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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00800176
Enrollment
394
Registered
2008-12-02
Start date
2009-01-22
Completion date
2009-10-28
Last updated
2020-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

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

Interventions

DRUGPlacebo

po daily for 12 weeks

DRUGRO4998452

2.5mg po daily for 12 weeks

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Absolute Change in HbA1cBaseline, Week 4, Week 8 and Week 12

Secondary

MeasureTime frame
Change From Baseline in Mean Daily Glucose Concentration (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 Mean Insulin Concentration (mmol/L)Baseline and Week 12
Change From Baseline in Fasting Plasma Glucose (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 Treated to Target HbA1c < 6.5%Baseline up to 12 weeks
Percentage of Participants With at Least One Adverse EventBaseline up to 12 weeks
Change From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)Baseline and Week 12

Countries

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

Participant flow

Recruitment details

Screening period: Week 6 to 5 prior to randomization

Pre-assignment details

As soon as the results of the screening tests were available, eligible patients could start the 4-week placebo run-in period (visit week -4). A diet and exercise plan was discussed based on the recommendations of the investigator. This plan was not to be changed during the study

Participants by arm

ArmCount
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.
66
RO4998452 2.5 mg
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.
66
RO4998452 5mg
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.
65
RO4998452 10mg
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.
66
RO4998452 20mg
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.
64
RO4998452 40mg
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.
67
Total394

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Overall StudyAdverse Event210211
Overall StudyFailure to return330200
Overall StudyOther100020
Overall StudyRefused treatment320014

Baseline characteristics

CharacteristicPlaceboTotalRO4998452 40mgRO4998452 20mgRO4998452 10mgRO4998452 5mgRO4998452 2.5 mg
Age, Continuous53.9 Years
STANDARD_DEVIATION 11.12
55.1 Years
STANDARD_DEVIATION 10.34
57.5 Years
STANDARD_DEVIATION 9.31
56.3 Years
STANDARD_DEVIATION 9.79
54.5 Years
STANDARD_DEVIATION 10.7
54.8 Years
STANDARD_DEVIATION 10.53
53.3 Years
STANDARD_DEVIATION 10.86
Ethnicity (NIH/OMB)
Hispanic or Latino
42 Participants253 Participants39 Participants45 Participants40 Participants41 Participants46 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants141 Participants28 Participants19 Participants26 Participants24 Participants20 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Ex-Japan
54 Participants323 Participants54 Participants53 Participants54 Participants53 Participants55 Participants
Race/Ethnicity, Customized
Japan
12 Participants71 Participants13 Participants11 Participants12 Participants12 Participants11 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
18 Participants93 Participants19 Participants13 Participants15 Participants14 Participants14 Participants
Race (NIH/OMB)
Black or African American
1 Participants6 Participants0 Participants2 Participants2 Participants1 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants42 Participants9 Participants4 Participants9 Participants9 Participants6 Participants
Race (NIH/OMB)
White
42 Participants253 Participants39 Participants45 Participants40 Participants41 Participants46 Participants
Sex: Female, Male
Female
30 Participants185 Participants36 Participants21 Participants32 Participants34 Participants32 Participants
Sex: Female, Male
Male
36 Participants209 Participants31 Participants43 Participants34 Participants31 Participants34 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
25 / 6624 / 6630 / 6525 / 6623 / 6431 / 67
serious
Total, serious adverse events
1 / 662 / 660 / 650 / 660 / 641 / 67

Outcome results

Primary

Absolute Change in HbA1c

Time frame: Baseline, Week 4, Week 8 and Week 12

Population: Full analysis set included all patients who were randomized, received at least one dose of study medication, and had an evaluable baseline and at least one evaluable post baseline measurement of HbA1c. If patient's HbA1c value at baseline visit was missing, latest screening HbA1c value was used as baseline. If patient received an incorrect dose of study medication at any time during study, patient was analyzed according to dose patient was randomized to, not dose patient received.

