Diabetes Mellitus, Type 2Phase 4NCT00240422
Trial to Compare the Effects of Either Telmisartan (40-80 mg PO Once Daily) or Ramipril (5-10 mg PO Once Daily) on Renal Endothelial Dysfunction in Hypertensive Patients With Type 2 Diabetes
A Phase 4 study testing Telmisartan and Ramipril in people with Diabetes Mellitus, Type 2 and Hypertension, run by Boehringer Ingelheim at 6 sites in 3 countries.
Trial summary
The primary objective is to evaluate the effect of 9 weeks treatment with either telmisartan or ramipril on NO bioavailability in the renal vasculature, measured as renal plasma flow (RPF) in response to NG-monomethyl-L-arginine (LNMMA) infusion. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- Telmisartan and Ramipril
- How many people
- 96 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Feb 2003to Jul 2004
- Phase
- Phase 4
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertensive patients aged 30-80 years with type 2 diabetes, normo- or microalbuminuria, GFR > 80 mL/min (Cockroft-Gault)
Who cannot join
None listed.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany3 sites
Friedrich-Alexander-Universität
Erlangen, 91054
Boehringer Ingelheim Investigational Site
Nuremberg, 90402
Universität Erlangen-Nürnberg
Nuremberg, 90471
France2 sites
Boehringer Ingelheim Investigational Site
Lyon
Boehringer Ingelheim Investigational Site
Montpellier
About this study
Official title: A Prospective, Randomized, Double-blind, Double-dummy, Forced Titration, Parallel Group Comparison, Multicenter Trial to Compare the Effects of Either Telmisartan (40-80 mg p.o. Once Daily) or Ramipril (5-10 mg p.o. Once Daily) on Renal Endothelial Dysfunction in Hypertensive Patients With Type 2 Diabetes
The primary objective is to evaluate the effect of 9 weeks treatment with either telmisartan or ramipril on NO bioavailability in the renal vasculature, measured as renal plasma flow (RPF) in response to NG-monomethyl-L-arginine (LNMMA) infusion.
Read the detailed description
This study was designed as a randomised, double-blind, double-dummy, parallel group in hypertensive patients with type 2 diabetes and normo- or microalbuminuria over a treatment period of 9 weeks.
After a 4 week Run-in period, patients will be randomised to one of the treatment groups and receive either Telmisartan 40 - 80 mg or Ramipril 5 - 10 mg. The treatment regimen is a forced titration with the lower dose given for 3 weeks and the higher dose given for the rest of the treatment period summing up to 9 weeks of treatment. During the treatment period, 3 visits to the investigator will be scheduled in order to control blood pressure, renal function parameters and safety. In addition, parameters of endothelial function in the renal vasculature, based on a nephrological clearance investigation and a provocation with L-NMMA will be measured at baseline and after 9 weeks of treatment.
Study Hypothesis:
Due to the exploratory nature of the trial, the primary objective to evaluate the effect on RPF in response to L-NMMA infusion at baseline and after 9 weeks of therapy with either telmisartan 80 mg or ramipril 10 mg was not planned to be addressed by a test of prespecified hypotheses.
Comparison(s):
The change in RPF from baseline (Visit 4) to the end of treatment (Visit 7) in response to L-NMMA infusion was to be calculated as the change from the pre L-NMMA infusion (S1) to the end of the L-NMMA infusion (S2). A comparison of treatment groups was to be made using an analysis of covariance (ANCOVA) with pooled centre and treatment included as main effects and RPF (in response to L NMMA infusion) at baseline as a covariate. The treatment group difference, adjusted for the other factors in the model, was to be presented with a corresponding 95% confidence interval (CI) and a test of statistical significance. The model was also to be used to provide analysis results for the within treatment group changes.
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Being tested
- Telmisartan, Ramipril
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
RamiprilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of renal plasma flow (RPF) in response to L-NMMA infusion at the end of treatment.
Measured: 9 weeks
Secondary outcomes (27)
Change from baseline of glomerular filtration rate (GFR) in response to L-NMMA infusion at the end of treatment
Measured: 9 weeks
Change from baseline of filtration fraction (FF) in response to L-NMMA infusion at the end of treatment.
Measured: 9 weeks
Change from baseline of renal vascular resistance (RVR) in response to L-NMMA infusion at the end of treatment.
Measured: 9 weeks
Change from baseline of RPF in response to L-arginine infusion at the end of treatment.
Measured: 9 weeks
Change from baseline of GFR in response to L-arginine infusion at the end of treatment
Measured: 9 weeks
Change from baseline of FF in response to L-arginine infusion at the end of treatment.
