The Swiss Glucose Variability Study

NCT01426737 | Unknown Phase 4 DMC

• 1 other identifier: CLAF237ACH02T
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore long term glucose variability of a combination therapy of metformin and vildagliptin compared to a metformin - gliclazide combination. Multicenter, randomized, open, parallel group, Phase IV study, of 18 months duration.

• Trial with medicinal product

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean amplitude of glycemic excursion as described by Service et al. (1970) calculated from the glucose excursions of the CGMS profiles using MiniMedSolution Software (MedtronicMiniMed).

  48h

Interventions

Vildagliptin DRUG

Vildagliptin 50mg twice/d as add-on to metformin alone over 18 months compared to an add-on therapy with gliclazide 30mg max 4x/d(metformin - gliclazide).

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged =30 -= 75 years.
• History of type 2 diabetes for at least 6 months.
• Patients inadequately controlled (i.e. not reaching target) with maximum tolerated doses of metformin with HbA1c of 6.5-9.0%.
• Patients inadequately controlled (i.e. not reaching target) with maximum tolerated doses of metformin with a body mass index (BMI) of 25-40 kg/m2.
• Patients that are currently treated with metformin, gliclazide or both but not with other glucose lowering agents.
• Outpatient.
• If female of childbearing potential: Will to practice reliable birth control measures \[e.g., surgical sterilization, hormonal contraception, double-barrier methods (any double combination of IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)\] during study treatment and for at least 28 days after completion of study medication; not lactating or pregnant; and has a documented negative pregnancy test result at baseline.

You may not qualify if:

• Type 1 diabetes as defined by the American Diabetes Association (ADA).
• Type 2 diabetes currently (last 3 months) treated with insulin or glitazones.
• Acute or chronic diseases causing tissue hypoxia such as:
• cardiac or respiratory insufficiency
• myocardial infarct within the last 6 months
• Active liver disease with alanine aminotransferase (ALAT) and / or aspartate aminotransferase (ASAT) \> 3 x upper limit of normal.
• Relevant kidney disease such as :
• serum creatinine =133 µmol/l in males and \> 124 µmol/l in females
• proteinuria \> 300 mg/l
• status post kidney transplantation
• severe infection
• intravascular administration of contrast medium containing iod within the last 7 days
• Severe neuropathy (vibration perception at the base of the big toes \<2/8).
• Active proliferative diabetic retinopathy.
• Any clinically relevant major organ system disease including mental illnesses

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Universitiy Hospital

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 01 Studienregister MasterAdmins

  UniversitaetsSpital Zuerich

  STUDY DIRECTOR

Central Study Contacts

01 Studienregister MasterAdmins

CONTACT

+41 (0)44 255 11 11

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2011
• First Posted: August 31, 2011
• Study Start: April 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 31, 2011

Record last verified: 2011-08

Locations

CH (1)