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NCT00541775
A Multicenter, Double-Blind, Placebo and Active Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
Phase 3 trial testing Sitagliptin in Type 2 Diabetes Mellitus in 273 participants. Completed in 1 March 2007.
1 March 2007
Quick facts
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 273 |
| Start date | 1 June 2006 |
| Primary completion | 1 March 2007 |
| Estimated completion | 1 March 2007 |
Drugs / interventions tested
- Sitagliptin (SITAGLIPTIN) — full drug profile →
- Comparator: Rosiglitazone — full drug profile →
- Comparator: Placebo — full drug profile →
- Comparator: Metformin
Conditions studied
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
Sponsor
Merck Sharp & Dohme LLC — full company profile →
Who can join
Adults 18 to 75, any sex, with Type 2 Diabetes Mellitus. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Hemoglobin A1C (A1C) at Week 18
Time frame: Baseline and 18 Weeks
A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. The study hypothesis comparison was between sitagliptin versus placebo.
Sponsor's own description
The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Comparative effectiveness of dipeptidylpeptidase-4 inhibitors in type 2 diabetes: a systematic review and mixed treatment comparison.
Craddy P, Palin HJ, Johnson KI. · · 2014 · cited 85× · PMID 24664619 · DOI 10.1007/s13300-014-0061-3 -
Systematic review and meta-analysis of efficacy and safety of combinational therapy with metformin and dipeptidyl peptidase-4 inhibitors.
Alanazi AS. · · 2015 · cited 4× · PMID 26702254 · DOI 10.1016/j.jsps.2013.12.018 -
Risk of diarrhea in patients with type 2 diabetes mellitus treated with sitagliptin: a meta-analysis of 30 randomized clinical trials.
Zhao Q, Hong D, Zheng D, Xiao Y, et al · · 2014 · cited 3× · PMID 25419118 · DOI 10.2147/dddt.s70945
Verify or expand the search:
- PubMed search for NCT00541775
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sitagliptin
Trials testing the same drug.
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- NCT06246799 — Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes · Phase 3 · recruiting
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Other recruiting trials for Type 2 Diabetes Mellitus
Currently open trials in the same condition.
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Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
- NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
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- NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
- NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00541775 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
- Last refreshed: 21 August 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00541775.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing