Phase 3
Completed N=190
Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM)
Source: ClinicalTrials.gov NCT00337610 ↗
Enrolled (actual)
190
Serious AEs
2.6%
Results posted
May 2010
Primary outcomePrimary: Change From Baseline in A1C at Week 18 — -1.00; 0.02 Percent — p=<0.001
Summary
A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in A1C at Week 18 |
-1.00; 0.02 | <0.001 sig |
| SECONDARY Change From Baseline in FPG at Week 18 |
-32.0; -6.5 | <0.001 sig |
| SECONDARY Change From Baseline in 2 Hr-PMG at Week 18 |
-67.6; -13.5 | <0.001 sig |
| SECONDARY Change From Baseline in A1C at Week 30 |
-0.98; 0.04 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Patient has type 2 diabetes mellitus
- Males
- Females who are highly unlikely to become pregnant
- Patients poorly controlled while taking one or two oral antidiabetic medications
Exclusion Criteria
- Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
- Patient required insulin therapy within the prior 8 weeks
- Patient is on or has been taking Thiazolidinediones (TZDs) such as Actos® (pioglitazone) or Avandia® (rosiglitazone) or is on or has been taking Byetta® (exenatide) within the prior 12 weeks of the screening visit
Data sourced from ClinicalTrials.gov (NCT00337610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.