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The Swiss Glucose Variability Study

This study is currently recruiting participants.
Verified August 2011 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01426737
First received: April 18, 2011
Last updated: August 29, 2011
Last verified: August 2011
History of Changes
  Purpose

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

Condition Intervention Phase
Type 2 Diabetes
 Drug: Vildagliptin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Swiss Glucose Variability Study

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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). [ Time Frame: 48h ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Vildagliptin
    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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Male or female patients aged =30 -= 75 years.
  2. History of type 2 diabetes for at least 6 months.
  3. Patients inadequately controlled (i.e. not reaching target) with maximum tolerated doses of metformin with HbA1c of 6.5-9.0%.
  4. 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.
  5. Patients that are currently treated with metformin, gliclazide or both but not with other glucose lowering agents.
  6. Outpatient.
  7. 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.

Exclusion criteria:

  1. Type 1 diabetes as defined by the American Diabetes Association (ADA).
  2. Type 2 diabetes currently (last 3 months) treated with insulin or glitazones.

  3. Acute or chronic diseases causing tissue hypoxia such as:

    • cardiac or respiratory insufficiency
    • myocardial infarct within the last 6 months
  4. Active liver disease with alanine aminotransferase (ALAT) and / or aspartate aminotransferase (ASAT) > 3 x upper limit of normal.

  5. 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
  6. Severe neuropathy (vibration perception at the base of the big toes <2/8).
  7. Active proliferative diabetic retinopathy.
  8. Any clinically relevant major organ system disease including mental illnesses
  9. History of malignancy
  10. Pancreatitis
  11. Porphyria
  12. Severe disturbances of the adrenal gland
  13. Severe disturbances of the thyroid gland
  14. Allergy to vildagliptin or one of the excipients
  15. Allergy to metformin or one of the excipients
  16. Allergy to gliclazide, sulfonylurea or sulfonamides or one of the excipients.
  17. Drug or alcohol abuse.
  18. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).
  19. Any other condition that could interfere with the participation in the study according to the study protocol or with the ability to cooperate and comply with the study procedures.
  20. Treatment with any investigational drug, within 30 days or 5 half-lives before screening, whichever is longer.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426737

Contacts
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Locations
Switzerland
Universitiy Hospital Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01426737     History of Changes
Other Study ID Numbers: CLAF237ACH02T
Study First Received: April 18, 2011
Last Updated: August 29, 2011
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013