Phase 1
Completed N=50
Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)
Type 2 Diabetes Mellitus (T2DM)
Source: ClinicalTrials.gov NCT00704132 ↗
Enrolled (actual)
50
Serious AEs
2.0%
Results posted
May 2011
Primary outcomePrimary: Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6 — -83.9; 27.0 mg*hr/dL — p=<0.001
Summary
A clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6 |
-83.9; 27.0 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Participant has type 2 diabetes mellitus
- Males
- Females who are highly unlikely to become pregnant
- Participants poorly controlled without taking any, or taking one or two oral antidiabetic medications
Exclusion Criteria
- Participant has a history of type 1 diabetes mellitus or history of ketoacidosis
- Participant required insulin therapy within the prior 8 weeks
- Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia® (rosiglitazone) within the prior 12 weeks of the screening visit
Data sourced from ClinicalTrials.gov (NCT00704132). 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.