Measured: 9 weeks
Change from baseline of RVR in response to L-arginine infusion at the end of treatment.
Measured: 9 weeks
Change from baseline of mean arterial pressure (MAP) and pulse rate (PR) in response to L-NMMA infusion at the end of treatment.
Measured: 9 weeks
Change from baseline of MAP and PR in response to L-arginine infusion at the end of treatment.
Measured: 9 weeks
Change from baseline of the laboratory parameters angiotensin II (ANG II), aldosterone, asymmetrical dimethylarginine (ADMA), L-arginine, urinary nitrate/nitrite (UNOx), and urinary albumin excretion at the end of treatment
Measured: 9 weeks
Change from baseline of the pre-L-NMMA RPF at the end of treatment
Measured: 9 weeks
Change from baseline of the pre-L-NMMA GFR at the end of treatment
Measured: 9 weeks
Change from baseline of the pre-L-NMMA FF at the end of treatment.
Measured: 9 weeks
Change from baseline of the pre-L-NMMA RVR at the end of treatment.
Measured: 9 weeks
Change from baseline of the urinary excretion parameters creatinine, sodium, potassium, and urea at the end of treatment.
Measured: 9 weeks
Blood pressure response and control at the end of treatment
Measured: 9 weeks
Change from baseline of central blood pressure and augmentation index (by pulse wave analysis) at the end of treatment.
Measured: 9 weeks
Change from baseline of RPF in response to Vitamin C infusion at the end of treatment
Measured: 9 weeks
Change from baseline of GFR in response to Vitamin C infusion at the end of treatment
Measured: 9 weeks
Change from baseline of FF in response to Vitamin C infusion at the end of treatment.
Measured: 9 weeks
Change from baseline of RVR in response to Vitamin C infusion at the end of treatment.
Measured: 9 weeks
Change from baseline of MAP and PR in response to Vitamin C infusion at the end of treatment.
Measured: 9 weeks
Incidence of adverse events
Measured: week -2 and 9 weeks
Changes from base line in routine laboratory data at the end of the study
Measured: 9 weeks
Changes in vital signs
Measured: 9 weeks
Changes from screening in physical examination at the end of the study
Measured: - 4 weeks and 9 weeks
Changes from screening in ECG at the end of the study
Measured: - 4 weeks and 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startFeb 2003
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. Pharma GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240422
- Sponsor's protocol ID
- 502.398
- Status last verified
- Nov 2013
- First submitted
- 14 Oct 2005
- Last updated
- 8 Nov 2013
- Results posted
- No
Publications
Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.
PubMed 38682786
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Double-dummy, Forced Titration, Parallel Group Comparison, Multicenter Trial to Compare the Effects of Either Telmisartan (40-80 mg p.o. Once Daily) or Ramipril (5-10 mg p.o. Once Daily) on Renal Endothelial Dysfunction in Hypertensive Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00240422
- Acronym / sponsor ID
- 502.398
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Study completion
- Jul 2004
- First posted
- 18 Oct 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.
The primary objective is to evaluate the effect of 9 weeks treatment with either telmisartan or ramipril on NO bioavailability in the renal vasculature, measured as renal plasma flow (RPF) in response to NG-monomethyl-L-arginine (LNMMA) infusion.
Detailed description
This study was designed as a randomised, double-blind, double-dummy, parallel group in hypertensive patients with type 2 diabetes and normo- or microalbuminuria over a treatment period of 9 weeks.
After a 4 week Run-in period, patients will be randomised to one of the treatment groups and receive either Telmisartan 40 - 80 mg or Ramipril 5 - 10 mg. The treatment regimen is a forced titration with the lower dose given for 3 weeks and the higher dose given for the rest of the treatment period summing up to 9 weeks of treatment. During the treatment period, 3 visits to the investigator will be scheduled in order to control blood pressure, renal function parameters and safety. In addition, parameters of endothelial function in the renal vasculature, based on a nephrological clearance investigation and a provocation with L-NMMA will be measured at baseline and after 9 weeks of treatment.
Study Hypothesis:
Due to the exploratory nature of the trial, the primary objective to evaluate the effect on RPF in response to L-NMMA infusion at baseline and after 9 weeks of therapy with either telmisartan 80 mg or ramipril 10 mg was not planned to be addressed by a test of prespecified hypotheses.
