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

Phase 2

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: RO4998452; Drug: Placebo

• Registration Number: NCT00800176
• Lead Sponsor: Hoffmann-La Roche

Brief 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2008-12-01
• Study First Submitted QC: 2008-12-01
• Study First Posted: 2008-12-02
• Study Start: 2009-01-22
• Primary Completion: 2009-10-28
• Study Completion: 2009-10-28
• Disposition First Submitted: 2016-07-26
• Disposition First Submitted QC: 2016-07-26
• Disposition First Posted: 2016-07-28
• Results First Submitted: 2020-09-09
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-13
• Last Update Submitted: 2020-11-13
• Results First Posted: 2020-11-18
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 394

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RO4998452 40mg	RO4998452	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
RO4998452 20mg	RO4998452	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.
RO4998452 10mg	RO4998452	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.
RO4998452 2.5mg	RO4998452	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
Placebo	Placebo	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.
RO4998452 5mg	RO4998452	During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.

Primary Outcome Measures

Name	Time	Method
Absolute Change in HbA1c	Baseline, Week 4, Week 8 and Week 12

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Daily Glucose Concentration (mmol/L)	Baseline and Week 12
Percentage of Participants Treated to Target HbA1c < 6.5%	Baseline up to 12 weeks
Change From Baseline in Fasting Plasma Glucose (mmol/L)	Baseline and Week 12
Change From Baseline in Fructosamine Concentration (μmol/L)	Baseline and 12 weeks
Change From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)	Baseline and Week 12
Change From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)	Baseline and Week 12
Change From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)	Baseline and Week 12
Change From Baseline in Body Weight (kg)	Baseline and Week 12
Percentage of Participants Treated to Target HbA1c < 7%	Baseline up to 12 weeks
Percentage of Participants With at Least One Adverse Event	Baseline up to 12 weeks