Type 2 DiabetesEarly Phase 1NCT02444364
Effects of DPP-4 Inhibition on Calcium and Bone Metabolism in Type 2 Diabetes Mellitus
A Early Phase 1 study testing Sitagliptin in people with Type 2 Diabetes, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Participants will be persons with Type 2 Diabetes who are likely to have increased risk of bone fractures. The investigators believe this medication will enhance bone turnover. The investigators will use DXA measurements to evaluate bone density before and after subjects take the medication. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jan 2016
- Phase
- Early Phase 1
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus.
- Hemoglobin A1c >6.5% and <10%.
- Estimated GFR greater than 60 mL per minute per meter squared.
- Between 18 and 70 years of age.
- On oral antihyperglycemic agents with stable dose at least for last 2 months.
- Females: minimum of two years postmenopausal, surgically sterile, or using an acceptable contraceptive regimen (OCP, IUD, double barrier, Depo-Provera or subcutaneous progestin implant) and negative urine pregnancy test at trial start.
Who cannot join
- Pregnancy, breast feeding or planning pregnancy during the study period
- Any medical condition expected to be terminal within one year
- Active mental illness or other condition which in the opinion of the investigator would prevent informed consent or adherence with study protocol
- Use of any PPAR agonist within three months prior to enrollment
- Daily insulin use
- Vitamin D level < 20
Show all 11Show fewer
- Allergy or intolerance of sitagliptin or other DPP-4 inhibitor
- Use of DPP-4 inhibitor or GLP-1 analog within three months prior to enrollment
- Significant alcohol use defined as >3 standard servings of alcohol per day for men and >2 for women
- History of bariatric surgery in the last 3 years or planned bariatric surgery during the study period
- Receipt of another study drug within 30 days of screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia: Diabetes Center
Columbia, Missouri, 65212
About this study
Official title: Pilot Project Evaluation of the DPP-4 Inhibition With Sitagliptin on Calcium and Bone Metabolism in Patients With Type 2 Diabetes Mellitus
Participants will be persons with Type 2 Diabetes who are likely to have increased risk of bone fractures. The investigators believe this medication will enhance bone turnover.
The investigators will use DXA measurements to evaluate bone density before and after subjects take the medication.
Read the detailed description
Type 2 Diabetes Mellitus (T2DM) is associated with an increased risk of bone fractures even when there is not decreased bone density via DXA measurements. This appears primarily related to impaired bone quality and abnormal bone architecture. Although the exact pathophysiologic mechanisms remain unclear, low bone turnover is considered one of the key defects. Emerging evidence suggests that dipeptidyl peptidase (DPP) inhibition is associated with improved bone quality and reduction in fracture risk.
While animal studies have shown an improvement in bone mineral density and trabecular architecture with sitagliptin treatment, no such studies in humans have yet been undertaken. We are proposing to extend these animal studies with a pilot clinical trial that seeks to use serum markers of bone turn-over and calcaneal quantitative ultrasound to evaluate the effect of DPP-4 inhibition on bone metabolism. Our hypothesis is that DPP-4 inhibition with sitagliptin will enhance bone turn over and quality in persons with T2DM.
This project project seeks to examine the impact of six months of therapy on sitagliptin, a DPP-4 inhibitor, on bone metabolism and bone quality in subjects with T2DM. The proposed study is intended to be a pilot investigation for providing preliminary data for submission of a more definitive national grant proposal with a larger patient population, blinded randomized control design and high resolution CT imaging of the lumbar spine.
- Conditions
- Type 2 Diabetes
- Being tested
- Sitagliptin
- Keywords
- diabetes, bone loss, Bone Density
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia
Subjects will receive 90 tablets of 100mg sitagliptin
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Experimental | Subjects will receive 90 tablets of 100mg sitagliptin Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bone Turnover
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Funding withdrawn; no participants enrolled.
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 University of Missouri-ColumbiaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammed T Sarmini, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444364
- Sponsor's protocol ID
- MERCK-200379
- Status last verified
- May 2017
- First submitted
- 11 May 2015
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project Evaluation of the DPP-4 Inhibition With Sitagliptin on Calcium and Bone Metabolism in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02444364
- Acronym / sponsor ID
- MERCK-200379
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes, bone loss, Bone Density
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn; no participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 May 2015 (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.
Participants will be persons with Type 2 Diabetes who are likely to have increased risk of bone fractures. The investigators believe this medication will enhance bone turnover.
The investigators will use DXA measurements to evaluate bone density before and after subjects take the medication.
Detailed description
Type 2 Diabetes Mellitus (T2DM) is associated with an increased risk of bone fractures even when there is not decreased bone density via DXA measurements. This appears primarily related to impaired bone quality and abnormal bone architecture. Although the exact pathophysiologic mechanisms remain unclear, low bone turnover is considered one of the key defects. Emerging evidence suggests that dipeptidyl peptidase (DPP) inhibition is associated with improved bone quality and reduction in fracture risk.
While animal studies have shown an improvement in bone mineral density and trabecular architecture with sitagliptin treatment, no such studies in humans have yet been undertaken. We are proposing to extend these animal studies with a pilot clinical trial that seeks to use serum markers of bone turn-over and calcaneal quantitative ultrasound to evaluate the effect of DPP-4 inhibition on bone metabolism. Our hypothesis is that DPP-4 inhibition with sitagliptin will enhance bone turn over and quality in persons with T2DM.
This project project seeks to examine the impact of six months of therapy on sitagliptin, a DPP-4 inhibitor, on bone metabolism and bone quality in subjects with T2DM. The proposed study is intended to be a pilot investigation for providing preliminary data for submission of a more definitive national grant proposal with a larger patient population, blinded randomized control design and high resolution CT imaging of the lumbar spine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Experimental | Drug: SitagliptinSubjects will receive 90 tablets of 100mg sitagliptin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes mellitus.
- Hemoglobin A1c >6.5% and <10%.
- Estimated GFR greater than 60 mL per minute per meter squared.
- Between 18 and 70 years of age.
- On oral antihyperglycemic agents with stable dose at least for last 2 months.
Key exclusion criteria (11 listed)
- Pregnancy, breast feeding or planning pregnancy during the study period
- Any medical condition expected to be terminal within one year
- Active mental illness or other condition which in the opinion of the investigator would prevent informed consent or adherence with study protocol
- Use of any PPAR agonist within three months prior to enrollment
- Daily insulin use
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 |
|---|---|---|
| SitagliptinAlso: JanuviaSubjects will receive 90 tablets of 100mg sitagliptin | Drug | Sitagliptin |
Primary outcome
Change in Bone Turnover
Time frame: Six Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Muhammed T Sarmini, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sitagliptin in people with Type 2 Diabetes, run by University of Missouri-Columbia 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 6 inclusion and 11 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: withdrawn, as of the sponsor's last update on 1 Jun 2017. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Bone Turnover (time frame: Six Months). 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 Jun 2017.