Official Title: “The Effect of Nexium and Cardi-04 Yoghurt on Insulin Secretion and Effect and Cardi Vascular Risk Factors Associated With the Insulin Syndrome in Patients With Type 2 Diabetes - a Randomized Double-Blind, Prospective, Placebo Controlled 2 x 2 Factorial Design 3 Month's Study.”

To test the effect of Nexium and probiotics on insulin secretion and cardiovascular risk factors on type 2 diabetic patients.

Study Hypothesis:

1. Nexium causes an increased gastrin secretion that increases the insulin secretion and thereby a reduction of HbA1c

2. Probiotics changes the gut flora and bloodpressure

3. Probiotics causes a change in inflammation and thrombosis.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study

Study Primary Completion Date: May 2009

Intervention(s) in this Clinical Trial

• Drug: nexium
  • 40 mg once daily is tested together with Yoghurt
• Drug: nexium
  • nexium and placebo are tested
• Dietary Supplement: Yoghurt
  • Yoghurt
• Drug: placebo+placebo
  • placebo and placebo are tested.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Nexium + Yoghurt
• Placebo Comparator: Nexium + Placebo
• Placebo Comparator: Placebo+ Yoghurt
• Placebo Comparator: placebo+placebo

Primary Measures

• insulin secretion
  • Time Frame: 1 year
    Safety Issue?: No

Secondary Measures

• blood pressure
  • Time Frame: 1 year
    Safety Issue?: No

Inclusion Criteria:

• Type 2 diabetes
• Males and females between 40 and 70 years
• Fasting C-peptide> 0,3 pmol/l within the last year
• HbA1c between 7-10 within the last year
• Blood pressur between 130-170/95 mm Hg

Exclusion Criteria:

• Kidney disease
• Macroalb.
• Heart failure(NYHA class lll or lV)
• Alcohol abuse
• Drug abuse
• Other acute or chronic disease
• C-peptide< 0,3
• Medicin interaction
• PPI or other medications for ulcus diseases
• Treatment with steroid or other hormone treatment
• Bloodpressure>170/105 mmHg
• Bloodpressure<130/85 mmHg
• Neutropenia or anemia
• Treatment with warfarin or other coumarin derivations
• Pregnant or breestfeeding women
• Allergy to medication used in the study
• Lever disease

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Steno Diabetes Center

Overall Clinical Trial Officials and Contacts

Allan A. Vaag, MD, DMSc Principal Investigator Steno Diabetes Center  

Overall Contact: Allan A Vaag, MD,DMSC 45-4443-9214 avaa@steno.dk

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00699426

Study ID Number: EudraCT: 2007-00405237

ClinicalTrials.gov Identifier: NCT00699426

Health Authority: Denmark: Ethics Committee