ArmMeasureGroupValue (MEAN)
PlaceboAbsolute Change in HbA1cBaseline7.872 Percentage
PlaceboAbsolute Change in HbA1cWeek 4-0.238 Percentage
PlaceboAbsolute Change in HbA1cWeek 8-0.280 Percentage
PlaceboAbsolute Change in HbA1cWeek 12-0.269 Percentage
RO4998452 2.5 mgAbsolute Change in HbA1cBaseline7.939 Percentage
RO4998452 2.5 mgAbsolute Change in HbA1cWeek 8-0.468 Percentage
RO4998452 2.5 mgAbsolute Change in HbA1cWeek 4-0.394 Percentage
RO4998452 2.5 mgAbsolute Change in HbA1cWeek 12-0.440 Percentage
RO4998452 5mgAbsolute Change in HbA1cWeek 4-0.460 Percentage
RO4998452 5mgAbsolute Change in HbA1cBaseline8.006 Percentage
RO4998452 5mgAbsolute Change in HbA1cWeek 12-0.617 Percentage
RO4998452 5mgAbsolute Change in HbA1cWeek 8-0.611 Percentage
RO4998452 10mgAbsolute Change in HbA1cWeek 4-0.539 Percentage
RO4998452 10mgAbsolute Change in HbA1cBaseline7.998 Percentage
RO4998452 10mgAbsolute Change in HbA1cWeek 12-0.694 Percentage
RO4998452 10mgAbsolute Change in HbA1cWeek 8-0.694 Percentage
RO4998452 20mgAbsolute Change in HbA1cWeek 12-0.768 Percentage
RO4998452 20mgAbsolute Change in HbA1cBaseline7.919 Percentage
RO4998452 20mgAbsolute Change in HbA1cWeek 8-0.768 Percentage
RO4998452 20mgAbsolute Change in HbA1cWeek 4-0.516 Percentage
RO4998452 40mgAbsolute Change in HbA1cWeek 4-0.564 Percentage
RO4998452 40mgAbsolute Change in HbA1cBaseline7.933 Percentage
RO4998452 40mgAbsolute Change in HbA1cWeek 8-0.832 Percentage
RO4998452 40mgAbsolute Change in HbA1cWeek 12-0.832 Percentage
Secondary

Change From Baseline in Body Weight (kg)

Time frame: Baseline and Week 12

Population: Full analysis set included all patients who were randomized, received at least one dose of study medication, and had an evaluable baseline and at least one evaluable post baseline measurement of HbA1c. If patient's HbA1c value at baseline visit was missing, latest screening HbA1c value was used as baseline. If patient received an incorrect dose of study medication at any time during study, patient was analyzed according to dose patient was randomized to, not dose patient received.

ArmMeasureGroupValue (MEAN)
PlaceboChange From Baseline in Body Weight (kg)Baseline83.965 kg
PlaceboChange From Baseline in Body Weight (kg)Last Visit: Absolute Change from Baseline-0.741 kg
RO4998452 2.5 mgChange From Baseline in Body Weight (kg)Baseline85.455 kg
RO4998452 2.5 mgChange From Baseline in Body Weight (kg)Last Visit: Absolute Change from Baseline-1.564 kg
RO4998452 5mgChange From Baseline in Body Weight (kg)Baseline82.149 kg
RO4998452 5mgChange From Baseline in Body Weight (kg)Last Visit: Absolute Change from Baseline-1.853 kg
RO4998452 10mgChange From Baseline in Body Weight (kg)Baseline83.411 kg
RO4998452 10mgChange From Baseline in Body Weight (kg)Last Visit: Absolute Change from Baseline-2.235 kg
RO4998452 20mgChange From Baseline in Body Weight (kg)Baseline84.914 kg
RO4998452 20mgChange From Baseline in Body Weight (kg)Last Visit: Absolute Change from Baseline-2.551 kg
RO4998452 40mgChange From Baseline in Body Weight (kg)Baseline81.568 kg
RO4998452 40mgChange From Baseline in Body Weight (kg)Last Visit: Absolute Change from Baseline-2.824 kg
Secondary

Change From Baseline in Fasting Plasma Glucose (mmol/L)

Time frame: Baseline and Week 12

Population: Full analysis set included all patients who were randomized, received at least one dose of study medication, and had an evaluable baseline and at least one evaluable post baseline measurement of HbA1c. If patient's HbA1c value at baseline visit was missing, latest screening HbA1c value was used as baseline. If patient received an incorrect dose of study medication at any time during study, patient was analyzed according to dose patient was randomized to, not dose patient received.

