Glargine Versus NPH in Patients With Chronic Kidney Disease
Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · May 21, 2015
Trial Information
Current as of July 25, 2025
Completed
Keywords
ClinConnect Summary
This study consists of a randomized, cross-over, open-label controlled clinical trial. Randomized patients will be allocated alternately into two groups to receive the following therapies: GROUP 1 - insulin analog glargine once a day associated to insulin lispro at mealtime and GROUP 2 - NPH human insulin, three applications per day ( breakfast, lunch and bedtime) and insulin lispro at mealtime. Patients receiving insulin NPH plus insulin lispro will be oriented to mix both of them in the same syringe at breakfast and lunchtime. The laboratory tests will be performed at baseline and 12, 24,...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients with type 2 diabetes mellitus and chronic kidney disease secondary to diabetic nephropathy in stages 3 and 4 (moderate and severe nephropathy, corresponding to glomerular filtration rate of 15-59 ml/min/1.73m²) will be included in the study.
- Exclusion Criteria:
- • Patients with systemic neoplasias,
- • HIV, chronic kidney disease or nephropathy from other etiologies,
- • severe psychiatric disorders
- • pregnant women.
About University Of Sao Paulo General Hospital
The University of São Paulo General Hospital (Hospital das Clínicas da Universidade de São Paulo) is a leading clinical research institution in Brazil, renowned for its commitment to advancing medical knowledge and patient care. As an academic hospital affiliated with one of the largest and most prestigious universities in Latin America, it integrates clinical practice, education, and research. The hospital conducts a wide array of clinical trials across various medical disciplines, aiming to develop innovative therapies and improve healthcare outcomes. With a multidisciplinary team of healthcare professionals and access to cutting-edge facilities, the University of São Paulo General Hospital is dedicated to fostering scientific advancements and addressing critical health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sao Paulo, , Brazil
Patients applied
Trial Officials
Marcia S Queiroz, MD, PhD
Principal Investigator
Assistant Professor at Division of Endocrinology and Metabolism, Department of Internal Medicine, Clinic Hospital of the University of São Paulo Medical School
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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