Prediabetic StateDInT DMNCT01006018
DPP-4 Inhibition and TZD for DM Prevention
A study testing Sitagliptin + Pioglitazone in people with Prediabetic State, run by Emory University at 2 sites in United States.
Trial summary
To determine whether treatment with the diabetes medication, Januvia (sitagliptin), with or without another diabetes medicine, Actos (pioglitazone), will improve insulin secretion and insulin response individuals with Impaired Glucose Tolerance (IGT), a form of prediabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetic State
- What is being tested?
- Sitagliptin + Pioglitazone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Impaired glucose tolerance (IGT) by oral glucose tolerance test
Who cannot join
- History of diabetes mellitus
- History of congestive heart failure
- History of coronary artery disease or other macrovascular disease (stroke, peripheral vascular disease)
- History of liver disease (ALT or AST >2.5 times the upper limit of normals)
- History of renal disease (serum creatinine >1.5 mg/dl)
- History of severe osteoporosis (frequent fractures, failure on osteoporosis treatment)
Show all 9Show fewer
- Current treatment with glucocorticoids
- History of immune disorder, including HIV
- Women of child-bearing age who are pregnant, desire to become pregnant, are breastfeeding, or who refuse to take the recommended birth control measures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: DPP-4 Inhibition and Thiazolidinedione for Diabetes Mellitus Prevention (DInT DM Study)
To determine whether treatment with the diabetes medication, Januvia (sitagliptin), with or without another diabetes medicine, Actos (pioglitazone), will improve insulin secretion and insulin response individuals with Impaired Glucose Tolerance (IGT), a form of prediabetes.
- Conditions
- Prediabetic State
- Being tested
- Sitagliptin + Pioglitazone PLACEBO, Sitagliptin + Pioglitazone, PLACEBO
- Keywords
- Prediabetic State
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitagliptin + Pioglitazone PLACEBODrug
Also called Januvia (sitagliptin), Pioglitazone (Actos)
Sitagliptin 100 mg tablet daily + Pioglitazone PLACEBO 15 mg capsule daily
Sitagliptin + PioglitazoneDrug
Also called Januvia (sitaglitin), Pioglitazone (Actos)
Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily
PLACEBODrug
Also called Januvia (sitagliptin) PLACEBO, Pioglitazone (Actos) PLACEBO
Sitagliptin placebo 100 mg tablet daily + Pioglitazone placebo 15 mg capsule daily
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin + Pioglitazone PLACEBO | Experimental | Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth
+ pioglitazone PLACEBO daily by mouth Receives: Drug: Sitagliptin + Pioglitazone PLACEBO |
| Sitagliptin + Pioglitazone | Experimental | Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth
+ pioglitazone (TZD) 15 mg daily by mouth Receives: Drug: Sitagliptin + Pioglitazone |
| PLACEBO | Placebo comparator | Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth
+ pioglitazone (TZD) PLACEBO daily by mouth Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Secretion
Not measured as study was prematurely terminated due to unanticipated delays.
Measured: baseline, 6 months, 9 months (after a 3 month washout)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Unanticipated delays due to sterilization/stabilization testing of GLP-1.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- More trials run by Emory 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Dr. Mary Rhee, Emory University
- Investigators
- Mary Rhee, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006018
- Sponsor's protocol ID
- IRB00015390
- Acronym
- DInT DM
- Status last verified
- Nov 2013
- First submitted
- 27 Oct 2009
- Last updated
- 5 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.
PubMed 33210751
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DPP-4 Inhibition and Thiazolidinedione for Diabetes Mellitus Prevention (DInT DM Study)
- ClinicalTrials.gov ID
- NCT01006018
- Acronym / sponsor ID
- DInT DM / IRB00015390
- Conditions
- Prediabetic State
- Keywords
- Prediabetic State
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unanticipated delays due to sterilization/stabilization testing of GLP-1.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Posted 7 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether treatment with the diabetes medication, Januvia (sitagliptin), with or without another diabetes medicine, Actos (pioglitazone), will improve insulin secretion and insulin response individuals with Impaired Glucose Tolerance (IGT), a form of prediabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin + Pioglitazone PLACEBO | Experimental | Drug: Sitagliptin + Pioglitazone PLACEBOSitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone PLACEBO daily by mouth |
| Sitagliptin + Pioglitazone | Experimental | Drug: Sitagliptin + PioglitazoneSitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone (TZD) 15 mg daily by mouth |
| PLACEBO | Placebo comparator | Drug: PLACEBOSitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth + pioglitazone (TZD) PLACEBO daily by mouth |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Impaired glucose tolerance (IGT) by oral glucose tolerance test
Key exclusion criteria (9 listed)
- History of diabetes mellitus
- History of congestive heart failure
- History of coronary artery disease or other macrovascular disease (stroke, peripheral vascular disease)
- History of liver disease (ALT or AST >2.5 times the upper limit of normals)
- History of renal disease (serum creatinine >1.5 mg/dl)
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 |
|---|---|---|
| Sitagliptin + Pioglitazone PLACEBOAlso: Januvia (sitagliptin), Pioglitazone (Actos)Sitagliptin 100 mg tablet daily + Pioglitazone PLACEBO 15 mg capsule daily | Drug | Sitagliptin + Pioglitazone PLACEBO |
| Sitagliptin + PioglitazoneAlso: Januvia (sitaglitin), Pioglitazone (Actos)Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily | Drug | Sitagliptin + Pioglitazone |
| PLACEBOAlso: Januvia (sitagliptin) PLACEBO, Pioglitazone (Actos) PLACEBOSitagliptin placebo 100 mg tablet daily + Pioglitazone placebo 15 mg capsule daily | Drug | PLACEBO |
Primary outcome
Insulin Secretion
Time frame: baseline, 6 months, 9 months (after a 3 month washout)
Not measured as study was prematurely terminated due to unanticipated delays.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33210751Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.
Related trials for Prediabetic State
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
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.
Mary Rhee, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sitagliptin + Pioglitazone in people with Prediabetic State, run by Emory University at 2 sites 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 1 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: stopped early, as of the sponsor's last update on 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Insulin Secretion (time frame: baseline, 6 months, 9 months (after a 3 month washout)). 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 NCT01006018, which also lists 1 linked publication.
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 5 Dec 2013.