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

NCT00738660 | Completed Phase 3

• 1 other identifier: START1DM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Nephropathy

Keywords

type1 DM; microalbuminuria; nephropathy; albumin excretion rate; dual blockade; ACEI; ARB

Outcome Measures

Primary Outcomes (1)

• Reduction in albumin excretion rate

  8 weeks

Secondary Outcomes (1)

• 24 hr ambulatory BP reduction,nocturnal BP reduction, proportion of dippers

  8weeks

Study Arms (1)

A

EXPERIMENTAL

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

Drug: Telmisartan, Ramipril

Interventions

Telmisartan, Ramipril DRUG

80 mg of telmisartan administered for 8weeks,followed by addition of ramipril 10 mg for further 8weeks

Also known as: cardace, cardiopri, tazloc

A

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus by ADA criteria
• Clinical history of DKA
• HbA1C \< 7.5,urine AER \>/= 20 mcg/min on two overnight urine samples

You may not qualify if:

• Pregnancy
• Unwillingness to use contraception during time of study
• Creatinine \>3 mg/dl
• Suspected/proven non diabetic nephropathy
• Active urinary sediment

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 1600012, India

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Kidney Diseases

Interventions

Telmisartan; Ramipril

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• sanjay k bhadada, DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 18, 2008
• First Posted: August 20, 2008
• Study Start: February 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 20, 2008

Record last verified: 2008-08

Locations

IN (1)