Phase 2
N=394
A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus
Diabetes Mellitus Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00800176 ↗Enrolled (actual)
394
Serious AEs
1.0%
Results posted
Nov 2020
Primary outcome: Primary: Absolute Change in HbA1c — 7.872; 7.939; 8.006; 7.998 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); RO4998452 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in HbA1c |
7.872; 7.939; 8.006; 7.998; 7.919; 7.933 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (mmol/L) |
8.738; 8.917; 8.695; 8.824; 8.741; 8.992 | — |
| SECONDARY Change From Baseline in Mean Daily Glucose Concentration (mmol/L) |
9.655; 9.546; 9.750; 9.843; 9.614; 9.648 | — |
| SECONDARY Change From Baseline in Fructosamine Concentration (μmol/L) |
293.292; 294.891; 292.600; 290.970; 292.672; 305.015 | — |
| SECONDARY Change From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L) |
11.663; 11.661; 11.689; 11.432; 11.643; 12.032 | — |
| SECONDARY Change From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L) |
201.243; 202.269; 207.255; 223.964; 219.396; 189.286 | — |
| SECONDARY Change From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L) |
6.607; 8.472; 6.841; 11.659; 14.039; 10.395 | — |
| SECONDARY Change From Baseline in Body Weight (kg) |
83.965; 85.455; 82.149; 83.411; 84.914; 81.568 | — |
| SECONDARY Percentage of Participants Treated to Target HbA1c < 7% |
13.8; 17.2; 23.1; 24.2; 34.4; 40.9 | — |
| SECONDARY Percentage of Participants Treated to Target HbA1c < 6.5% |
3.1; 6.3; 9.2; 6.1; 10.9; 16.7 | — |
| SECONDARY Percentage of Participants With at Least One Adverse Event |
37.9; 36.4; 46.2; 37.9; 35.9; 46.3 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00800176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.