ArmMeasureGroupValue (MEAN)
PlaceboChange From Baseline in Fasting Plasma Glucose (mmol/L)Baseline8.738 mmol/L
PlaceboChange From Baseline in Fasting Plasma Glucose (mmol/L)Last Visit: Change from Baseline-0.502 mmol/L
RO4998452 2.5 mgChange From Baseline in Fasting Plasma Glucose (mmol/L)Baseline8.917 mmol/L
RO4998452 2.5 mgChange From Baseline in Fasting Plasma Glucose (mmol/L)Last Visit: Change from Baseline-0.021 mmol/L
RO4998452 5mgChange From Baseline in Fasting Plasma Glucose (mmol/L)Baseline8.695 mmol/L
RO4998452 5mgChange From Baseline in Fasting Plasma Glucose (mmol/L)Last Visit: Change from Baseline-0.641 mmol/L
RO4998452 10mgChange From Baseline in Fasting Plasma Glucose (mmol/L)Baseline8.824 mmol/L
RO4998452 10mgChange From Baseline in Fasting Plasma Glucose (mmol/L)Last Visit: Change from Baseline-1.042 mmol/L
RO4998452 20mgChange From Baseline in Fasting Plasma Glucose (mmol/L)Baseline8.741 mmol/L
RO4998452 20mgChange From Baseline in Fasting Plasma Glucose (mmol/L)Last Visit: Change from Baseline-0.935 mmol/L
RO4998452 40mgChange From Baseline in Fasting Plasma Glucose (mmol/L)Baseline8.992 mmol/L
RO4998452 40mgChange From Baseline in Fasting Plasma Glucose (mmol/L)Last Visit: Change from Baseline-1.422 mmol/L
Secondary

Change From Baseline in Fructosamine Concentration (μmol/L)

Time frame: Baseline and 12 weeks

Population: Full analysis set included all patients who were randomized, received at least one dose of study medication, and had an evaluable baseline and at least one evaluable post baseline measurement of HbA1c. If patient's HbA1c value at baseline visit was missing, latest screening HbA1c value was used as baseline. If patient received an incorrect dose of study medication at any time during study, patient was analyzed according to dose patient was randomized to, not dose patient received.

ArmMeasureGroupValue (MEAN)
PlaceboChange From Baseline in Fructosamine Concentration (μmol/L)Last Visit: Absolute Change from Baseline-0.368 μmol/L
PlaceboChange From Baseline in Fructosamine Concentration (μmol/L)Baseline293.292 μmol/L
RO4998452 2.5 mgChange From Baseline in Fructosamine Concentration (μmol/L)Baseline294.891 μmol/L
RO4998452 2.5 mgChange From Baseline in Fructosamine Concentration (μmol/L)Last Visit: Absolute Change from Baseline-11.202 μmol/L
RO4998452 5mgChange From Baseline in Fructosamine Concentration (μmol/L)Baseline292.600 μmol/L
RO4998452 5mgChange From Baseline in Fructosamine Concentration (μmol/L)Last Visit: Absolute Change from Baseline-12.992 μmol/L
RO4998452 10mgChange From Baseline in Fructosamine Concentration (μmol/L)Last Visit: Absolute Change from Baseline-16.712 μmol/L
RO4998452 10mgChange From Baseline in Fructosamine Concentration (μmol/L)Baseline290.970 μmol/L
RO4998452 20mgChange From Baseline in Fructosamine Concentration (μmol/L)Baseline292.672 μmol/L
RO4998452 20mgChange From Baseline in Fructosamine Concentration (μmol/L)Last Visit: Absolute Change from Baseline-18.758 μmol/L
RO4998452 40mgChange From Baseline in Fructosamine Concentration (μmol/L)Last Visit: Absolute Change from Baseline-20.619 μmol/L
RO4998452 40mgChange From Baseline in Fructosamine Concentration (μmol/L)Baseline305.015 μmol/L
Secondary

Change From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)

Time frame: Baseline and Week 12

Population: Full analysis set included all patients who were randomized, received at least one dose of study medication, and had an evaluable baseline and at least one evaluable post baseline measurement of HbA1c. If patient's HbA1c value at baseline visit was missing, latest screening HbA1c value was used as baseline. If patient received an incorrect dose of study medication at any time during study, patient was analyzed according to dose patient was randomized to, not dose patient received.

ArmMeasureGroupValue (MEAN)
PlaceboChange From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)Baseline11.663 mmol/L
PlaceboChange From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)Last Visit: Absolute Change from Baseline-0.655 mmol/L
RO4998452 2.5 mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)Baseline11.661 mmol/L
RO4998452 2.5 mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)Last Visit: Absolute Change from Baseline-1.692 mmol/L
RO4998452 5mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)Baseline11.689 mmol/L
RO4998452 5mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)Last Visit: Absolute Change from Baseline-2.146 mmol/L
RO4998452 10mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)Baseline11.432 mmol/L
RO4998452 10mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)Last Visit: Absolute Change from Baseline-2.347 mmol/L
RO4998452 20mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)Baseline11.643 mmol/L
RO4998452 20mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)Last Visit: Absolute Change from Baseline-2.443 mmol/L
RO4998452 40mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)Baseline12.032 mmol/L
RO4998452 40mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L)Last Visit: Absolute Change from Baseline-2.884 mmol/L
Secondary

