Efficacy of Telmisartan and the Combination of Telmisartan and Ramipril in type1 Diabetes Patients With Nephropathy - Full Text View

Purpose

Hypothesis:

The angiotensin receptor blocker telmisartan is effective at reduction of albumin excretion rate(AER) in patients with type1 diabetes and micro or macroalbuminuria. Dual blockade with the addition of ramipril an angiotensin receptor blocker gives added efficacy for reduction of AER. ARB telmisartan gives a 24 hr BP lowering effect.

Summary:

This is an open label cross over study involving 30 patients who were initially treated with Telmisartan 80 mg for eight weeks followed by addition of Ramipril 10 mg for a further eight weeks. Albuminuria reduction and BP reduction with both clinic and ambulatory BP records were studied at the end of each phase.

Condition	Intervention	Phase
Diabetic Nephropathy	Drug: Telmisartan, Ramipril	Phase III

MedlinePlus related topics:

Diabetes Diabetes Type 1 Diabetic Kidney Problems

ChemIDplus related topics:

Ramipril Telmisartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study

Official Title:	Efficacy of Telmisartan and the Combination of Telmisartan and Ramipril in type1 Diabetes Patients With Nephropathy

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:

Reduction in albumin excretion rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

24 hr ambulatory BP reduction,nocturnal BP reduction, proportion of dippers [ Time Frame: 8weeks ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	February 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental single experimental arm cross over of patients, addition of Ramipril onto Telmisartan.	Drug: Telmisartan, Ramipril 80 mg of telmisartan administered for 8weeks,followed by addition of ramipril 10 mg for further 8weeks

Detailed Description:

To evaluate the antialbuminuric efficacy of an angiotensin receptor blocker (ARB) telmisartan and the combination of telmisartan and ramipril in patients with type1 DM and either micro or macroalbuminuria.To evaluate the same drugs for their antihypertensive efficacy and their influence on dipping patterns using ambulatory BP monitoring.

Methods:

Open label cross over study involving 30 patients who were initially treated with telmisartan 80 mg for eight weeks followed by addition of ramipril 10 mg for a further eight weeks. Albuminuria reduction and BP reduction with both clinic and ambulatory BP records were studied at the end of each phase Overnight urine samples of nine hours duration were collected . The volume of urine was verified by measurement in a jar with accuracy of 50ml by the study investigator on every occasion. . Albuminuria was estimated by immuno-turbidimetry Hemocue albumin system Angelholm AD, Sweden (inter assay CV 4.3% ). The albumin excretion rate(AER) at baseline evaluation was determined as the mean AER of the positive urine samples. During subsequent evaluations at the end of 8weeks and at the end of 16 weeks the mean albumin excretion rate from two successive overnight urine samples was taken as the mean .Ambulatory BP (ABP) measurement :ABP was measured using Spacelabs device 90207 Spacelabs inc. use of which is described before(14) .A uniform protocol of inflation once in every 30 min was used. Cuff was applied to the nondominant arm. Recordings were started in all patients between seven and ten AM.

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diabetes mellitus by ADA criteria
Clinical history of DKA
HbA1C < 7.5,urine AER >/= 20 mcg/min on two overnight urine samples

Exclusion Criteria:

Pregnancy
Unwillingness to use contraception during time of study
Creatinine >3 mg/dl
Suspected/proven non diabetic nephropathy
Active urinary sediment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738660

Locations


India
	Post Graduate Institute of Medical Education and Research
	chandigarh, India, 1600012

Sponsors and Collaborators

Postgraduate Institute of Medical Education and Research

Investigators


Principal Investigator:	sanjay k bhadada, DM	post graduate institute of medical education and research

More Information

Responsible Party:	Post graduaate institute of medical education and research ( Sanjay K Bhadada )
Study ID Numbers:	START1DM
First Received:	August 18, 2008
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00738660
Health Authority:	India: Institutional Review Board

Keywords provided by Postgraduate Institute of Medical Education and Research:

type1 DM

microalbuminuria

nephropathy

albumin excretion rate

dual blockade

ACEI

ARB

Study placed in the following topic categories:

Diabetic Nephropathies

Metabolic Diseases

Autoimmune Diseases

Diabetes Mellitus

Endocrine System Diseases

Angiotensin II

Ramipril

Diabetes Mellitus, Type 1

Urologic Diseases

Telmisartan

Kidney Diseases

Endocrinopathy

Glucose Metabolism Disorders

Metabolic disorder

Diabetes Complications

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers

Molecular Mechanisms of Pharmacological Action

Immune System Diseases

Therapeutic Uses

Angiotensin-Converting Enzyme Inhibitors

Enzyme Inhibitors

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

Protease Inhibitors

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Postgraduate Institute of Medical Education and Research
Information provided by:	Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:	NCT00738660