Investigation of the effects of postprandial glucose reduction by acarbose on insulin sensitivity and cardio-vascular markers in the subjects with different stages of glucose tolerance

Completed

• Conditions: Metabolic syndrome and associated diseases; Nutritional, Metabolic, Endocrine; Metabolic syndrome

• Registration Number: ISRCTN40281673
• Lead Sponsor: Bayer Schering Pharma AG (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Males or females, aged between 18 and 75 years inclusive
2. Newly diagnosed type 2 diabetes, or previously treated with diet and/or exercise or treated with metformin or acarbose as monotherapy or with impaired glucose tolerance (IGT)/impaired fasting glucose (IFG) or with normal glucose tolerance
3. Female patients were either non-fertile or willing to use a medically approved birth control method during the whole duration of the study
4. Body mass index (BMI) between 20 and 40 kg/m^2
5. Fasting plasma glucose (FPG) less than 15 mmol/1
6. Fasting C-peptide greater than 1 ng/ml

Exclusion Criteria

1. On treatment with insulin, insulin secretagogues, corticosteroids (with the exception of inhaled corticosteroids), thiazolidindiones derivates and monoaminooxidase inhibitors
2. Known sensitivity to drugs similar to acarbose
3. Serum creatinine greater than 1.5 mg/dl or pre-existing end-stage nephropathy
4. On laser treatment for diabetes related retinopathy within 3 months prior to study start
5. Alanine aminotransferase (ALAT) greater than 2.5 times of normal range
6. Type 1 diabetes mellitus
7. Thyroid stimulating hormone (TSH) outside of normal range
8. Medical history or signs of chronically gastrointestinal diseases with diarrhoea, flatulence and absorption anomalies

Study & Design

• Study Type: Interventional
• Study Design: Not specified