- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01426737
The Swiss Glucose Variability Study
August 29, 2011 updated by: University of Zurich
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
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zurich, Switzerland
- Recruiting
- Universitiy Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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).
Time Frame: 48h
|
48h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Anticipated)
January 1, 2013
Study Completion (Anticipated)
January 1, 2013
Study Registration Dates
First Submitted
April 18, 2011
First Submitted That Met QC Criteria
August 29, 2011
First Posted (Estimate)
August 31, 2011
Study Record Updates
Last Update Posted (Estimate)
August 31, 2011
Last Update Submitted That Met QC Criteria
August 29, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLAF237ACH02T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes
-
Antonio Di MauroCompletedType-2 DiabetesItaly
-
DiaMedica Therapeutics IncCompletedDiabetes Type 2Netherlands
-
RenJi HospitalUnknownType 2 Diabetes.China
-
University of Erlangen-Nürnberg Medical SchoolCompletedType 2-diabetesGermany
-
Chengdu Brilliant Pharmaceutical Co., Ltd.Not yet recruitingType 2 Diabetes Mellitus
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingType 2 Diabetes MellitusChina
-
Xiangya Hospital of Central South UniversityRecruitingType 2 Diabetes MellitusChina
-
University of Alabama at BirminghamCompletedType 2 Diabetes MellitusUnited States
-
Imperial College LondonAstraZeneca; Huma; North West London Collaboration of CCGs (NWL CCGs); Imperial...CompletedType 2 Diabetes MellitusUnited Kingdom
-
Universiti Sains MalaysiaCompleted
Clinical Trials on Vildagliptin
-
Laboratorios Silanes S.A. de C.V.Recruiting
-
Novartis PharmaceuticalsCompletedType II Diabetes Mellitus | Congestive Heart FailureRussian Federation, Singapore, Italy, Czechia, Lithuania, Germany, Guatemala, India, Denmark, Estonia, Slovakia, Romania, Latvia, Greece, Poland
-
Novartis PharmaceuticalsCompletedType 2 Diabetes MellitusSpain, Poland, South Africa, Taiwan, Hong Kong, Norway, Italy, Bulgaria, Latvia, Lithuania, Germany, Turkey, Argentina, Israel, Korea, Republic of, Dominican Republic, Guatemala, Brazil, Colombia, Peru, Philippines, Russian Federation and more
-
Novartis PharmaceuticalsCompletedDiabetes Mellitus, Type 2Switzerland, Germany
-
Novartis PharmaceuticalsCompletedDiabetes Mellitus, Type 2United States, Germany
-
NovartisCompleted
-
Bio-innova Co., LtdNot yet recruiting
-
Radboud University Medical CenterCompletedType 2 Diabetes | Endothelial DysfunctionNetherlands
-
NovartisCompletedDiabetes Mellitus, Type 2United States, Germany
-
Novartis PharmaceuticalsCompletedDiabetes Mellitus, Type 2United States