Efficacy of Telmisartan and the Combination of Telmisartan and Ramipril in type1 Diabetes Patients With Nephropathy (START1DM)

This study has been completed.
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT00738660
First received: August 18, 2008
Last updated: August 19, 2008
Last verified: August 2008

August 18, 2008
August 19, 2008
February 2007
May 2008   (final data collection date for primary outcome measure)
Reduction in albumin excretion rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00738660 on ClinicalTrials.gov Archive Site
24 hr ambulatory BP reduction,nocturnal BP reduction, proportion of dippers [ Time Frame: 8weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Telmisartan and the Combination of Telmisartan and Ramipril in type1 Diabetes Patients With Nephropathy
Efficacy of Telmisartan and the Combination of Telmisartan and Ramipril in type1 Diabetes Patients With Nephropathy

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.

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.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Nephropathy
Drug: Telmisartan, Ramipril
80 mg of telmisartan administered for 8weeks,followed by addition of ramipril 10 mg for further 8weeks
Other Names:
  • cardace
  • cardiopri
  • tazloc
Experimental: A
single experimental arm cross over of patients, addition of Ramipril onto Telmisartan.
Intervention: Drug: Telmisartan, Ramipril
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
14 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00738660
START1DM
No
Sanjay K Bhadada, Post graduaate institute of medical education and research
Postgraduate Institute of Medical Education and Research
Not Provided
Principal Investigator: sanjay k bhadada, DM post graduate institute of medical education and research
Postgraduate Institute of Medical Education and Research
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP