Trial · NCT01341717
Effects of Sitagliptin on Type 2 Diabetes Mellitus Patients on Treatment With Metformin and Insulin
NCT01341717, Phase 4, Completed, Jothydev's Diabetes and Research Centre
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Sitagliptin on Type 2 Diabetes Mellitus Patients on Treatment With Metformin and Insulin. Trials, record NCT01341717. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01341717
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Sitagliptin on Type 2 Diabetes Mellitus Patients on Treatment With Metformin and Insulin
- NCT number
- NCT01341717
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 440 participants, actual
- Lead sponsor
- Jothydev's Diabetes and Research Centre
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Sitagliptin, Glimepiride, Metformin, Insulin
- First posted
- 2011-04-26
- Last updated
- 2014-05-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction in HbA1c from baseline | 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%. |
| Secondary | Change in total daily dose (TDD) of insulin | 6 months | Change from baseline in insulin TDD (30-day geometric mean) at Month 6 |
| Secondary | Episodes of hypoglycemia | 6 months | Hypoglycemia (Total, severe, nocturnal) (From Month 0 to Month 6), as assessed by questionnaire and supplemented by SMBG values, if available |
| Secondary | Proportion of patients with HbA1c reduction | 6 months | Proportion of patients, who completed treatment , with HbA1c value \<6.5% \& ≤7.3% at end of study (Month 6) |
| Secondary | change in weight and BMI | 6 months | |
| Secondary | Change in both HbA1c and TDD | 6 months | Proportion of patients achieving both HbA1c ≤6.5% AND reduction in TDD (total daily dose of insulin) |
| Secondary | Change in insulin resistance and beta cell function | 6 months | Change from baseline in c-peptide levels, homeostasis model assessments of β-cell function and insulin resistance (HOMA-β and HOMA-IR) |
| Secondary | Change in lipid profile from baseline | 6 months |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01341717
GET https://conductscience.org/api/trials/v1/NCT01341717/registered