Diabetes Mellitus Type 2Phase 2NCT00800176

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

A Phase 2 study testing RO4998452 in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 67 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes Mellitus Type 2
What is being tested?: RO4998452
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 394 participants
Where: 67 sitesin 12 countries
Study dates: 22 Jan 2009to 28 Oct 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

67 sites in 12 countries.

Country

City, postcode or hospital

67 sites in 12 countries

Russia12 sites

Study site
Moscow, 117049
Study site
Moscow, 119121
Study site
Moscow, 129110
Study site
Nizhny Novgorod, 603126
Study site
Novosibirsk, 630047
Study site
S.petersburg, 194017
Study site
Saint Petersburg, 191124
Study site
Saint Petersburg, 195257
Study site
Saint Petersburg, 197089
Study site
Saint Petersburg, 197198
Study site
Saratov, 410038
Study site
Yaroslavl, 150062

Other trials in Russia

United States11 sites

Study site
Atlanta, Georgia, 30342
Study site
Bradenton, Florida, 34208
Study site
Greensboro, North Carolina, 27408
Study site
Hayden Lake, Idaho, 83835
Study site
Jacksonville, Florida, 32216
Study site
Los Angeles, California, 90057
Study site
Midland, Texas, 79707
Study site
Palm Springs, California, 92262
Study site
Phoenix, Arizona, 85015
Study site
Richmond, Virginia, 23294
Study site
Rochester, New York, 14609

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Japan8 sites

Study site
Fukuoka, 812-0025
Study site
Ibaraki, 311-0113
Study site
Kanagawa, 232-0064
Study site
Osaka, 530-0001
Study site
Saitama, 343-0827
Study site
Saitama, 362-0021
Study site
Tokyo, 160-0017
Study site
Tokyo, 192-0071

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Romania7 sites

Study site
Alba Iulia, 51077
Study site
Brasov, 500365
Study site
Bucharest, 020045
Study site
Bucharest, 020475
Study site
Bucharest, 020725
Study site
Bucharest
Study site
Târgu Mureş, 540004

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Canada5 sites

Study site
London, Ontario, NGA 4V2
Study site
Montreal, Quebec, H2W 1T8
Study site
Toronto, Ontario, M4G 3E8
Study site
Toronto, Ontario, M9W 4L6
Study site
Vancouver, British Columbia, V5Z 1L8

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Germany5 sites

Study site
Berlin, 10115
Study site
Falkensee, 14612
Study site
Lübeck, 23562
Study site
Mainz, 55116
Study site
Neuss, 41460

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Brazil4 sites

Study site
Fortaleza, 60120-021
Study site
Goiânia, 74043011
Study site
São Paulo, 01244-030
Study site
São Paulo, 04022-001

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Latvia4 sites

Study site
Jelgava, LV-3001
Study site
Riga, 1002
Study site
Talsi, 3200
Study site
Valmiera, 4201

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Mexico4 sites

Study site
Chihuahua City, 31238
Study site
Guadalajara, 44600
Study site
Guadalajara, 44650
Study site
Mexico City, 11650

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Spain3 sites

Study site
Alzira, 46600
Study site
Lleida, 25198
Study site
Seville, 41013

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Australia2 sites

Study site
Adelaide, 5000
Study site
St Leonards, 2065

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Hong Kong2 sites

Study site
Hong Kong, 852
Study site
Hong Kong

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About this study

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

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

Conditions: Diabetes Mellitus Type 2
Being tested: Placebo, RO4998452
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
po daily for 12 weeks
RO4998452Drug
2.5mg po daily for 12 weeks
RO4998452Drug
5mg po daily for 12 weeks
RO4998452Drug
10mg po daily for 12 weeks
RO4998452Drug
20mg po daily for 12 weeks
RO4998452Drug
40mg po daily for 12 weeks

Study groups in NCT00800176
Study group	Role	What they receive
Placebo	Placebo comparator	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. Receives: Drug: Placebo
RO4998452 10mg	Experimental	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. Receives: Drug: RO4998452
RO4998452 2.5mg	Experimental	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. Receives: Drug: RO4998452
RO4998452 20mg	Experimental	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. Receives: Drug: RO4998452
RO4998452 40mg	Experimental	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. Receives: Drug: RO4998452
RO4998452 5mg	Experimental	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. Receives: Drug: RO4998452

What is being measured

The primary outcome is the main question the study is designed to answer.

