Type 2 DiabetesPhase 3NCT00551954
Effects of Acarbose on Endothelial Function After a Mixed Meal in Newly Diagnosed Type 2 Diabetes
A Phase 3 study testing acarbose in people with Type 2 Diabetes, run by Technische Universität Dresden.
Trial summary
Endothelial dysfunction (ED) has been suggested as a possible causal link between postprandial hyperglycemia and cardiovascular events in patients with type 2 diabetes. Recent trials demonstrated a reduction of cardiovascular events by treatment with the alpha glucosidase inhibitor acarbose - a drug which mainly… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- acarbose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 2006to Jul 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 35-75 years
- type 2 diabetes (newly diagnosed)
- well glycemic control (HbA1c </= 8.1)
- leucocyte count > 6.2 or hs CrP > 1
Who cannot join
- hs CrP > 10
- type 1 diabetes
- previous treatment with antidiabetic drugs
About this study
Endothelial dysfunction (ED) has been suggested as a possible causal link between postprandial hyperglycemia and cardiovascular events in patients with type 2 diabetes. Recent trials demonstrated a reduction of cardiovascular events by treatment with the alpha glucosidase inhibitor acarbose - a drug which mainly reduces postprandial glucose excursions. We were interested whether patients with newly diagnosed type 2 diabetes showed postprandial ED and if so whether acarbose was able to improve this condition.
- Conditions
- Type 2 Diabetes
- Being tested
- acarbose, placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acarboseDrug
100 mg (tablets) t.i.d.
placeboDrug
one tablet t.i.d.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 20 weeks of treatment with acarbose (100 mg t.i.d.) Receives: Drug: acarbose |
| 2 | Placebo comparator | 20 weeks of treatment with placebo (one tablet t.i.d.) Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
forearm blood flow assessed by forearm occlusion plethysmography after a mixed meal
Measured: at baseline and after 20 weeks of treatment
Secondary outcomes (1)
forearm blood flow assessed by forearm occlusion plethysmography in the fasting state, plasma glucose excursion in response to the mixed meal, insulin levels in response to the mixed meal, triglyceride levels in response to the mixed meal
Measured: at baseline and after 20 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study startJul 2006
- Primary completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markolf Hanefeld, PhD, Principal investigator, Center for Clinical Studies, Fiedlerstr. 34, 01307 Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551954
- Sponsor's protocol ID
- AIDA a4
- Status last verified
- Feb 2013
- First submitted
- 31 Oct 2007
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acarbose on Endothelial Function After a Mixed Meal in Newly Diagnosed Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00551954
- Acronym / sponsor ID
- AIDA a4
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jul 2007 (actual)
- First posted
- 1 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endothelial dysfunction (ED) has been suggested as a possible causal link between postprandial hyperglycemia and cardiovascular events in patients with type 2 diabetes. Recent trials demonstrated a reduction of cardiovascular events by treatment with the alpha glucosidase inhibitor acarbose - a drug which mainly reduces postprandial glucose excursions. We were interested whether patients with newly diagnosed type 2 diabetes showed postprandial ED and if so whether acarbose was able to improve this condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: acarbose20 weeks of treatment with acarbose (100 mg t.i.d.) |
| 2 | Placebo comparator | Drug: placebo20 weeks of treatment with placebo (one tablet t.i.d.) |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 35-75 years
- type 2 diabetes (newly diagnosed)
- well glycemic control (HbA1c </= 8.1)
- leucocyte count > 6.2 or hs CrP > 1
Key exclusion criteria (3 listed)
- hs CrP > 10
- type 1 diabetes
- previous treatment with antidiabetic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acarbose100 mg (tablets) t.i.d. | Drug | 1 |
| placeboone tablet t.i.d. | Drug | 2 |
Primary outcome
forearm blood flow assessed by forearm occlusion plethysmography after a mixed meal
Time frame: at baseline and after 20 weeks of treatment
1 secondary outcome
forearm blood flow assessed by forearm occlusion plethysmography in the fasting state, plasma glucose excursion in response to the mixed meal, insulin levels in response to the mixed meal, triglyceride levels in response to the mixed meal
Time frame: at baseline and after 20 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markolf Hanefeld, PhD principal investigator
Center for Clinical Studies, Fiedlerstr. 34, 01307 Dresden, Germany
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acarbose in people with Type 2 Diabetes, run by Technische Universität Dresden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forearm blood flow assessed by forearm occlusion plethysmography after a mixed meal (time frame: at baseline and after 20 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2013.