Change From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)

Time frame: Baseline and Week 12

Population: Full analysis set included all patients who were randomized, received at least one dose of study medication, and had an evaluable baseline and at least one evaluable post baseline measurement of HbA1c. If patient's HbA1c value at baseline visit was missing, latest screening HbA1c value was used as baseline. If patient received an incorrect dose of study medication at any time during study, patient was analyzed according to dose patient was randomized to, not dose patient received.

ArmMeasureGroupValue (MEAN)
PlaceboChange From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)Baseline201.243 mmol/L
PlaceboChange From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)Last Visit: Absolute Change from Baseline-8.909 mmol/L
RO4998452 2.5 mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)Baseline202.269 mmol/L
RO4998452 2.5 mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)Last Visit: Absolute Change from Baseline-46.108 mmol/L
RO4998452 5mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)Baseline207.255 mmol/L
RO4998452 5mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)Last Visit: Absolute Change from Baseline-39.409 mmol/L
RO4998452 10mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)Baseline223.964 mmol/L
RO4998452 10mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)Last Visit: Absolute Change from Baseline-68.881 mmol/L
RO4998452 20mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)Baseline219.396 mmol/L
RO4998452 20mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)Last Visit: Absolute Change from Baseline-67.373 mmol/L
RO4998452 40mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)Baseline189.286 mmol/L
RO4998452 40mgChange From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L)Last Visit: Absolute Change from Baseline-58.053 mmol/L
Secondary

Change From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)

Time frame: Baseline and Week 12

Population: Full analysis set included all patients who were randomized, received at least one dose of study medication, and had an evaluable baseline and at least one evaluable post baseline measurement of HbA1c. If patient's HbA1c value at baseline visit was missing, latest screening HbA1c value was used as baseline. If patient received an incorrect dose of study medication at any time during study, patient was analyzed according to dose patient was randomized to, not dose patient received.

ArmMeasureGroupValue (MEAN)
PlaceboChange From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)Baseline6.607 mmol/L
PlaceboChange From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)Last Visit: Absolute Change from Baseline-1.282 mmol/L
RO4998452 2.5 mgChange From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)Baseline8.472 mmol/L
RO4998452 2.5 mgChange From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)Last Visit: Absolute Change from Baseline43.369 mmol/L
RO4998452 5mgChange From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)Baseline6.841 mmol/L
RO4998452 5mgChange From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)Last Visit: Absolute Change from Baseline52.396 mmol/L
RO4998452 10mgChange From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)Baseline11.659 mmol/L
RO4998452 10mgChange From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)Last Visit: Absolute Change from Baseline68.634 mmol/L
RO4998452 20mgChange From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)Baseline14.039 mmol/L
RO4998452 20mgChange From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)Last Visit: Absolute Change from Baseline62.610 mmol/L
RO4998452 40mgChange From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)Baseline10.395 mmol/L
RO4998452 40mgChange From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L)Last Visit: Absolute Change from Baseline59.294 mmol/L
Secondary

Change From Baseline in Mean Daily Glucose Concentration (mmol/L)

Time frame: Baseline and Week 12

Population: Full analysis set included all patients who were randomized, received at least one dose of study medication, and had an evaluable baseline and at least one evaluable post baseline measurement of HbA1c. If patient's HbA1c value at baseline visit was missing, latest screening HbA1c value was used as baseline. If patient received an incorrect dose of study medication at any time during study, patient was analyzed according to dose patient was randomized to, not dose patient received.