Absolute Change in HbA1c
Measured: Baseline, Week 4, Week 8 and Week 12

Secondary outcomes (10)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 200928 Oct 2009

First posted2 Dec 2008 (estimated)
Study start22 Jan 2009
Primary completion28 Oct 2009
Study completion28 Oct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 394 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00800176
Sponsor's protocol ID: BC21587
Other IDs: 2008-001249-24, 2008
Status last verified: Nov 2020
First submitted: 1 Dec 2008
Last updated: 18 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00800176
Acronym / sponsor ID: BC21587
Conditions: Diabetes Mellitus Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 394 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 22 Jan 2009 (actual)
Primary completion: 28 Oct 2009 (actual)
Study completion: 28 Oct 2009 (actual)
First posted: 2 Dec 2008 (estimated)
Results: Posted 18 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboDuring 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 10mg	Experimental	Drug: RO4998452During 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	Experimental	Drug: RO4998452During 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.
RO4998452 20mg	Experimental	Drug: RO4998452During 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 40mg	Experimental	Drug: RO4998452During 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 5mg	Experimental	Drug: RO4998452During 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebopo daily for 12 weeks	Drug	Placebo
RO49984522.5mg po daily for 12 weeks	Drug	RO4998452 2.5mg
RO49984525mg po daily for 12 weeks	Drug	RO4998452 5mg
RO499845210mg po daily for 12 weeks	Drug	RO4998452 10mg
RO499845220mg po daily for 12 weeks	Drug	RO4998452 20mg
RO499845240mg po daily for 12 weeks	Drug	RO4998452 40mg

Primary outcome

Absolute Change in HbA1c
Time frame: Baseline, Week 4, Week 8 and Week 12

10 secondary outcomes

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

Results and safety

Results posted to the registry on 18 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	66	57
RO4998452 2.5mg	66	60
RO4998452 5mg	65	65
RO4998452 10 mg	66	62
RO4998452 20mg	64	60
RO4998452 40mg	67	62

Primary outcome: Absolute Change in HbA1c

Time frame: Baseline, Week 4, Week 8 and Week 12. Mean (95% Confidence Interval). Unit: Percentage

Measure	Placebo n = 65	RO4998452 2.5 mg n = 64	RO4998452 5mg n = 65	RO4998452 10mg n = 66	RO4998452 20mg n = 64	RO4998452 40mg n = 66
Baseline	7.872 (7.695 to 8.049)	7.939 (7.829 to 8.118)	8.006 (7.823 to 8.183)	7.998 (7.823 to 8.174)	7.919 (7.740 to 8.097)	7.933 (7.758 to 8.109)
Week 4	-0.238 (-0.341 to -0.135)	-0.394 (-0.497 to -0.291)	-0.460 (-0.561 to -0.358)	-0.539 (-0.641 to -0.437)	-0.516 (-0.619 to -0.413)	-0.564 (-0.664 to -0.464)
Week 8	-0.280 (-0.405 to -0.155)	-0.468 (-0.594 to -0.342)	-0.611 (-0.736 to -0.486)	-0.694 (-0.840 to -0.549)	-0.768 (-0.916 to -0.620)	-0.832 (-0.976 to -0.688)
Week 12	-0.269 (-0.415 to -0.123)	-0.440 (-0.588 to -0.293)	-0.617 (-0.763 to -0.471)	-0.694 (-0.840 to -0.549)	-0.768 (-0.916 to -0.620)	-0.832 (-0.976 to -0.688)

Population analysed: 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.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 8 months. Other adverse events reported at 0.05% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 66 (1.5%)	25 of 66 (37.9%)	Not reported
RO4998452 2.5mg	2 of 66 (3%)	24 of 66 (36.4%)	Not reported
RO4998452 5mg	0 of 65 (0%)	30 of 65 (46.2%)	Not reported
RO4998452 10mg	0 of 66 (0%)	25 of 66 (37.9%)	Not reported
RO4998452 20mg	0 of 64 (0%)	23 of 64 (35.9%)	Not reported
RO4998452 40mg	1 of 67 (1.5%)	31 of 67 (46.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

67 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RO4998452 in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 67 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in Russia, United States, Japan, Romania, Canada and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change in HbA1c (time frame: Baseline, Week 4, Week 8 and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00800176.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.