Endothelial Effects of Basal Insulin: Detemir Versus Glargine

This study has been completed.
Sponsor:
Information provided by:
University of Padova
ClinicalTrials.gov Identifier:
NCT00699686
First received: June 17, 2008
Last updated: August 16, 2010
Last verified: August 2010
  Purpose

Endothelial progenitor cell (EPC) level represents a surrogate marker of cardiovascular risk and an indicator of the ongoing vascular damage. Moreover, EPCs are involved in the pathogenesis of virtually all diabetic complications. Therefore, ways to modulate EPCs are currently considered of utmost importance, especially in high-risk subjects. While many drugs with pleiotropic vasculoprotective effects have shown ability to positively modulate EPCs, there is no data on the effects of specific insulin formulations.

This is a human randomised cross-over comparison trial. The purpose is to compare the effects of two basal insulin analogues (detemir and glargine) added to oral antidiabetic therapy in poorly-controlled type 2 patients with cardiovascular disease on endothelial function and EPC levels.

The aim is to test whether optimized glycemic control with add-on basal insulin analogues improves endothelial damage and regeneration in type 2 diabetes with macroangiopathy and to compare the effects of glargine vs detemir on markers of endothelial damage and regeneration.

EPC level is the most innovative outcome measure of this study and represents the primary endpoint. Endothelial dysfunction/damage, evaluated using soluble markers, will be the secondary outcome. Given the supposed inverse correlation between EPC and endothelial damage, it is expected that EPC increase reflects amelioration in endothelial biology, a result that may have significant clinical implications in this cohort of high-risk patients.


Condition Intervention Phase
Type 2 Diabetes
Endothelial Dysfunction
Cardiovascular Disease
Drug: Glargine
Drug: Detemir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Optimized Glycemic Control Achieved With add-on Basal Insulin Therapy on Indexes of Endothelial Damage and Regeneration in Type 2 Diabetic Patients With Macroangiopathy. A Randomized Cross-over Trial Comparing Detemir vs Glargine

Resource links provided by NLM:


Further study details as provided by University of Padova:

Primary Outcome Measures:
  • Change in endothelial progenitor cell count [ Time Frame: Basal, 3 months, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in markers of endothelial damage [ Time Frame: Basal, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Frequence of hypoglycemias [ Time Frame: during 1st and 2nd arms ] [ Designated as safety issue: Yes ]
    The frequency of hypoglycemia will be reported for patients on glargine or detemir during the 1st and 2nd period of treatment.

  • Change in body weight [ Time Frame: After the 1st and 2nd arms ] [ Designated as safety issue: Yes ]
    Change in body weight will be assessed after each arm during treatment with glargine or detemir


Estimated Enrollment: 50
Study Start Date: May 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glargine
During this arm/phase patients take subcutaneous glargine daily for 3 months.
Drug: Glargine
Daily bedtime subcutaneous insulin Glargine in individualized doses.
Other Name: Lantus
Experimental: Detemir
During this arm/phase, patients take insulin Detemir subcutaneously for 3 months.
Drug: Detemir
Daily bedtime subcutaneous insulin Detemir in individualized doses.
Other Name: Levemir

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Macroangiopathy (coronary, or peripheral, or cerebrovascular)
  • On oral antidiabetic therapy
  • HbA1c > 7.0%

Exclusion Criteria:

  • Type 1 diabetes
  • Acute diabetic decompensation
  • Use of glitazones
  • Cancer
  • Acute disease or infection
  • Chronic renal failure (serum creatinin > 2.0 mg/dl)
  • Advanced liver disease (Child B-C)
  • Immune disease, organ transplantation, immunosuppression
  • Recent surgery (within 3 months)
  • Recent cardiovascular events (within 3 months)
  • Inability to provide informed consent
  • Pregnancy and lactation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699686

Locations
Italy
Dipartimento di Medicina Clinica e Sperimentale, Divisione di Malattie del Metabolismo
Padova, Italy, 35100
Sponsors and Collaborators
University of Padova
Investigators
Principal Investigator: Angelo Avogaro, M.D. University of Padova, Medical School
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Angelo Avogaro, University of Padova, Medical School
ClinicalTrials.gov Identifier: NCT00699686     History of Changes
Other Study ID Numbers: LIBRA
Study First Received: June 17, 2008
Last Updated: August 16, 2010
Health Authority: Italy: Institutional Review Board
Italy: Ministry of Health

Keywords provided by University of Padova:
Diabetes
Insulin
Endothelium
Cardiovascular disease
Stem cells

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014