Diabetes Mellitus, Type 2Phase 3NCT00185159
Olmesartan Medoxomil in Diabetes Mellitus
A Phase 3 study testing Olmesartan medoxomil in people with Diabetes Mellitus, Type 2 and Cardiovascular Disease, run by Sankyo Pharma Gmbh at 1 site in Germany.
Trial summary
This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cardiovascular Disease, Kidney Disease
- What is being tested?
- Olmesartan medoxomil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,449 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2004to Jul 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Diabetes mellitus type 2, defined as fasting blood glucose of greater than or equal to 126 mg/dL;
- Presence of at least one of the following cardiovascular risk factors:
- total cholesterol greater than 200 mg/dL or statin treatment,
- High density lipoprotein (HDL) less than 40 mg/dL,
- triglycerides greater than 150 mg/dL and less than 400 mg/dL,
- blood pressure greater than or equal to 130/80 mmHg,
Show all 10Show fewer
- Body mass index (BMI) greater than 28 kg/m2,
- waist circumference greater than 102 cm for men and greater than 88 cm for women,
- smoking of more than 5 cigarettes a day;
- Normoalbuminuria at screening
Who cannot join
- Severe uncontrolled hyperlipidemia;
- Documented renal and/or renal-vascular disease;
- Myocardial infarction, stroke or myocardial revascularization within the last 6 months;
- History of alcohol and/or drug abuse;
- Allergic reaction, lack of response or contraindication to angiotensin receptor blockers (ARBs);
- Current treatment with an ARB or angiotensin converting enzyme (ACE) inhibitor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)
This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.
- Being tested
- Olmesartan medoxomil, Placebo Tablets
- Keywords
- Microalbuminuria
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olmesartan medoxomilDrug
tablets
Placebo TabletsDrug
Tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | olmesartan medoxomil Receives: Drug: Olmesartan medoxomil |
| 2 | Placebo comparator | placebo Receives: Drug: Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine
Measured: Time to the first occurrence
Secondary outcomes (5)
Incidence of cardiovascular mortality and morbidity
Measured: Time to occurence
Incidence of renal disease, such as worsening of renal function as well as end-stage (dialysis)
Measured: Time to occurrence
Occurrence and progression of retinopathy
Measured: Time to occurence
Treatment effects on a combined endpoint of cardiovascular mortality and morbidity and renal disease
Measured: Time to occurrence
Safety and tolerability
Measured: Throughout entire study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4,449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sankyo Pharma Gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Prof. Hermann Haller, MD, Principal investigator, Medizinische Hochschule Hannover Klinik fur Nieren, Hannover Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185159
- Sponsor's protocol ID
- SE-866/44
- Status last verified
- Jan 2010
- First submitted
- 12 Sep 2005
- Last updated
- 20 Jan 2010
- Results posted
- No
Publications
Do DV, Han G, Abariga SA, Sleilati G, Vedula SS, Hawkins BS. Blood pressure control for diabetic retinopathy. Cochrane Database Syst Rev. 2023 Mar 28;3(3):CD006127. doi: 10.1002/14651858.CD006127.pub3.
PubMed 36975019Chatzikyrkou C, Menne J, Izzo J, Viberti G, Rabelink T, Ruilope LM, Rump C, Mertens PR, Haller H. Predictors for the development of microalbuminuria and interaction with renal function. J Hypertens. 2017 Dec;35(12):2501-2509. doi: 10.1097/HJH.0000000000001491.
PubMed 29035939Menne J, Ritz E, Ruilope LM, Chatzikyrkou C, Viberti G, Haller H. The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) observational follow-up study: benefits of RAS blockade with olmesartan treatment are sustained after study discontinuation. J Am Heart Assoc. 2014;3(2):e000810. doi: 10.1161/jaha.114.000810.
PubMed 24772521Menne J, Izzo JL Jr, Ito S, Januszewicz A, Katayama S, Chatzykirkou C, Mimran A, Rabelink TJ, Ritz E, Ruilope LM, Rump LC, Viberti G, Haller H; ROADMAP investigators. Prevention of microalbuminuria in patients with type 2 diabetes and hypertension. J Hypertens. 2012 Apr;30(4):811-8; discussion 818. doi: 10.1097/HJH.0b013e328351856d.
PubMed 22418908Haller H, Ito S, Izzo JL Jr, Januszewicz A, Katayama S, Menne J, Mimran A, Rabelink TJ, Ritz E, Ruilope LM, Rump LC, Viberti G; ROADMAP Trial Investigators. Olmesartan for the delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med. 2011 Mar 10;364(10):907-17. doi: 10.1056/NEJMoa1007994.
PubMed 21388309Januszewicz A, Ritz E, Viberti G, Mimran A, Rabelink AJ, Rump LC, Ruilope LM, Katayama S, Ito S, Izzo JL Jr, Haller H. Office and ambulatory pulse pressure--association with clinical characteristics and cardiovascular risk factors in normoalbuminuric patients with type 2 diabetes (ROADMAP study). J Hum Hypertens. 2011 Nov;25(11):679-85. doi: 10.1038/jhh.2010.111. Epub 2010 Dec 9.
