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

Diabetic Nephropathy Clinical Trial

— START1DM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738660
• Other study ID #: START1DM
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2008
• Last updated: August 19, 2008
• Start date: February 2007
• Est. completion date: May 2008

Study information

• Verified date: August 2008
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• Telmisartan, Ramipril
80 mg of telmisartan administered for 8weeks,followed by addition of ramipril 10 mg for further 8weeks

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in albumin excretion rate		8 weeks	No
Secondary	24 hr ambulatory BP reduction,nocturnal BP reduction, proportion of dippers		8weeks	No