ArmMeasureGroupValue (MEAN)
PlaceboChange From Baseline in Mean Daily Glucose Concentration (mmol/L)Change from Baseline9.655 mmol/L
PlaceboChange From Baseline in Mean Daily Glucose Concentration (mmol/L)Last Visit: Absolute Change from Baseline-0.278 mmol/L
RO4998452 2.5 mgChange From Baseline in Mean Daily Glucose Concentration (mmol/L)Change from Baseline9.546 mmol/L
RO4998452 2.5 mgChange From Baseline in Mean Daily Glucose Concentration (mmol/L)Last Visit: Absolute Change from Baseline-0.556 mmol/L
RO4998452 5mgChange From Baseline in Mean Daily Glucose Concentration (mmol/L)Change from Baseline9.750 mmol/L
RO4998452 5mgChange From Baseline in Mean Daily Glucose Concentration (mmol/L)Last Visit: Absolute Change from Baseline-0.800 mmol/L
RO4998452 10mgChange From Baseline in Mean Daily Glucose Concentration (mmol/L)Change from Baseline9.843 mmol/L
RO4998452 10mgChange From Baseline in Mean Daily Glucose Concentration (mmol/L)Last Visit: Absolute Change from Baseline-1.055 mmol/L
RO4998452 20mgChange From Baseline in Mean Daily Glucose Concentration (mmol/L)Change from Baseline9.614 mmol/L
RO4998452 20mgChange From Baseline in Mean Daily Glucose Concentration (mmol/L)Last Visit: Absolute Change from Baseline-0.882 mmol/L
RO4998452 40mgChange From Baseline in Mean Daily Glucose Concentration (mmol/L)Change from Baseline9.648 mmol/L
RO4998452 40mgChange From Baseline in Mean Daily Glucose Concentration (mmol/L)Last Visit: Absolute Change from Baseline-1.298 mmol/L
Secondary

Percentage of Participants Treated to Target HbA1c < 6.5%

Time frame: Baseline up to 12 weeks

Population: Full analysis set included all patients who were randomized, received at least one dose of study medication, and had an evaluable baseline and at least one evaluable post baseline measurement of HbA1c. If patient's HbA1c value at baseline visit was missing, latest screening HbA1c value was used as baseline. If patient received an incorrect dose of study medication at any time during study, patient was analyzed according to dose patient was randomized to, not dose patient received.

ArmMeasureValue (NUMBER)
PlaceboPercentage of Participants Treated to Target HbA1c < 6.5%3.1 Percentage
RO4998452 2.5 mgPercentage of Participants Treated to Target HbA1c < 6.5%6.3 Percentage
RO4998452 5mgPercentage of Participants Treated to Target HbA1c < 6.5%9.2 Percentage
RO4998452 10mgPercentage of Participants Treated to Target HbA1c < 6.5%6.1 Percentage
RO4998452 20mgPercentage of Participants Treated to Target HbA1c < 6.5%10.9 Percentage
RO4998452 40mgPercentage of Participants Treated to Target HbA1c < 6.5%16.7 Percentage
Secondary

Percentage of Participants Treated to Target HbA1c < 7%

Time frame: Baseline up to 12 weeks

Population: Full analysis set included all patients who were randomized, received at least one dose of study medication, and had an evaluable baseline and at least one evaluable post baseline measurement of HbA1c. If patient's HbA1c value at baseline visit was missing, latest screening HbA1c value was used as baseline. If patient received an incorrect dose of study medication at any time during study, patient was analyzed according to dose patient was randomized to, not dose patient received.

ArmMeasureValue (NUMBER)
PlaceboPercentage of Participants Treated to Target HbA1c < 7%13.8 Percentage
RO4998452 2.5 mgPercentage of Participants Treated to Target HbA1c < 7%17.2 Percentage
RO4998452 5mgPercentage of Participants Treated to Target HbA1c < 7%23.1 Percentage
RO4998452 10mgPercentage of Participants Treated to Target HbA1c < 7%24.2 Percentage
RO4998452 20mgPercentage of Participants Treated to Target HbA1c < 7%34.4 Percentage
RO4998452 40mgPercentage of Participants Treated to Target HbA1c < 7%40.9 Percentage
Secondary

Percentage of Participants With at Least One Adverse Event

Time frame: Baseline up to 12 weeks

Population: The safety population consisted of all patients randomized and received at least one dose of double-blind study medication (DBSM). If patient received incorrect dose of DBSM throughout study, patient was analyzed according to dose actually received. If patient received an incorrect dose of DBSM for only a portion of study, patient was analyzed according to dose patient was randomized to.

ArmMeasureValue (NUMBER)
PlaceboPercentage of Participants With at Least One Adverse Event37.9 Percentage
RO4998452 2.5 mgPercentage of Participants With at Least One Adverse Event36.4 Percentage
RO4998452 5mgPercentage of Participants With at Least One Adverse Event46.2 Percentage
RO4998452 10mgPercentage of Participants With at Least One Adverse Event37.9 Percentage
RO4998452 20mgPercentage of Participants With at Least One Adverse Event35.9 Percentage
RO4998452 40mgPercentage of Participants With at Least One Adverse Event46.3 Percentage

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026