Phase 2
Completed N=367
A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator
Source: ClinicalTrials.gov NCT00631007 ↗Enrolled (actual)
367
Serious AEs
3.3%
Results posted
Sep 2010
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward — -0.3; -0.6; -0.9; -1.0 Percernt
Summary
This is a 24 week study comparing the efficacy of four dose levels of INT131 besylate with pioglitazone HCl in patients with type 2 diabetes. Eligible patients will be men and women (of non-childbearing potential or using dual barrier methods of contraception) between 30 and 75 years of age who are minimally responsive to treatment with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward |
-0.3; -0.6; -0.9; -1.0; -0.9; -0.1 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward. |
-0.3; -14.6; -28.9; -26.9; -33.2; 4.6 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Type 2 diabetes and on either sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 3 months at stable dose
- Males and Females (of non-childbearing potential or who are using dual barrier methods of contraception) between 30 and 75 years of age
- HbA1c must be ≥7.5% and ≤10% at screening
- Fasting Plasma Glucose must be 45 kg/m2
- Fasting triglycerides >500 mg/dL
- Uncontrolled hypertension (sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >100 mmHg
- Presence of diabetic complications, which in the opinion of the investigator, would complicate the subject's participation in the study (i.e., require initiation of new medication)
Data sourced from ClinicalTrials.gov (NCT00631007). 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.