Type 2 diabetes. The effect of Nexium on insulin secretion and glycemic control in patients with type 2 diabtes. MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Trade Name: Nexium
Product Name: Nexium
Pharmaceutical Form: Tablet
INN or Proposed INN: Esomeprazol
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Produc
Sponsors
Steno Diabetes Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type 2 diabetes (WHO criteria) treated with oral antidiabetic medication Metformin, SU, or diet. I a stable fase 3-4 month prior to the start of the trial. Age: 40 -70 years C-peptide concentration > 0,3 pmol/l HbA1c between 7 - 10 the last year. Diabetes duration > 2 years BMI>25 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Kidney disease Liver disease seriuos heartdisease Cancer or other serious metabolic disease Pregnancy or planned pregnancy Alcohol or other abuse Allergy towards trail medication Medical interaction towards trail medication severe neuropathy severe retinopathy BP>170/95
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) Insulinsecretion as indicated as the area under the serum insulin curve(AUC) after 3 months treatment ;Secondary Objective: C-peptid, proinsulin, glucose, GLP-1, GIP Gastrin secretion HbA1c Insulinresistence in the CLAMP test ;Primary end point(s): Insulinsecretion as indicated as the area under the serum insulin curve (AUC) after 3 month treatment of Nexium | — |
Countries
Denmark
Outcome results
None listed