HypertensionPhase 3NCT00274118
DETAIL Study: Diabetes Exposed to Telmisartan and Enalapril
A Phase 3 study testing telmisartan and enalapril in people with Hypertension and Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 37 sites in 6 countries.
Trial summary
To compare the renal consequences of two different approaches to blocking the renin angiotensin system in subjects with hypertension and concurrent Type II diabetes mellitus and diabetic nephropathy. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Type 2
- What is being tested?
- telmisartan and enalapril
- How many people
- 250 participants
- Where
- 37 sitesin 6 countries
- Study dates
- Jul 1997to Jan 2004
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects between the ages 35 and 80 years.
- Current ACE inhibitor therapy for a minimum period of 3 months prior to study entry.
- Confirmed diagnosis of type II diabetes:
- Subjects currently treated by diet or diet and oral hypoglycaemic drugs, OR
- Subjects currently treated with insulin, with a history of onset of diabetes after the age of 40 and a body weight in excess of ideal body weight at the time of diagnosis, and treated with oral agents for a minimum period of two years
- On treatment diastolic blood pressure of < 95 mmHg.
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- Documentation of a normal renal ultrasound within previous 6 months prior to inclusion (alternate methods eg pyelography, renal isotope method was also acceptable).
- Mean of three consecutive overnight urinary albumin excretion rates > 20 and < 1000 g/min at the end of the pre-treatment observation period. (A minimum of two of the three samples must be > 20 g/min.)
- Glycosylated haemoglobin (HbA 1c) < 10%.
- Serum creatinine < 140 mol/L.
- Glomerular filtration rate (GFR) > 70 ml/min/1.73 m2.
- Ability to provide written informed consent.
Who cannot join
- Type I diabetes mellitus.
- Pre-menopausal women (last menstruation < 1 year prior to start of screening period):
- Who were not surgically sterile (tubal ligation, hysterectomy) or
- Who were not practising acceptable means of birth control (and do not plan to continue using this method throughout the study). Acceptable methods of birth control include oral, implantable or injectable contraceptives.
- Who had a positive serum pregnancy test at baseline.
- Afro-Caribbean subjects.
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- Mean seated SBP > 180 mmHg.
- Hepatic dysfunction as defined by the following laboratory parameters: SGPT(ALT) or SGOT(AST) > 1.5 times the upper limit of normal.
- Known causes of renal dysfunction other than diabetic nephropathy.
- Subjects who had a solitary kidney or known renal artery stenosis.
- NYHA functional class CHF II - IV.
- Known drug or alcohol dependency.
- Subjects receiving any investigational therapy within one month of providing written informed consent.
- Known hypersensitivity to telmisartan or ACE inhibitors or to any component of the formulation.
- Subjects with a history of suspected angioedema related to ACE inhibitor therapy.
Trial locations and contacts
37 sites in 6 countries.
37 sites in 6 countries
United Kingdom12 sites
Boehringer Ingelheim Investigational Site
Atherstone, CV9 1EU
Boehringer Ingelheim Investigational Site
Barry, CF62 7EB
Dept. of Diabetes
Birmingham, B18 7QH
Department of Respiratory Medicine
Birmingham, B9 5SS
Royal Bournemouth Hospital
Bournemouth, BH7 7DW
Finance Office (Research Unit)
Newcastle upon Tyne, NE1 7RU
Northampton General Hospital
Northampton, NN1 5BD
Boehringer Ingelheim Investigational Site
Northampton, NN5 7AQ
Diabetes Centre,
Nuneaton, CV10 7DJ
Lucille Packard Children's Health Services at Stanford
Palo Alto, 94304-5786
Boehringer Ingelheim Investigational Site
Pont-y-clun, CF72 9AA
Diabetes Centre
Rugby, CV22 5PX
Sweden8 sites
Medicinkliniken
Eksjö, 575 81
Medicinkliniken
Helsingborg, 251 87
Boehringer Ingelheim Investigational Site
Helsingborg, 254 67
Boehringer Ingelheim Investigational Site
Munkedal, 455 30
Boehringer Ingelheim Investigational Site
Tranås, 573 83
Boehringer Ingelheim Investigational Site
Uddevalla, 451 40
Samariterhemmets sjukhus
Uppsala, 751 25
Boehringer Ingelheim Investigational Site
Vetlanda, 574 28
Denmark6 sites
Apopleksiafsnittet
Frederiksberg, DK-2000
Boehringer Ingelheim Investigational Site
Frederiksberg C, DK-1900
Lungemedicinsk Forskning
Hellerup, DK-2900
Medical Dept. B0642
Hillerød, DK-3400
Hvidovre Hospital
Hvidovre, DK-2650
Gynækologisk/obstetrisk afd.
