DETAIL Study: Diabetes Exposed to Telmisartan and Enalapril

NCT00274118 | Completed Phase 3

• 1 other identifier: 502.236
• Study Type: interventional
• Target: 250
• Locations: 6 countries
• Sites: 37

Brief 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.

Conditions

Hypertension; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change from baseline in glomerular filtration rate GFR after five years of treatment.

  5 years

Secondary Outcomes (10)

• Change from baseline in GFR after one, two, three and four years of treatment

  Baseline, 1,2,3 and 4 years

• Percentage change from baseline in urinary albumin excretion rate

  up to 5 years

• Change from baseline in creatinine

  up to 5 years

• Incidence of clinical endpoints (including- end-stage renal disease, myocardial infarction, cerebrovascular accident, congestive heart failure)

  up to 5 years

• Incidence of all cause mortality

  up to 5 years

Interventions

telmisartan DRUG

enalapril DRUG

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (37)

Apopleksiafsnittet

Frederiksberg, DK-2000, Denmark

Location

Boehringer Ingelheim Investigational Site

Frederiksberg C, DK-1900, Denmark

Location

Lungemedicinsk Forskning

Hellerup, DK-2900, Denmark

Location

Medical Dept. B0642

Hillerød, DK-3400, Denmark

Location

Hvidovre Hospital

Hvidovre, DK-2650, Denmark

Location

Gynækologisk/obstetrisk afd.

Kolding, 6000, Denmark

Location

Boehringer Ingelheim Investigational Site

Hyvinkää, 05850, Finland

Location

Boehringer Ingelheim Investigational Site

Jyväskylä, FIN-40100, Finland

Location

Kuopion yliopistollinen sairaala, Keuhkoklinikka

Kuopio, FI-70211, Finland

Location

Boehringer Ingelheim Investigational Site

Riihimäki, 11100, Finland

Location

Boehringer Ingelheim Investigational Site

Tampere, 33520, Finland

Location

Bosch Medicentrum

's-Hertogenbosch, 5223 GV, Netherlands

Location

Dept. of Internal Medicine

Utrecht, 3584 CX, Netherlands

Location

Boehringer Ingelheim Investigational Site

Arendal, N-4841, Norway

Location

Boehringer Ingelheim Investigational Site

Jessheim, N-2050, Norway

Location

Boehringer Ingelheim Investigational Site

Skogn, N-7620, Norway

Location

Hjertelaget Research Foundation

Stavanger, N-4011, Norway

Location

Medicinkliniken

Eksjö, 575 81, Sweden

Location

Medicinkliniken

Helsingborg, 251 87, Sweden

Location

Boehringer Ingelheim Investigational Site

Helsingborg, 254 67, Sweden

Location

Boehringer Ingelheim Investigational Site

Munkedal, 455 30, Sweden

Location

Boehringer Ingelheim Investigational Site

Tranås, 573 83, Sweden

Location

Boehringer Ingelheim Investigational Site

Uddevalla, 451 40, Sweden

Location

Samariterhemmets sjukhus

Uppsala, 751 25, Sweden

Location

Boehringer Ingelheim Investigational Site

Vetlanda, 574 28, Sweden

Location

Boehringer Ingelheim Investigational Site

Atherstone, CV9 1EU, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Barry, CF62 7EB, United Kingdom

Location

Dept. of Diabetes

Birmingham, B18 7QH, United Kingdom

Location

Department of Respiratory Medicine

Birmingham, B9 5SS, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Finance Office (Research Unit)

Newcastle upon Tyne, NE1 7RU, United Kingdom

Location

Northampton General Hospital

Northampton, NN1 5BD, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Northampton, NN5 7AQ, United Kingdom

Location

Diabetes Centre,

Nuneaton, CV10 7DJ, United Kingdom

Location

Lucille Packard Children's Health Services at Stanford

Palo Alto, 94304-5786, United Kingdom

Location

Boehringer Ingelheim Investigational Site

Pont-y-clun, CF72 9AA, United Kingdom

Location

Diabetes Centre

Rugby, CV22 5PX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38682786 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Interventions

Telmisartan; Enalapril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Boehringer Ingelheim Study Coordinator

  Boehringer Ingelheim Ltd./Bracknell

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 9, 2006
• First Posted: January 10, 2006
• Study Start: July 1, 1997
• Primary Completion: January 1, 2004
• Study Completion: January 1, 2004
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

GB (12); NO (4); NL (2); SE (8); FI (5); DK (6)