Study of RO6807952 in Patients With Diabetes Mellitus Type 2

Diabetes Mellitus Type 2 Clinical Trial

Official title:

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of RO6807952 in Type 2 Diabetic Patients Inadequately Controlled With Metformin Alone

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01516476
• Other study ID #: BP27804
• Status: Terminated
• Phase: Phase 2
• First received: January 12, 2012
• Last updated: November 1, 2016
• Start date: November 2011
• Est. completion date: January 2012

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, double-blind, placebo-controlled, multi-center study will evaluate the efficacy and safety of RO6807952 in patients with diabetes mellitus type 2 inadequately controlled with metformin alone. Patients will be randomized to receive doses of RO6807952, placebo, or liraglutide. The anticipated time on study treatment is 12 weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adult patients >/= 18 and </=70 years of age

• Diagnosis of diabetes mellitus, type 2 for at least 3 months

• Treated with a stable dose of metformin

• Hemoglobin A1c >/=7.0% and </=10.5% at screening

• Fasting plasma glucose </=240 mg/dL at screening

• Body mass index >/=27 kg/m2 and </=42 kg/m2 at screening

• Willing and able to maintain existing diet and exercise habits throughout the study

• C-peptide >1.5 ng/mL at screening

Exclusion Criteria:

• History of significant liver or kidney disease

• History of uncontrolled hypertension

• History of significant cardiovascular disease

• History of significant diabetic complications

• History of significant gastrointestinal conditions

• History of weight loss surgery or procedures involving the gastrointestinal tract

• History of chronic or acute pancreatitis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy 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 for 12 weeks
• RO6807952
multiple doses for 12 weeks
• RO6807952
multiple doses for 12 weeks
• liraglutide
liraglutide for 12 weeks

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	Change in hemoglobin A1c (HA1c)		Baseline and 12 weeks	No
Secondary	Change in fasting plasma glucose		Baseline and 12 weeks	No
Secondary	Safety (incidence of adverse events)		12 weeks	No