Kolding, 6000
Finland5 sites
Boehringer Ingelheim Investigational Site
Hyvinkää, 05850
Boehringer Ingelheim Investigational Site
Jyväskylä, FIN-40100
Kuopion yliopistollinen sairaala, Keuhkoklinikka
Kuopio, FI-70211
Boehringer Ingelheim Investigational Site
Riihimäki, 11100
Boehringer Ingelheim Investigational Site
Tampere, 33520
Norway4 sites
Boehringer Ingelheim Investigational Site
Arendal, N-4841
Boehringer Ingelheim Investigational Site
Jessheim, N-2050
Boehringer Ingelheim Investigational Site
Skogn, N-7620
Hjertelaget Research Foundation
Stavanger, N-4011
Netherlands2 sites
Bosch Medicentrum
's-Hertogenbosch, 5223 GV
Dept. of Internal Medicine
Utrecht, 3584 CX
About this study
Official title: DETAIL = Diabetics Exposed to Telmisartan And enalapIL: A Randomised, Double-blind, Parallel-group Comparison of the Renal and Antihypertensive Effects of Telmisartan and Enalapril in Subjects With Mild to Moderate Hypertension and Concurrent Type II Diabetes Mellitus and Diabetic Nephropathy
To compare the renal consequences of two different approaches to blocking the renin angiotensin system in subjects with hypertension and concurrent Type II diabetes mellitus and diabetic nephropathy.
Read the detailed description
The aims of this study were to compare the renal consequences of two different approaches to blocking the activity of the renin angiotensin system - Angiotensin II antagonism with telmisartan and ACE inhibition with enalapril - in patients with hypertension and concurrent type II diabetes mellitus and diabetic nephropathy.
The study was designed to investigate albumin excretion rates in the short term, and in the longer term, to assess the outcome with respect to maintenance of renal function (GFR) and incidence of clinical endpoints.
Study Hypothesis:
Association of Hypertension and Diabetes Essential hypertension accounts for the majority of hypertension in people with diabetes, particularly in those with type II diabetes, who constitute more than 90% of those with a dual diagnosis of diabetes and hypertension.
Both diabetes and hypertension each confer increased cardiovascular risk, and patients with both conditions have more atherogenic risk factors.
Albumin Excretion as a Therapeutic Marker Microalbuminuria is an early and reliable predictor of diabetic nephropathy in both type I - insulin dependent diabetes mellitus (IDDM) and type II - non insulin dependent diabetes mellitus (NIDDM) patients, nephropathy being characterised by hypertension and an inevitable decline in renal function.
Furthermore, diabetic nephropathy is the single most important cause of end stage renal failure (ESRF) in the western world and over recent years the incidence of ESRF in patients with type II diabetes has dramatically increased.
In addition to predicting nephropathy, in type II diabetes, microalbuminuria also predicts mortality, the major causes of death being related to cardiovascular disease.
Comparison(s):
Selection of an ACE Inhibitor as the Comparative Agent Findings in preclinical studies of animals with diabetes mellitus suggest that ACE inhibitors reduce glomerular damage by one or more mechanisms independent of their antihypertensive effects. Glomerular efferent arteriolar tone is increased in diabetic animals and as a result there is an increase in transcapillary hydraulic pressure. These alterations may decrease the functional integrity of the glomerular capillary wall. In rats with diabetes, the long term administration of an ACE inhibitor diminishes the functional and morphologic evidence of glomerular injury and decreases glomerular transcapillary pressure. Removal of the tonic constrictor effect of angiotensin II on efferent arterioles would be expected to lower glomerular intracapillary pressure while preserving renal plasma flow.
Angiotensin II antagonists appear to be as effective as ACE inhibitors in delaying the progression of renal injury in animal models of diabetes.
- Conditions
- Hypertension, Diabetes Mellitus, Type 2
- Being tested
- telmisartan, enalapril
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telmisartanDrug
enalaprilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in glomerular filtration rate GFR after five years of treatment.
Measured: 5 years
Secondary outcomes (10)
Change from baseline in GFR after one, two, three and four years of treatment
Measured: Baseline, 1,2,3 and 4 years
Percentage change from baseline in urinary albumin excretion rate
Measured: up to 5 years
Change from baseline in creatinine
Measured: up to 5 years
Incidence of clinical endpoints (including- end-stage renal disease, myocardial infarction, cerebrovascular accident, congestive heart failure)
Measured: up to 5 years
Incidence of all cause mortality
Measured: up to 5 years
Changes in vital signs (DBP, SBP, pulse rate)
Measured: up to 5 years
Number of patients with Adverse Events
Measured: up to 5 years
Physical examination
Measured: up to 5 years
Clinical laboratory parameters
Measured: up to 5 years
Resting 12-lead ECG
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startJul 1997
- Primary completionJan 2004
- Study completionJan 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 HypertensionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim Ltd./Bracknell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274118
- Sponsor's protocol ID
- 502.236
- Status last verified
- Oct 2013
- First submitted
- 9 Jan 2006
- Last updated
- 1 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 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DETAIL = Diabetics Exposed to Telmisartan And enalapIL: A Randomised, Double-blind, Parallel-group Comparison of the Renal and Antihypertensive Effects of Telmisartan and Enalapril in Subjects With Mild to Moderate Hypertension and Concurrent Type II Diabetes Mellitus and Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT00274118
- Acronym / sponsor ID
- 502.236
- Conditions
- Hypertension, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 1997
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004
- First posted
- 10 Jan 2006 (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.
