ISRCTN40281673CompletedNot Applicable
Single centre, double-blind, randomised, placebo controlled, cross-over study to investigate the effects of postprandial glucose reduction by acarbose on insulin sensitivity and cardio-vascular markers in type 2 diabetes patients, subjects with impaired glucose tolerance and normal glucose tolerant subjects
Bayer Schering Pharma AG (Germany)0 sites70 target enrollmentStarted: June 29, 2010Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 70
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
Investigators
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