The Swiss Glucose Variability Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01426737
Recruitment Status : Unknown
Verified August 2011 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : August 31, 2011
Last Update Posted : August 31, 2011
Information provided by (Responsible Party):
University of Zurich

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Vildagliptin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Swiss Glucose Variability Study
Study Start Date : April 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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).

Primary Outcome Measures :
  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). [ Time Frame: 48h ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01426737

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

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

Responsible Party: University of Zurich Identifier: NCT01426737     History of Changes
Other Study ID Numbers: CLAF237ACH02T
First Posted: August 31, 2011    Key Record Dates
Last Update Posted: August 31, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs