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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 18, 2008

Last Updated Date

August 19, 2008

Start Date ^†

February 2007

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00738660 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief Summary

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.

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study

Condition ^†

Diabetic Nephropathy

Intervention ^†

Drug: Telmisartan, Ramipril

Study Arms / Comparison Groups

Experimental: single experimental arm cross over of patients, addition of Ramipril onto Telmisartan.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

14 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

India

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00738660

Responsible Party

Sanjay K Bhadada, Post graduaate institute of medical education and research

Secondary IDs ^††

Study Sponsor ^†

Postgraduate Institute of Medical Education and Research

Collaborators ^††

Investigators ^†

Principal Investigator:

sanjay k bhadada, DM

post graduate institute of medical education and research

Information Provided By

Postgraduate Institute of Medical Education and Research

Verification Date

August 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.