Type 2 Diabetes MellitusPhase 4EDIPNCT01470937
Early Diabetes Intervention Program
A Phase 4 study testing Acarbose in people with Type 2 Diabetes Mellitus, run by Indiana University at 1 site in United States.
Trial summary
This is an evaluation of the effect of acarbose to delay worsening of fasting glucose control in early Type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Acarbose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1998to Sep 2004
- Phase
- Phase 4
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fasting plasma glucose <140 mg/dL
- 75 g OGTT 2hr glucose >120 mg/dL
- BMI > 25 OR history of gestational diabetes mellitus OR family history of type 2 diabetes
- Age at least 25 years
Who cannot join
- Cancer within 5 years
- Chronic infectious disease (HIV, Hepatitis)
- CVD event within 6 months
- Uncontrolled hypertension or requiring beta blockers or thiazide diuretics for control
- elevated AST or ALT
- Serum creatinine >1.4 mg/dL (men) or >1.3 mg/dL (women)
Show all 9Show fewer
- TG >600 mg/dL
- Known glucosidase intolerance
- Inability to comply with protocol requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital GCRC
Indianapolis, Indiana, 46202
About this study
This is an evaluation of the effect of acarbose to delay worsening of fasting glucose control in early Type 2 diabetes mellitus.
Read the detailed description
A double blind, randomized, placebo-controlled clinical trial of acarbose in subjects with type 2 diabetes (an FDA-approved indication). Subjects were identified who had diabetes by glucose tolerance test criteria but non-diabetic fasting glucose concentrations. Treatment interventions were assessed for their ability to delay worsening of fasting glucose control.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Acarbose, Placebo
- Keywords
- diabetes acarbose alphaglucosidase prevention
- 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
Also called Precose
acarbose 100 mg PO once daily
PlaceboDrug
acarbose placebo
| Study group | Role | What they receive |
|---|---|---|
| Acarbose | Experimental | acarbose 100 mg once daily Receives: Drug: Acarbose |
| Placebo | Placebo comparator | Matched placebo was administered for acarbose 100 mg once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of fasting glucose >140 mg/dL
Fasting plasma glucose was measured quarterly for up to 5 years. Two consecutive measures above 140 mg/dL defined progression.
Measured: From date of randomization until the date of first documented progression or censoring, up to 5 years post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startFeb 1998
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Kieren Mather, Indiana University
- Investigators
- Kieren J Mather, MD, Principal investigator, Indiana UniversityRobert V Considine, PhD, Principal investigator, Indiana UniversityMarian S Kirkman, MD, Study director, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470937
- Sponsor's protocol ID
- 9705-34
- Acronym
- EDIP
- Status last verified
- Nov 2011
- First submitted
- 27 Oct 2011
- Last updated
- 11 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kirkman MS, Shankar RR, Shankar S, Shen C, Brizendine E, Baron A, McGill J. Treating postprandial hyperglycemia does not appear to delay progression of early type 2 diabetes: the Early Diabetes Intervention Program. Diabetes Care. 2006 Sep;29(9):2095-101. doi: 10.2337/dc06-0061.
PubMed 16936159Patel YR, Kirkman MS, Considine RV, Hannon TS, Mather KJ. Changes in Weight and Glucose Can Protect Against Progression in Early Diabetes Independent of Improvements in beta-Cell Function. J Clin Endocrinol Metab. 2016 Nov;101(11):4076-4084. doi: 10.1210/jc.2016-2056. Epub 2016 Aug 17.
PubMed 27533307Hannon TS, Kirkman MS, Patel YR, Considine RV, Mather KJ. Profound defects in beta-cell function in screen-detected type 2 diabetes are not improved with glucose-lowering treatment in the Early Diabetes Intervention Program (EDIP). Diabetes Metab Res Rev. 2014 Nov;30(8):767-76. doi: 10.1002/dmrr.2553.
PubMed 24819707
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diabetes Intervention Program
- ClinicalTrials.gov ID
- NCT01470937
- Acronym / sponsor ID
- EDIP / 9705-34
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes acarbose alphaglucosidase prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Feb 1998
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 11 Nov 2011 (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.
This is an evaluation of the effect of acarbose to delay worsening of fasting glucose control in early Type 2 diabetes mellitus.
Detailed description
A double blind, randomized, placebo-controlled clinical trial of acarbose in subjects with type 2 diabetes (an FDA-approved indication). Subjects were identified who had diabetes by glucose tolerance test criteria but non-diabetic fasting glucose concentrations. Treatment interventions were assessed for their ability to delay worsening of fasting glucose control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acarbose | Experimental | Drug: Acarboseacarbose 100 mg once daily |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo was administered for acarbose 100 mg once daily |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fasting plasma glucose <140 mg/dL
- 75 g OGTT 2hr glucose >120 mg/dL
- BMI > 25 OR history of gestational diabetes mellitus OR family history of type 2 diabetes
- Age at least 25 years
Key exclusion criteria (9 listed)
- Cancer within 5 years
- Chronic infectious disease (HIV, Hepatitis)
- CVD event within 6 months
- Uncontrolled hypertension or requiring beta blockers or thiazide diuretics for control
- elevated AST or ALT
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 |
|---|---|---|
| AcarboseAlso: Precoseacarbose 100 mg PO once daily | Drug | Acarbose |
| Placeboacarbose placebo | Drug | Placebo |
Primary outcome
Progression of fasting glucose >140 mg/dL
Time frame: From date of randomization until the date of first documented progression or censoring, up to 5 years post randomization
Fasting plasma glucose was measured quarterly for up to 5 years. Two consecutive measures above 140 mg/dL defined progression.
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 11 Nov 2011.
- Results publication: PubMed 16936159Kirkman MS, Shankar RR, Shankar S, Shen C, Brizendine E, Baron A, McGill J. Treating postprandial hyperglycemia does not appear to delay progression of early type 2 diabetes: the Early Diabetes Intervention Program. Diabetes Care. 2006 Sep;29(9):2095-101. doi: 10.2337/dc06-0061.
- Derived from this study: PubMed 27533307Patel YR, Kirkman MS, Considine RV, Hannon TS, Mather KJ. Changes in Weight and Glucose Can Protect Against Progression in Early Diabetes Independent of Improvements in beta-Cell Function. J Clin Endocrinol Metab. 2016 Nov;101(11):4076-4084. doi: 10.1210/jc.2016-2056. Epub 2016 Aug 17.
- Derived from this study: PubMed 24819707Hannon TS, Kirkman MS, Patel YR, Considine RV, Mather KJ. Profound defects in beta-cell function in screen-detected type 2 diabetes are not improved with glucose-lowering treatment in the Early Diabetes Intervention Program (EDIP). Diabetes Metab Res Rev. 2014 Nov;30(8):767-76. doi: 10.1002/dmrr.2553.
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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.
Kieren J Mather, MD principal investigator
Indiana University
Robert V Considine, PhD principal investigator
Indiana University
Marian S Kirkman, MD study director
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acarbose in people with Type 2 Diabetes Mellitus, run by Indiana University at 1 site in United States.
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 9 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 11 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Progression of fasting glucose >140 mg/dL (time frame: From date of randomization until the date of first documented progression or censoring, up to 5 years post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01470937, which also lists 3 linked publications.
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 11 Nov 2011.