Status:
UNKNOWN
The Swiss Glucose Variability Study
Lead Sponsor:
University of Zurich
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
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,...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01426737
Start Date
April 1 2011
End Date
January 1 2013
Last Update
August 31 2011
Active Locations (1)
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1
Universitiy Hospital
Zurich, Switzerland