A Study of RO6807952 in Patients With Diabetes Mellitus Type 2

Diabetes Mellitus Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358929
• Other study ID #: BP25742
• Status: Completed
• Phase: Phase 1
• First received: May 18, 2011
• Last updated: November 1, 2016
• Start date: April 2011
• Est. completion date: September 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo
Placebo to RO6807952
• RO6807952
Escalating subcutaneous dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		8 weeks	No
Secondary	Blood concentrations of RO6807952		8 weeks	No
Secondary	Effect of RO6807952 on Hemoglobin HbA1c level		8 weeks	No
Secondary	Effect of RO6807952 on glucose level		8 weeks	No
Secondary	Change in meal tolerance test		8 weeks	No