Comparison(s):
The change in RPF from baseline (Visit 4) to the end of treatment (Visit 7) in response to L-NMMA infusion was to be calculated as the change from the pre L-NMMA infusion (S1) to the end of the L-NMMA infusion (S2). A comparison of treatment groups was to be made using an analysis of covariance (ANCOVA) with pooled centre and treatment included as main effects and RPF (in response to L NMMA infusion) at baseline as a covariate. The treatment group difference, adjusted for the other factors in the model, was to be presented with a corresponding 95% confidence interval (CI) and a test of statistical significance. The model was also to be used to provide analysis results for the within treatment group changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hypertensive patients aged 30-80 years with type 2 diabetes, normo- or microalbuminuria, GFR > 80 mL/min (Cockroft-Gault)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Telmisartan | Drug | – |
| Ramipril | Drug | – |
Primary outcome
Change from baseline of renal plasma flow (RPF) in response to L-NMMA infusion at the end of treatment.
Time frame: 9 weeks
27 secondary outcomes
Change from baseline of glomerular filtration rate (GFR) in response to L-NMMA infusion at the end of treatment
Time frame: 9 weeks
Change from baseline of filtration fraction (FF) in response to L-NMMA infusion at the end of treatment.
Time frame: 9 weeks
Change from baseline of renal vascular resistance (RVR) in response to L-NMMA infusion at the end of treatment.
Time frame: 9 weeks
Change from baseline of RPF in response to L-arginine infusion at the end of treatment.
Time frame: 9 weeks
Change from baseline of GFR in response to L-arginine infusion at the end of treatment
Time frame: 9 weeks
Change from baseline of FF in response to L-arginine infusion at the end of treatment.
Time frame: 9 weeks
Change from baseline of RVR in response to L-arginine infusion at the end of treatment.
Time frame: 9 weeks
Change from baseline of mean arterial pressure (MAP) and pulse rate (PR) in response to L-NMMA infusion at the end of treatment.
Time frame: 9 weeks
Change from baseline of MAP and PR in response to L-arginine infusion at the end of treatment.
Time frame: 9 weeks
Change from baseline of the laboratory parameters angiotensin II (ANG II), aldosterone, asymmetrical dimethylarginine (ADMA), L-arginine, urinary nitrate/nitrite (UNOx), and urinary albumin excretion at the end of treatment
Time frame: 9 weeks
Change from baseline of the pre-L-NMMA RPF at the end of treatment
Time frame: 9 weeks
Change from baseline of the pre-L-NMMA GFR at the end of treatment
Time frame: 9 weeks
Change from baseline of the pre-L-NMMA FF at the end of treatment.
Time frame: 9 weeks
Change from baseline of the pre-L-NMMA RVR at the end of treatment.
Time frame: 9 weeks
Change from baseline of the urinary excretion parameters creatinine, sodium, potassium, and urea at the end of treatment.
Time frame: 9 weeks
Blood pressure response and control at the end of treatment
Time frame: 9 weeks
Change from baseline of central blood pressure and augmentation index (by pulse wave analysis) at the end of treatment.
Time frame: 9 weeks
Change from baseline of RPF in response to Vitamin C infusion at the end of treatment
Time frame: 9 weeks
Change from baseline of GFR in response to Vitamin C infusion at the end of treatment
Time frame: 9 weeks
Change from baseline of FF in response to Vitamin C infusion at the end of treatment.
Time frame: 9 weeks
Change from baseline of RVR in response to Vitamin C infusion at the end of treatment.
Time frame: 9 weeks
Change from baseline of MAP and PR in response to Vitamin C infusion at the end of treatment.
Time frame: 9 weeks
Incidence of adverse events
Time frame: week -2 and 9 weeks
Changes from base line in routine laboratory data at the end of the study
Time frame: 9 weeks
Changes in vital signs
Time frame: 9 weeks
Changes from screening in physical examination at the end of the study
Time frame: - 4 weeks and 9 weeks
Changes from screening in ECG at the end of the study
Time frame: - 4 weeks and 9 weeks
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 8 Nov 2013.
- Derived from this study: PubMed 38682786Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.
- Related InfoLink provided by the sponsor.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Boehringer Ingelheim Study Coordinator study chair
B.I. Pharma GmbH & Co. KG
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telmisartan and Ramipril in people with Diabetes Mellitus, Type 2 and Hypertension, run by Boehringer Ingelheim at 6 sites in 3 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 1 inclusion and 0 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 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, France, Spain. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change from baseline of renal plasma flow (RPF) in response to L-NMMA infusion at the end of treatment. (time frame: 9 weeks). 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 NCT00240422, which also lists 1 linked publication.
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 8 Nov 2013.