The Effects of Insulin Detemir and Gliclazide-MR Treatments on Endothelial Functions in Patients With Type 2 Diabetes

NCT01420692 | Completed DMC

• 1 other identifier: 110S119
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to analyze the effects of the addition of sulfonylurea (gliclazide MR) or ,alternatively, basal insulin (insulin detemir) to life-style modification and metformin treatment as a second step treatment in type 2 diabetes mellitus on endothelial cell functions. The second goal is to identify the effects of these treatment alternatives on body-mass index, the changes in body fat mass, insulin resistance and on the insulin secretion capacity of beta cells. The third aim of this study is to determine the success rates of these treatment alternatives on glycemic control at 6 months follow-up.

Conditions

Type 2 Diabetes Mellitus

Keywords

Tip 2 DM; Endothelium; Gliclazide; Insulin detemir

Outcome Measures

Primary Outcomes (2)

• The evaluation of the changes in Flow-Mediated Dilatation (FMD) at 12th and 24th weeks compared to the baseline level, as a Measure of Endothelial Function

  As soon as type 2 DM patients which were randomly recruited either to the Gliclazide MR arm or the Insulin Detemir arm reach to target glycemic levels (0. week), flow-mediated dilatation test, which is a basal tests showing endothelial function will be performed. This basal test will be reapeated in each study subject, 12 weeks and 24 weeks after reaching the target glycemic levels.

  The basal, 12th and 24th week after reaching the target glycemic levels

• The Changes in the Peripheral Blood Levels of TNF-α, IL-6, MCP-1, sICAM-1, sVCAM-1, vWF, E-selectin, P-selectin, Endothelin-1, PAI-1, tPA and HMW Adiponectin at 12th and 24th weeks compared to the baseline level, as Measures of Inflam. and Coagulation

  As soon as type 2 DM patients which were randomly recruited either to the Gliclazide MR arm or the Insulin Detemir arm reach to target glycemic levels (0. week), basal tests showing endothelial function as well as inflammatory and coagulation status such as flow-mediated dilatation and peripheral blood TNF-α, IL-6, MCP-1, sICAM-1, sVCAM-1, vWF, E-selectin, P-selectin, endothelin-1, PAI-1, tPA and HMW adiponectin levels will be performed. These basal tests will be reapeated in each study subject, 12 weeks and 24 weeks after reaching the target glycemic levels.

  The basal, 12th and 24th week after reaching the target glycemic levels

Secondary Outcomes (1)

• Calculation of Body-mass Index, Body Fat Mass, Level of Insulin Resistance and the Insulin Secretion Capacity of Pancreatic Beta Islet Cells as Measures to Identify the Effects of Gliclazide and Insulin Detemir Treatments on Diabetes Progression

  The basal, 12th and 24th week after reaching the target glycemic levels

Study Arms (2)

Gliclazide MR

ACTIVE COMPARATOR

Drug: Gliclazide MR

Insulin Detemir

ACTIVE COMPARATOR

Early initiation of insulin detemir in contrast to Gliclazide MR treatment

Drug: Insulin Detemir

Interventions

Gliclazide MR DRUG

Doses between 30 mg to 120 mg/day p.o. Gliclazide MR will be arranged according to the target glycemic levels.

Also known as: Diamicron MR

Gliclazide MR

Insulin Detemir DRUG

Early initiation of s.c. insulin detemir in contrast to Gliclazide MR. Insulin detemir treatment will be exchanged to Gliclazide MR after 12 weeks.

Also known as: Levemir Flexpen

Insulin Detemir

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetic patients using at least 1000 mg/day metformin at least for 3 months
• \<A1C ≤ 11
• Patients without any previous use of oral antidiabetics other than metformin or insulin
• Between 20 to 65 years old male or female patients

You may not qualify if:

• Active hepatic disease
• Serum creatinin 1,5 mg/dl or more for males, 1,4 or more for females
• Proliferative Diabetic Retinopathy
• Coronary Artery Disease
• Patients with any kind of diagnosed malignancy
• Pregnancy and Lactation
• Fasting C-peptide levels lower than 2.0 ng/ml
• Smoking or drug abuse

Sponsors & Collaborators

• Ankara University: lead
• Hacettepe University: collaborator
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Ankara University Medical Faculty Dept. of Endocrinology and Metabolism

Ankara, 06100, Turkey (Türkiye)

Location

Related Links

• Hacettepe University Web Page

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Gliclazide; Insulin Detemir

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ugur Unluturk, MD

  Ankara University Medical Faculty Dept. of Endocrinology and Metabolism

  PRINCIPAL INVESTIGATOR

• Altug S Kesikli, MD. PhD.

  Hacettepe University Instute of Oncology Dept. of Basic Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Endocrinology and Metabolism

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: August 22, 2011
• Study Start: June 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 14, 2012

Record last verified: 2012-08

Locations

TU (1)