Type 2 Diabetes MellitusPhase 4NCT00686634
Sitagliptin in Combination With Metformin and Sulfonylurea
A Phase 4 study testing Sitagliptin in people with Type 2 Diabetes Mellitus, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial summary
This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in comparison to thiazolidinediones as the third-line oral agent, in patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- 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
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Mar 2010
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18-75
- Type 2 diabetes
- At least 3 months of treatment with maximum tolerated doses of metformin and a sulfonylurea agent, and inadequate glycemic control (Hemoglobin A1c (HbA1c) >7.0%)
- Able to comply with all scheduled visits and requirements of the protocol
Who cannot join
- Any contraindications to the use of metformin or a sulfonylurea agent
- Extreme hyperglycemia or symptoms of polyuria or polydipsia
- Current or previous chronic use of insulin (other than for treatment of gestational diabetes)
- History of confirmed (or clinical suspicion of) type 1 diabetes mellitus
- Episodes of symptomatic hypoglycemia averaging greater than once per day
- Estimated glomerular filtration rate (eGFR) < 60 mL/min
Show all 13Show fewer
- Subjects with active hemolytic anemias or hemoglobin variants that render the measurement of HbA1c unreliable
- History of any clinically significant hepatic, cardiovascular (including the use of digoxin), or other major systemic disease that may make the use of sitagliptin unsafe, or otherwise make the interpretation of the data difficult.
- Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception
- Current pregnancy or lactation.
- Subjects who will likely require or initiate therapy with drugs that may interfere with glucose metabolism during the course of the study.
- Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
- Subjects who are unable or unwilling to give informed consent, comply with all components of the study protocol, attend all scheduled follow-up visits, or present other barriers that would make the implementation of the protocol unusually difficult.
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles Drew University of Medicine and Science
Los Angeles, California, 90059
About this study
Official title: Sitagliptin in Combination Oral Agent Therapy for Type 2 Diabetes
This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in comparison to thiazolidinediones as the third-line oral agent, in patients with type 2 diabetes mellitus.
Read the detailed description
The aim of this protocol is to determine the non-inferiority of the effectiveness of sitagliptin compared to a control group of patients treated with thiazolidinediones as add-on therapy, in low-income ethnic minority type 2 diabetic patients who are failing to maintain adequate control with maximal doses of metformin and a sulfonylurea agent.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Sitagliptin
- Keywords
- sitagliptin, type 2 diabetes, combination therapy
- 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.
SitagliptinDrug
Also called Trade name: Januvia
Sitagliptin 100 mg by mouth once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sitagliptin 100 mg once daily Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (HbA1c) Change From Baseline
Measured: Baseline, 4 months
Secondary outcomes (3)
Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months
Measured: 4 months
Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year
Measured: 1 year
Number of Adverse Events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2010
- Study completionMar 2010
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 Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Stanley Hsia, MD, Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686634
- Sponsor's protocol ID
- 07-06-002
- Other IDs
- U54RR014616
- Status last verified
- Nov 2014
- First submitted
- 27 May 2008
- Last updated
- 26 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hsia SH, Navar MD, Duran P, Shaheen M, Davidson MB. Sitagliptin compared with thiazolidinediones as a third-line oral antihyperglycemic agent in type 2 diabetes mellitus. Endocr Pract. 2011 Sep-Oct;17(5):691-8. doi: 10.4158/EP10405.OR.
PubMed 21550951
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sitagliptin in Combination Oral Agent Therapy for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00686634
- Acronym / sponsor ID
- 07-06-002
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- sitagliptin, type 2 diabetes, combination therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Jan 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 30 May 2008 (estimated)
- Results
- Posted 26 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in comparison to thiazolidinediones as the third-line oral agent, in patients with type 2 diabetes mellitus.
Detailed description
The aim of this protocol is to determine the non-inferiority of the effectiveness of sitagliptin compared to a control group of patients treated with thiazolidinediones as add-on therapy, in low-income ethnic minority type 2 diabetic patients who are failing to maintain adequate control with maximal doses of metformin and a sulfonylurea agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SitagliptinSitagliptin 100 mg once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, age 18-75
- Type 2 diabetes
- At least 3 months of treatment with maximum tolerated doses of metformin and a sulfonylurea agent, and inadequate glycemic control (Hemoglobin A1c (HbA1c) >7.0%)
- Able to comply with all scheduled visits and requirements of the protocol
Key exclusion criteria (13 listed)
- Any contraindications to the use of metformin or a sulfonylurea agent
- Extreme hyperglycemia or symptoms of polyuria or polydipsia
- Current or previous chronic use of insulin (other than for treatment of gestational diabetes)
- History of confirmed (or clinical suspicion of) type 1 diabetes mellitus
- Episodes of symptomatic hypoglycemia averaging greater than once per day
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: Trade name: JanuviaSitagliptin 100 mg by mouth once daily | Drug | 1 |
Primary outcome
Hemoglobin A1c (HbA1c) Change From Baseline
Time frame: Baseline, 4 months
3 secondary outcomes
Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months
Time frame: 4 months
Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year
Time frame: 1 year
Number of Adverse Events
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21550951Hsia SH, Navar MD, Duran P, Shaheen M, Davidson MB. Sitagliptin compared with thiazolidinediones as a third-line oral antihyperglycemic agent in type 2 diabetes mellitus. Endocr Pract. 2011 Sep-Oct;17(5):691-8. doi: 10.4158/EP10405.OR.
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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.
Stanley Hsia, MD principal investigator
Charles Drew University of Medicine and Science
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 Sitagliptin in people with Type 2 Diabetes Mellitus, run by Charles Drew University of Medicine and Science 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 13 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 26 Nov 2014. 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?
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?
Yes. Results are posted in the registry (first posted 26 Nov 2014). 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?
Hemoglobin A1c (HbA1c) Change From Baseline (time frame: Baseline, 4 months). 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 NCT00686634, 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 26 Nov 2014.