Diabetes Mellitus, Type 2Phase 4NCT01341717
Effects of Sitagliptin on Type 2 Diabetes Mellitus Patients on Treatment With Metformin and Insulin
A Phase 4 study testing Sitagliptin, Glimepiride and Metformin in people with Diabetes Mellitus, Type 2, run by Jothydev's Diabetes and Research Centre at 1 site in India.
Trial summary
The purpose of the study is to determine the efficacy and safety of sitaglipin in the treatment of Type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control using metformin and insulin. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Sitagliptin, Glimepiride and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2012to May 2014
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- T2DM patients on metformin and biphasic or basal regimens of insulin
- HbA1c ≥7.3% to ≤8.5%
- Age: 25 to 60 yrs
- Insulin TDD > 10 IU
Who cannot join
- Use of acarbose, pioglitazone or short-acting insulin analogues at time of run-in phase
- History of type 1 diabetes mellitus
- Creatinine clearance ≤50 mL/min
- Chronic liver \& kidney diseases, SGOT/PT≥2.5x upper limit of normal, uncontrolled thyroid disorders , cardiac failure, hemochromatosis, autoimmune disorders, corticosteroid intake.
- BMI >40 kg/m2
Trial locations and contacts
1 site in 1 country.
India1 site
Jothydev's Diabetes and Research Center
Thiruvananthapuram, Kerala, 695032
About this study
Official title: Open-labelled, Randomized, Active-controlled, Parallel-arm, Single-center Study on Effect of Sitagliptin on T2DM Patients on Treatment With Metformin and Insulin
The purpose of the study is to determine the efficacy and safety of sitaglipin in the treatment of Type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control using metformin and insulin.
Read the detailed description
DPP-4 inhibitors enhance function of endogenous incretin that helps with glucose homoeostasis. DPP-4 inhibitors have been proved to promote glycemic control without increasing risk of hypoglycemia and weight gain. In addition, they may improve beta-cell function and do not have any known associations with overt cardiovascular or hepatic safety risks.
Addition of sitagliptin to treatment of T2DM patients poorly controlled on insulin +/- metformin has been shown to reduce HbA1c while being generally well-tolerated.
It could be clinically useful to add sitaglipin to treatment regimen of T2DM patients on stable therapy with insulin \& metformin. Apart from glycemic reduction, secondary effects like prevention of weight gain, reduction in insulin dose, improved cardiovascular risk profile, etc. may be expected from addition of sitagliptin to treatment.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Sitagliptin, Glimepiride, Metformin, Insulin
- Keywords
- Diabetes Mellitus, Type 2, Sitagliptin, Insulin
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
100 mg once daily for 6 months
GlimepirideDrug
1 mg/2 mg/3 mg once daily
MetforminDrug
>=1000 mg twice daily
InsulinDrug
TDD > 10 IU once/twice daily
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin along with metformin and insulin | Experimental | Not described Receives: Drug: Sitagliptin; Drug: Glimepiride; Drug: Metformin; Drug: Insulin |
| Glimepiride as an active comparator to Sitagliptin | Active comparator | Not described Receives: Drug: Sitagliptin; Drug: Glimepiride; Drug: Metformin; Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in HbA1c from baseline
To confirm the efficacy of metformin+ insulin+ sitagliptin in controlling glycemia with respect to change from baseline in HbA1c after 24 weeks of administration. This will be accomplished by comparing the difference in change from baseline in HbA1c after 24 weeks of administration, compared with metformin+insulin+glimepiride to a non-inferiority limit of 0.3% , and if non-inferiority is proven, to a superiority limit of 0%.
Measured: six months
Secondary outcomes (7)
Change in total daily dose (TDD) of insulin
Change from baseline in insulin TDD (30-day geometric mean) at Month 6
Measured: 6 months
Episodes of hypoglycemia
Hypoglycemia (Total, severe, nocturnal) (From Month 0 to Month 6), as assessed by questionnaire and supplemented by SMBG values, if available
Measured: 6 months
Proportion of patients with HbA1c reduction
Proportion of patients, who completed treatment , with HbA1c value <6.5% \& ≤7.3% at end of study (Month 6)
Measured: 6 months
change in weight and BMI
Measured: 6 months
Change in both HbA1c and TDD
Proportion of patients achieving both HbA1c ≤6.5% AND reduction in TDD (total daily dose of insulin)
Measured: 6 months
Change in insulin resistance and beta cell function
Change from baseline in c-peptide levels, homeostasis model assessments of β-cell function and insulin resistance (HOMA-β and HOMA-IR)
Measured: 6 months
Change in lipid profile from baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study startFeb 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jothydev's Diabetes and Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jothydev Kesavadev, MD, Principal investigator, Jothydev's Diabetes and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341717
- Sponsor's protocol ID
- JDC/SITA/021/2011
- Status last verified
- May 2014
- First submitted
- 23 Apr 2011
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-labelled, Randomized, Active-controlled, Parallel-arm, Single-center Study on Effect of Sitagliptin on T2DM Patients on Treatment With Metformin and Insulin
- ClinicalTrials.gov ID
- NCT01341717
- Acronym / sponsor ID
- JDC/SITA/021/2011
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Sitagliptin, Insulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Jothydev's Diabetes and Research CentreUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 Apr 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.
