The Swiss Glucose Variability Study

Type 2 Diabetes Clinical Trial

Official title:

The Swiss Glucose Variability Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01426737
• Other study ID #: CLAF237ACH02T
• Status: Recruiting
• Phase: Phase 4
• First received: April 18, 2011
• Last updated: August 29, 2011
• Start date: April 2011
• Est. completion date: January 2013

Study information

• Verified date: August 2011
• Source: University of Zurich
• Contact: 01 Studienregister MasterAdmins
• Phone: +41 (0)44 255 11 11
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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).

Locations

Country	Name	City	State
Switzerland	Universitiy Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No