# A Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy

> **NCT01169090** · PHASE2 · COMPLETED · sponsor: **Kowa Research Institute, Inc.** · enrollment: 620 (estimated)

## Conditions studied

- Type 2 Diabetes

## Interventions

- **DRUG:** SK-0403
- **DRUG:** Placebo
- **DRUG:** Sitagliptin

## Key facts

- **NCT ID:** NCT01169090
- **Lead sponsor:** Kowa Research Institute, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-07
- **Primary completion:** 2011-07
- **Final completion:** 2011-08
- **Target enrollment:** 620 (ESTIMATED)
- **Last updated:** 2011-08-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01169090

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01169090, "A Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy". Retrieved via AI Analytics 2026-06-15 from https://api.ai-analytics.org/clinical/NCT01169090. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*