DETAIL Study: Diabetes Exposed to Telmisartan and Enalapril

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Enalapril; Enalaprilat; Telmisartan

Criteria

Inclusion Criteria:

1. Male or female subjects between the ages 35 and 80 years.

2. Current ACE inhibitor therapy for a minimum period of 3 months prior to study entry.

3. 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

4. On treatment diastolic blood pressure of < 95 mmHg.

5. Documentation of a normal renal ultrasound within previous 6 months prior to inclusion (alternate methods eg pyelography, renal isotope method was also acceptable).

6. 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.)

7. Glycosylated haemoglobin (HbA 1c) < 10%.

8. Serum creatinine < 140 mol/L.

9. Glomerular filtration rate (GFR) > 70 ml/min/1.73 m2.

10. Ability to provide written informed consent.

Exclusion Criteria:

1. Type I diabetes mellitus.

2. 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.

3. Afro-Caribbean subjects.

4. Mean seated SBP > 180 mmHg.

5. Hepatic dysfunction as defined by the following laboratory parameters: SGPT(ALT) or SGOT(AST) > 1.5 times the upper limit of normal.

6. Known causes of renal dysfunction other than diabetic nephropathy.

7. Subjects who had a solitary kidney or known renal artery stenosis.

8. NYHA functional class CHF II - IV.

9. Known drug or alcohol dependency.

10. Subjects receiving any investigational therapy within one month of providing written informed consent.

11. Known hypersensitivity to telmisartan or ACE inhibitors or to any component of the formulation.

12. Subjects with a history of suspected angioedema related to ACE inhibitor therapy.