Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BfArM N: 4022119
Study information
Scientific title
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
Acronym
Acarbose-Adiponectin Study
Study hypothesis
We aimed to investigate whether a decreased postprandial glucose excursion and portal concentration of insulin by acarbose may improve insulin sensitivity (whole body and local, hepatic insulin sensitivity) and influence the circulating adiponectin levels (as other insulin sensitivity and cardiovascular disease [CVD] markers) in the subjects with different stages of glucose tolerance.
Ethics approval
1. Ethical Committee of Potsdam University approved on the 28th January 2004 (ref: N 9/17)
2. Ethical Committee of Brandenburg approved on the 10th March 2004 (ref: N AS-43/2004)
Study design
Single centre double-blind randomised placebo controlled 2 x 12 weeks cross-over study with a washout period of 12 weeks
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Metabolic syndrome and associated diseases
Intervention
Eligible patients who completed a 3-week run-in period (first wash-out phase), were randomised into two treatment sequences to receive 12 weeks of double-blind treatment. Both treatment sequences consisted of acarbose 100 mg with three main meals and placebo taking three times per day. The total study duration including the wash-out phase was 40 weeks. Patients underwent liquid meal challenges and hyperinsulinemic, euglycemic glucose clamp at weeks 0, 12, 24 and 36.
Intervention type
Drug
Phase
Not Applicable
Drug names
Acarbose
Primary outcome measures
To assess the effect of postprandial glucose reduction by acarbose on insulin sensitivity in subjects with different stages of glucose tolerance.
Measured at the start and at the end of each treatments (12 week duration).
Secondary outcome measures
1. To assess the effects of acarbose on fasting cytokines and on postprandial glucose and insulin metabolism
2. To assess the effects on liver fat content and CVD markers
Measured at the start and at the end of each treatments (12 week duration).
Overall trial start date
02/04/2002
Overall trial end date
01/04/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70 randomised patients
Participant 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
Recruitment start date
02/04/2002
Recruitment end date
01/04/2009
Locations
Countries of recruitment
Germany
Trial participating centre
German Institute of Human Nutrition Potsdam
Nuthetal
14458
Germany
Sponsor information
Organisation
Bayer Schering Pharma AG (Germany)
Sponsor details
c/o Dr. Peter Marx
Global Scientific Affairs Manager CVRM
Müllerstraße 170
Berlin
13353
Germany
Sponsor type
Industry
Website
Funders
Funder type
Government
Funder name
Federal Ministry for Education and Research (Bundeministerium für Bildung und Forschung [BMBF]) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Firma Bayer Vital (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Firma BRAHMS AG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22990716
Publication citations
-
Results
Rudovich N, Pivovarova O, Traberth A, Sparwasser A, Weickert MO, Bernigau W, Birkenfeld AL, Arafat AM, Bergmann A, Pfeiffer AF, Acarbose treatment enhances mid-regional pro-atrial natriuretic peptide concentrations in non-diabetic individuals: further evidence for a common cardiometabolic pathway?, Diabetologia, 2012, 55, 12, 3392-3395, doi: 10.1007/s00125-012-2724-9.