Efficacy of Telmisartan and the Combination of Telmisartan and Ramipril in type1 Diabetes Patients With Nephropathy (START1DM)
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.
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy of Telmisartan and the Combination of Telmisartan and Ramipril in type1 Diabetes Patients With Nephropathy|
- Reduction in albumin excretion rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- 24 hr ambulatory BP reduction,nocturnal BP reduction, proportion of dippers [ Time Frame: 8weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
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
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738660
|Post Graduate Institute of Medical Education and Research|
|Chandigarh, India, 1600012|
|Principal Investigator:||sanjay k bhadada, DM||post graduate institute of medical education and research|