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

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ClinicalTrials.gov Identifier: NCT00738660
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : August 20, 2008
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: Telmisartan, Ramipril Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Telmisartan and the Combination of Telmisartan and Ramipril in type1 Diabetes Patients With Nephropathy
Study Start Date : February 2007
Primary Completion Date : May 2008
Study Completion Date : May 2008

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
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
Other Names:
  • cardace
  • cardiopri
  • tazloc


Outcome Measures

Primary Outcome Measures :
  1. Reduction in albumin excretion rate [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. 24 hr ambulatory BP reduction,nocturnal BP reduction, proportion of dippers [ Time Frame: 8weeks ]

Eligibility Criteria

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Sanjay K Bhadada, Post graduaate institute of medical education and research
ClinicalTrials.gov Identifier: NCT00738660     History of Changes
Other Study ID Numbers: START1DM
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: August 20, 2008
Last Verified: August 2008

Keywords provided by Postgraduate Institute of Medical Education and Research:
type1 DM
microalbuminuria
nephropathy
albumin excretion rate
dual blockade
ACEI
ARB

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Urologic Diseases
Diabetes Complications
Telmisartan
Ramipril
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors