Phase 3
Completed N=1,172
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)
Source: ClinicalTrials.gov NCT00094770 ↗Enrolled (actual)
1,172
Serious AEs
11.7%
Results posted
Dec 2009
Primary outcomePrimary: Change From Baseline in HbA1c at Week 52 — -0.67; -0.67 Percent
Summary
The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at Week 52 |
-0.67; -0.67 | — |
| SECONDARY Change From Baseline in HbA1c at Week 104 |
-0.54; -0.51 | — |
| SECONDARY Change From Baseline in Body Weight at Week 52 |
-1.5; 1.1 | — |
| SECONDARY Change From Baseline in Body Weight at Week 104 |
-1.6; 0.7 | — |
| SECONDARY Hypoglycemic Events at Week 52 |
29; 187; 50; 657; 559; 397 | — |
| SECONDARY Hypoglycemic Events at Week 104 |
31; 199; 57; 805; 557; 385 | — |
| SECONDARY Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104 |
452; 480; 136; 104 | — |
| SECONDARY Number of Participants With Serious CAEs at Week 104 |
64; 73; 524; 511 | — |
| SECONDARY Number of Participants With Drug-related CAEs at Week 104 |
97; 193; 491; 391 | — |
| SECONDARY Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104 |
85; 74; 503; 510 | — |
| SECONDARY Number of Participants With Serious LAEs at Week 104 |
0; 0; 588; 584 | — |
| SECONDARY Number of Participants With Drug-related LAEs at Week 104 |
18; 21 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus
Data sourced from ClinicalTrials.gov (NCT00094770). 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.