for primary outcome measure)
Safety: Incidence of adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01358929 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: RO6807952
    Escalating subcutaneous dose
  • Drug: Placebo
    Placebo to RO6807952
  • Experimental: 1
    Intervention: Drug: RO6807952
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01358929
BP25742
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP