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DOES BENFOTIAMINE SUPPLEMENTATION REDUCE SERUM LEVELS OF ADVANCED GLYCATION END PRODUCTS AND BIOCHEMICAL MARKERS OF VASCULAR DYSFUNCTION IN TYPE 1 DIABETES?

DOES BENFOTIAMINE SUPPLEMENTATION REDUCE SERUM LEVELS OF ADVANCED GLYCATION END PRODUCTS AND BIOCHEMICAL MARKERS OF VASCULAR DYSFUNCTION IN TYPE 1 DIABETES?

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-000799-15-NO
Enrollment
Unknown
Registered
2004-06-25
Start date
2004-09-09
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes

Interventions

Trade Name: Milgamma mono 150 Product Name: Milgamma mono 150 Product Code: 6858712.00.00 Pharmaceutical Form: Film-coated tablet Pharmaceutical form of the placebo: Film-coated tablet Route of admini

Sponsors

Aker University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Genders Eligible for Study: Both Age 18 to 60 years, inclusive. Type 1 diabetes mellitus for at least 5 years as defined by the following: a. Insulin dependence b. C-peptide 15 ug/min in two out of three overnight urine samples) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Symptomatic gastroparesis. Urine albumin > 200 ug/min in timed overnight urine collection. Diabetic nephropathy with a creatinine clearance less than 60 cc/min. Evidence of chronic infection. History of any malignancy. Any chronic medical condition that unduly increase risk for the potential enrollee as judged by study investigators. Pregnancy, breastfeeding or planned pregnancy within two years.

Design outcomes

Primary

MeasureTime frame
Main Objective: TO ASSESS WHETHER BENFOTIAMINE SUPPLEMENTATION REDUCES SERUM LEVELS OF ADVANCED GLYCATION END PRODUCTS AND BIOCHEMICAL MARKERS OF VASCULAR DYSFUNCTION IN PATIENTS WITH TYPE 1 DIABETES;Secondary Objective: TO ASSESS WHETHER BENFOTIAMINE SUPPLEMENTATION REDUCES URINARY ALBUMIN EXCRETION;Primary end point(s): AGEs: AGE, Ne-(carboxymethyl)lysine (CML), and hydroimidazolone (HI) C-reactive protein (CRP), serum vascular cell adhesion molecule-1 (VCAM-1), interleukin (IL)-6.—

Countries

Norway

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026