To compare the renal consequences of two different approaches to blocking the renin angiotensin system in subjects with hypertension and concurrent Type II diabetes mellitus and diabetic nephropathy.
Detailed description
The aims of this study were to compare the renal consequences of two different approaches to blocking the activity of the renin angiotensin system - Angiotensin II antagonism with telmisartan and ACE inhibition with enalapril - in patients with hypertension and concurrent type II diabetes mellitus and diabetic nephropathy.
The study was designed to investigate albumin excretion rates in the short term, and in the longer term, to assess the outcome with respect to maintenance of renal function (GFR) and incidence of clinical endpoints.
Study Hypothesis:
Association of Hypertension and Diabetes Essential hypertension accounts for the majority of hypertension in people with diabetes, particularly in those with type II diabetes, who constitute more than 90% of those with a dual diagnosis of diabetes and hypertension.
Both diabetes and hypertension each confer increased cardiovascular risk, and patients with both conditions have more atherogenic risk factors.
Albumin Excretion as a Therapeutic Marker Microalbuminuria is an early and reliable predictor of diabetic nephropathy in both type I - insulin dependent diabetes mellitus (IDDM) and type II - non insulin dependent diabetes mellitus (NIDDM) patients, nephropathy being characterised by hypertension and an inevitable decline in renal function.
Furthermore, diabetic nephropathy is the single most important cause of end stage renal failure (ESRF) in the western world and over recent years the incidence of ESRF in patients with type II diabetes has dramatically increased.
In addition to predicting nephropathy, in type II diabetes, microalbuminuria also predicts mortality, the major causes of death being related to cardiovascular disease.
Comparison(s):
Selection of an ACE Inhibitor as the Comparative Agent Findings in preclinical studies of animals with diabetes mellitus suggest that ACE inhibitors reduce glomerular damage by one or more mechanisms independent of their antihypertensive effects. Glomerular efferent arteriolar tone is increased in diabetic animals and as a result there is an increase in transcapillary hydraulic pressure. These alterations may decrease the functional integrity of the glomerular capillary wall. In rats with diabetes, the long term administration of an ACE inhibitor diminishes the functional and morphologic evidence of glomerular injury and decreases glomerular transcapillary pressure. Removal of the tonic constrictor effect of angiotensin II on efferent arterioles would be expected to lower glomerular intracapillary pressure while preserving renal plasma flow.
Angiotensin II antagonists appear to be as effective as ACE inhibitors in delaying the progression of renal injury in animal models of diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female subjects between the ages 35 and 80 years.
- Current ACE inhibitor therapy for a minimum period of 3 months prior to study entry.
- Confirmed diagnosis of type II diabetes:
- On treatment diastolic blood pressure of < 95 mmHg.
- Documentation of a normal renal ultrasound within previous 6 months prior to inclusion (alternate methods eg pyelography, renal isotope method was also acceptable).
Key exclusion criteria (15 listed)
- Type I diabetes mellitus.
- Pre-menopausal women (last menstruation < 1 year prior to start of screening period):
- Afro-Caribbean subjects.
- Mean seated SBP > 180 mmHg.
- Hepatic dysfunction as defined by the following laboratory parameters: SGPT(ALT) or SGOT(AST) > 1.5 times the upper limit of normal.
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 | – |
| enalapril | Drug | – |
Primary outcome
Change from baseline in glomerular filtration rate GFR after five years of treatment.
Time frame: 5 years
10 secondary outcomes
Change from baseline in GFR after one, two, three and four years of treatment
Time frame: Baseline, 1,2,3 and 4 years
Percentage change from baseline in urinary albumin excretion rate
Time frame: up to 5 years
Change from baseline in creatinine
Time frame: up to 5 years
Incidence of clinical endpoints (including- end-stage renal disease, myocardial infarction, cerebrovascular accident, congestive heart failure)
Time frame: up to 5 years
Incidence of all cause mortality
Time frame: up to 5 years
Changes in vital signs (DBP, SBP, pulse rate)
Time frame: up to 5 years
Number of patients with Adverse Events
Time frame: up to 5 years
Physical examination
Time frame: up to 5 years
Clinical laboratory parameters
Time frame: up to 5 years
Resting 12-lead ECG
Time frame: up to 5 years
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 1 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 InfoLink provided by the sponsor.
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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.
Boehringer Ingelheim Study Coordinator study chair
Boehringer Ingelheim Ltd./Bracknell
37 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing telmisartan and enalapril in people with Hypertension and Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 37 sites in 6 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 12 inclusion and 15 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 1 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 37 sites in United Kingdom, Sweden, Denmark, Finland, Norway and 1 more country. 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 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?
Change from baseline in glomerular filtration rate GFR after five years of treatment. (time frame: 5 years). 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 NCT00274118, 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 1 Nov 2013.