PubMed 21150933Ritz E, Viberti GC, Ruilope LM, Rabelink AJ, Izzo JL Jr, Katayama S, Ito S, Mimran A, Menne J, Rump LC, Januszewicz A, Haller H. Determinants of urinary albumin excretion within the normal range in patients with type 2 diabetes: the Randomised Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study. Diabetologia. 2010 Jan;53(1):49-57. doi: 10.1007/s00125-009-1577-3. Epub 2009 Oct 30.
PubMed 19876613
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)
- ClinicalTrials.gov ID
- NCT00185159
- Acronym / sponsor ID
- SE-866/44
- Keywords
- Microalbuminuria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,449 participants (actual)
- Lead sponsor
- Sankyo Pharma GmbhIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Olmesartan medoxomilolmesartan medoxomil |
| 2 | Placebo comparator | Drug: Placebo Tabletsplacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diabetes mellitus type 2, defined as fasting blood glucose of greater than or equal to 126 mg/dL;
- Presence of at least one of the following cardiovascular risk factors:
- Normoalbuminuria at screening
Key exclusion criteria (6 listed)
- Severe uncontrolled hyperlipidemia;
- Documented renal and/or renal-vascular disease;
- Myocardial infarction, stroke or myocardial revascularization within the last 6 months;
- History of alcohol and/or drug abuse;
- Allergic reaction, lack of response or contraindication to angiotensin receptor blockers (ARBs);
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 |
|---|---|---|
| Olmesartan medoxomiltablets | Drug | 1 |
| Placebo TabletsTablets | Drug | 2 |
Primary outcome
Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine
Time frame: Time to the first occurrence
5 secondary outcomes
Incidence of cardiovascular mortality and morbidity
Time frame: Time to occurence
Incidence of renal disease, such as worsening of renal function as well as end-stage (dialysis)
Time frame: Time to occurrence
Occurrence and progression of retinopathy
Time frame: Time to occurence
Treatment effects on a combined endpoint of cardiovascular mortality and morbidity and renal disease
Time frame: Time to occurrence
Safety and tolerability
Time frame: Throughout entire study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
- Derived from this study: PubMed 36975019Do DV, Han G, Abariga SA, Sleilati G, Vedula SS, Hawkins BS. Blood pressure control for diabetic retinopathy. Cochrane Database Syst Rev. 2023 Mar 28;3(3):CD006127. doi: 10.1002/14651858.CD006127.pub3.
- Derived from this study: PubMed 29035939Chatzikyrkou C, Menne J, Izzo J, Viberti G, Rabelink T, Ruilope LM, Rump C, Mertens PR, Haller H. Predictors for the development of microalbuminuria and interaction with renal function. J Hypertens. 2017 Dec;35(12):2501-2509. doi: 10.1097/HJH.0000000000001491.
- Derived from this study: PubMed 24772521Menne J, Ritz E, Ruilope LM, Chatzikyrkou C, Viberti G, Haller H. The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) observational follow-up study: benefits of RAS blockade with olmesartan treatment are sustained after study discontinuation. J Am Heart Assoc. 2014;3(2):e000810. doi: 10.1161/jaha.114.000810.
- Derived from this study: PubMed 22418908Menne J, Izzo JL Jr, Ito S, Januszewicz A, Katayama S, Chatzykirkou C, Mimran A, Rabelink TJ, Ritz E, Ruilope LM, Rump LC, Viberti G, Haller H; ROADMAP investigators. Prevention of microalbuminuria in patients with type 2 diabetes and hypertension. J Hypertens. 2012 Apr;30(4):811-8; discussion 818. doi: 10.1097/HJH.0b013e328351856d.
- Derived from this study: PubMed 21388309Haller H, Ito S, Izzo JL Jr, Januszewicz A, Katayama S, Menne J, Mimran A, Rabelink TJ, Ritz E, Ruilope LM, Rump LC, Viberti G; ROADMAP Trial Investigators. Olmesartan for the delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med. 2011 Mar 10;364(10):907-17. doi: 10.1056/NEJMoa1007994.
- Derived from this study: PubMed 21150933Januszewicz A, Ritz E, Viberti G, Mimran A, Rabelink AJ, Rump LC, Ruilope LM, Katayama S, Ito S, Izzo JL Jr, Haller H. Office and ambulatory pulse pressure--association with clinical characteristics and cardiovascular risk factors in normoalbuminuric patients with type 2 diabetes (ROADMAP study). J Hum Hypertens. 2011 Nov;25(11):679-85. doi: 10.1038/jhh.2010.111. Epub 2010 Dec 9.
- Derived from this study: PubMed 19876613Ritz E, Viberti GC, Ruilope LM, Rabelink AJ, Izzo JL Jr, Katayama S, Ito S, Mimran A, Menne J, Rump LC, Januszewicz A, Haller H. Determinants of urinary albumin excretion within the normal range in patients with type 2 diabetes: the Randomised Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study. Diabetologia. 2010 Jan;53(1):49-57. doi: 10.1007/s00125-009-1577-3. Epub 2009 Oct 30.
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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.
Prof. Hermann Haller, MD principal investigator
Medizinische Hochschule Hannover Klinik fur Nieren, Hannover Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olmesartan medoxomil in people with Diabetes Mellitus, Type 2 and Cardiovascular Disease, run by Sankyo Pharma Gmbh at 1 site in Germany.
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 10 inclusion and 6 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 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine (time frame: Time to the first occurrence). 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 NCT00185159, which also lists 7 linked publications.
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 20 Jan 2010.