A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus

Diabetes Mellitus Type 2 Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group, 2-Part Study to Investigate the Safety, Tolerability, PK, and PD of Once Weekly RO5095932 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00961909
• Other study ID #: NP22340
• Status: Completed
• Phase: Phase 1
• First received: August 18, 2009
• Last updated: November 1, 2016
• Start date: June 2009
• Est. completion date: October 2010

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 study will assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO5095932 subcutaneously once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current stable doses of metformin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-65 years of age

• females who are either surgically sterile or post-menopausal

• type 2 diabetes treated with a stable dose of metformin

• BMI between 25-39kg/m2

• HbA1c between 7 and 10%

• fasting plasma glucose between 7 and 13.3mmol/L

Exclusion Criteria:

• history of clinically significant cardiovascular disease

• history of clinically significant hepatic or renal disease or impairment

• recent therapy with insulin, thiazolidinedione, glucagon-like peptide-1 analogues, amylin analogues and/or DPP-IV inhibitors

Study Design

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:
• RO5095932
cohorts receiving multiple ascending doses, sc once weekly for 4 weeks
• RO5095932
dose titration to target dose, sc once weekly for 6 weeks
• metformin
stable dose
• placebo
sc once weekly for 4 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	Safety and tolerability: AEs, laboratory parameters, ECG, body weight, vital signs		monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up	No
Primary	Change in hemoglobin A1c (HbA1c)		from baseline to week 6	No
Secondary	Pharmacokinetics: blood concentration of RO5095932 after multiple dosing		multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up	No
Secondary	Change in metabolic parameters: glucose, insulin, C-peptide		assessed after 4 or 6 weeks on study treatment	No