DiabetesPhase 4NCT01100125
Sitagliptin Versus Insulin Dose Increase in Type 2 Diabetes on Insulin Treatment
A Phase 4 study testing sitagliptin and insulin dose increase in people with Diabetes, run by Seoul National University Bundang Hospital at 2 sites in South Korea.
Trial summary
It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose levels and preserves pancreatic beta cell function in patients with type 2 diabetes. DPP-IV inhibitors stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon secretion from pancreas by increasing incretin… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes
- What is being tested?
- sitagliptin and insulin dose increase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Apr 2010to Nov 2012
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- HbA1c ≥ 7%
- Age ≥ 18
- Insulin treatment with or without oral antidiabetic medication
Who cannot join
- Contraindication to sitagliptin
- Pregnant or breast feeding women
- Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
- Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT > 3-fold the upper limit of normal)
- Renal failure (Cr > 2.0)
- Cancer within 5 years
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- Not appropriate for oral antidiabetic agent
- Medication which affect glycemic control
- Disease which affect efficacy and safety of drugs
- Other clinical trial within 30 days
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Bundang Hospital
Seongnam
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Comparison Between Sitagliptin Add-on Therapy and Insulin Dose Increase Therapy for Uncontrolled Type 2 Diabetes on Insulin Therapy
It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose levels and preserves pancreatic beta cell function in patients with type 2 diabetes. DPP-IV inhibitors stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon secretion from pancreas by increasing incretin (GLP-1) levels. Recent studies reported that combination therapy with DPP-IV inhibitors and other oral antidiabetic medication have additive or synergistic effects in lowering glycose level, preserving beta-cell mass and function as well as enhancing insulin sensitivity. However, there have been few studies about the glucose lowering effect of DPP-IV inhibitors in patients with type 2 diabetes on insulin treatment.
The researchers hypothesized that DPP-IV inhibitor add-on therapy to insulin treatment may have favorable effects on glucose control and endogenous insulin secretory function in type 2 diabetic patients. The researchers plan to compare between sitagliptin (DPP-IV inhibitor) add-on therapy and insulin dose increase therapy in uncontrolled type 2 diabetes on insulin treatment.
- Conditions
- Diabetes
- Being tested
- sitagliptin, insulin dose increase
- Keywords
- Diabetes, Sitagliptin, insulin, C-peptide
- Medical subject headings
- Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sitagliptinDrug
Also called Januvia
sitagliptin 100mg once daily, orally, for 24 weeks.
insulin dose increaseDrug
Also called Long acting insulin (Lantus)
insulin dose increase
| Study group | Role | What they receive |
|---|---|---|
| sitagliptin | Experimental | Not described Receives: Drug: sitagliptin |
| insulin dose increase | Active comparator | Not described Receives: Drug: insulin dose increase |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of HbA1C
Measured: 24weeks
Secondary outcomes (5)
the number of patients in HbA1C <7% without hypoglycemia
Measured: 24 weeks
hypoglycemia(symptoms consistent with hypoglycemia and confirmed by plasma glucose < 72 mg/dL)
Measured: 24 weeks
the change of C-peptide
Measured: 24 weeks
the change of body weight and waist circumference
Measured: 24 weeks
the change of insulin dose
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100125
- Sponsor's protocol ID
- SNUBH_ENDO2
- Status last verified
- Oct 2013
- First submitted
- 5 Apr 2010
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hong ES, Khang AR, Yoon JW, Kang SM, Choi SH, Park KS, Jang HC, Shin H, Walford GA, Lim S. Comparison between sitagliptin as add-on therapy to insulin and insulin dose-increase therapy in uncontrolled Korean type 2 diabetes: CSI study. Diabetes Obes Metab. 2012 Sep;14(9):795-802. doi: 10.1111/j.1463-1326.2012.01600.x. Epub 2012 Apr 18.
PubMed 22443183
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Sitagliptin Add-on Therapy and Insulin Dose Increase Therapy for Uncontrolled Type 2 Diabetes on Insulin Therapy
- ClinicalTrials.gov ID
- NCT01100125
- Acronym / sponsor ID
- SNUBH_ENDO2
- Conditions
- Diabetes
- Keywords
- Diabetes, Sitagliptin, insulin, C-peptide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 8 Apr 2010 (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.
It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose levels and preserves pancreatic beta cell function in patients with type 2 diabetes. DPP-IV inhibitors stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon secretion from pancreas by increasing incretin (GLP-1) levels. Recent studies reported that combination therapy with DPP-IV inhibitors and other oral antidiabetic medication have additive or synergistic effects in lowering glycose level, preserving beta-cell mass and function as well as enhancing insulin sensitivity. However, there have been few studies about the glucose lowering effect of DPP-IV inhibitors in patients with type 2 diabetes on insulin treatment.
The researchers hypothesized that DPP-IV inhibitor add-on therapy to insulin treatment may have favorable effects on glucose control and endogenous insulin secretory function in type 2 diabetic patients. The researchers plan to compare between sitagliptin (DPP-IV inhibitor) add-on therapy and insulin dose increase therapy in uncontrolled type 2 diabetes on insulin treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sitagliptin | Experimental | Drug: sitagliptin |
| insulin dose increase | Active comparator | Drug: insulin dose increase |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- HbA1c ≥ 7%
- Age ≥ 18
- Insulin treatment with or without oral antidiabetic medication
Key exclusion criteria (10 listed)
- Contraindication to sitagliptin
- Pregnant or breast feeding women
- Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
- Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT > 3-fold the upper limit of normal)
- Renal failure (Cr > 2.0)
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: Januviasitagliptin 100mg once daily, orally, for 24 weeks. | Drug | sitagliptin |
| insulin dose increaseAlso: Long acting insulin (Lantus)insulin dose increase | Drug | insulin dose increase |
Primary outcome
The change of HbA1C
Time frame: 24weeks
5 secondary outcomes
the number of patients in HbA1C <7% without hypoglycemia
Time frame: 24 weeks
hypoglycemia(symptoms consistent with hypoglycemia and confirmed by plasma glucose < 72 mg/dL)
Time frame: 24 weeks
the change of C-peptide
Time frame: 24 weeks
the change of body weight and waist circumference
Time frame: 24 weeks
the change of insulin dose
Time frame: 24 weeks
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 25 Oct 2013.
- Derived from this study: PubMed 22443183Hong ES, Khang AR, Yoon JW, Kang SM, Choi SH, Park KS, Jang HC, Shin H, Walford GA, Lim S. Comparison between sitagliptin as add-on therapy to insulin and insulin dose-increase therapy in uncontrolled Korean type 2 diabetes: CSI study. Diabetes Obes Metab. 2012 Sep;14(9):795-802. doi: 10.1111/j.1463-1326.2012.01600.x. Epub 2012 Apr 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 and insulin dose increase in people with Diabetes, run by Seoul National University Bundang Hospital at 2 sites in South Korea.
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 10 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 25 Oct 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 South Korea. 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?
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?
The change of HbA1C (time frame: 24weeks). 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 NCT01100125, 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 25 Oct 2013.