The Swiss Glucose Variability Study

Study Overview
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Brief Summary
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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

Official Title
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The Swiss Glucose Variability Study

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Vildagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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. Exclusion criteria: 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 History of malignancy Pancreatitis Porphyria Severe disturbances of the adrenal gland Severe disturbances of the thyroid gland Allergy to vildagliptin or one of the excipients Allergy to metformin or one of the excipients Allergy to gliclazide, sulfonylurea or sulfonamides or one of the excipients. Drug or alcohol abuse. 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). 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. Treatment with any investigational drug, within 30 days or 5 half-lives before screening, whichever is longer.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |