A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus

Diabetes Mellitus Type 2 Clinical Trial

Official title:

A Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled 12-week Study to Investigate Glycemic Parameters of Efficacy, Safety/ Tolerability and Pharmacokinetics of Five Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800176
• Other study ID #: BC21587
• Secondary ID: 2008-001249-24
• Status: Completed
• Phase: Phase 2
• Start date: January 22, 2009
• Est. completion date: October 28, 2009

Study information

• Verified date: November 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take their usual dose of metformin throughout the study.The anticipated time on study treatment is <=3 months

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: October 28, 2009
• Est. primary completion date: October 28, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-75 years of age;

• type 2 diabetes, diagnosed for >=3 months;

• either treated with diet, exercise and stable metformin, or with diet and exercise alone.

Exclusion Criteria:

• type 1 diabetes mellitus;

• currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin;

• currently or within 6 months prior to screening treated with any PPARgamma agonist;

• uncontrolled hypertension;

• significant pre-diagnosed diabetic complications requiring treatment.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Placebo
po daily for 12 weeks
• RO4998452
2.5mg po daily for 12 weeks
• RO4998452
5mg po daily for 12 weeks
• RO4998452
10mg po daily for 12 weeks
• RO4998452
20mg po daily for 12 weeks
• RO4998452
40mg po daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Germany,  Hong Kong,  Japan,  Latvia,  Mexico,  Romania,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change in HbA1c		Baseline, Week 4, Week 8 and Week 12
Secondary	Change From Baseline in Fasting Plasma Glucose (mmol/L)		Baseline and Week 12
Secondary	Change From Baseline in Mean Daily Glucose Concentration (mmol/L)		Baseline and Week 12
Secondary	Change From Baseline in Fructosamine Concentration (µmol/L)		Baseline and 12 weeks
Secondary	Change From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)		Baseline and Week 12
Secondary	Change From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)		Baseline and Week 12
Secondary	Change From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)		Baseline and Week 12
Secondary	Change From Baseline in Body Weight (kg)		Baseline and Week 12
Secondary	Percentage of Participants Treated to Target HbA1c < 7%		Baseline up to 12 weeks
Secondary	Percentage of Participants Treated to Target HbA1c < 6.5%		Baseline up to 12 weeks
Secondary	Percentage of Participants With at Least One Adverse Event		Baseline up to 12 weeks