The purpose of the study is to determine the efficacy and safety of sitaglipin in the treatment of Type 2 diabetes mellitus (T2DM) patients with inadequate glycemic control using metformin and insulin.
Detailed description
DPP-4 inhibitors enhance function of endogenous incretin that helps with glucose homoeostasis. DPP-4 inhibitors have been proved to promote glycemic control without increasing risk of hypoglycemia and weight gain. In addition, they may improve beta-cell function and do not have any known associations with overt cardiovascular or hepatic safety risks.
Addition of sitagliptin to treatment of T2DM patients poorly controlled on insulin +/- metformin has been shown to reduce HbA1c while being generally well-tolerated.
It could be clinically useful to add sitaglipin to treatment regimen of T2DM patients on stable therapy with insulin \& metformin. Apart from glycemic reduction, secondary effects like prevention of weight gain, reduction in insulin dose, improved cardiovascular risk profile, etc. may be expected from addition of sitagliptin to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin along with metformin and insulin | Experimental | Drug: Sitagliptin, Drug: Glimepiride, Drug: Metformin, Drug: Insulin |
| Glimepiride as an active comparator to Sitagliptin | Active comparator | Drug: Sitagliptin, Drug: Glimepiride, Drug: Metformin, Drug: Insulin |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- T2DM patients on metformin and biphasic or basal regimens of insulin
- HbA1c ≥7.3% to ≤8.5%
- Age: 25 to 60 yrs
- Insulin TDD > 10 IU
Key exclusion criteria (5 listed)
- Use of acarbose, pioglitazone or short-acting insulin analogues at time of run-in phase
- History of type 1 diabetes mellitus
- Creatinine clearance ≤50 mL/min
- Chronic liver \& kidney diseases, SGOT/PT≥2.5x upper limit of normal, uncontrolled thyroid disorders , cardiac failure, hemochromatosis, autoimmune disorders, corticosteroid intake.
- BMI >40 kg/m2
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 |
|---|---|---|
| Sitagliptin100 mg once daily for 6 months | Drug | Glimepiride as an active comparator to Sitagliptin, Sitagliptin along with metformin and insulin |
| Glimepiride1 mg/2 mg/3 mg once daily | Drug | Glimepiride as an active comparator to Sitagliptin, Sitagliptin along with metformin and insulin |
| Metformin>=1000 mg twice daily | Drug | Glimepiride as an active comparator to Sitagliptin, Sitagliptin along with metformin and insulin |
| InsulinTDD > 10 IU once/twice daily | Drug | Glimepiride as an active comparator to Sitagliptin, Sitagliptin along with metformin and insulin |
Primary outcome
Reduction in HbA1c from baseline
Time frame: six months
To confirm the efficacy of metformin+ insulin+ sitagliptin in controlling glycemia with respect to change from baseline in HbA1c after 24 weeks of administration. This will be accomplished by comparing the difference in change from baseline in HbA1c after 24 weeks of administration, compared with metformin+insulin+glimepiride to a non-inferiority limit of 0.3% , and if non-inferiority is proven, to a superiority limit of 0%.
7 secondary outcomes
Change in total daily dose (TDD) of insulin
Time frame: 6 months
Episodes of hypoglycemia
Time frame: 6 months
Proportion of patients with HbA1c reduction
Time frame: 6 months
change in weight and BMI
Time frame: 6 months
Change in both HbA1c and TDD
Time frame: 6 months
Change in insulin resistance and beta cell function
Time frame: 6 months
Change in lipid profile from baseline
Time frame: 6 months
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 30 May 2014.
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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.
Jothydev Kesavadev, MD principal investigator
Jothydev's Diabetes and Research Center
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, Glimepiride and Metformin in people with Diabetes Mellitus, Type 2, run by Jothydev's Diabetes and Research Centre at 1 site in India.
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 5 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 30 May 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 India. 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?
Reduction in HbA1c from baseline (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 30 May 2014.