Phase 3
Completed N=149
A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study
Source: ClinicalTrials.gov NCT00432679 ↗Enrolled (actual)
149
Serious AEs
1.3%
Results posted
Feb 2019
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group — -0.62; 0.19 Percentage of Glycosylated Hemoglobin — p=<0.001
Summary
This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group |
-0.62; 0.19 | <0.001 sig |
| SECONDARY Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG) |
-15.9; 6.2 | <0.001 sig |
| SECONDARY Change From Baseline After 16 Weeks of Treatment in Fasting Insulin |
-0.479; -1.197 | 0.377 |
| SECONDARY Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin |
-1.64; 0.40 | 0.330 |
| SECONDARY Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) |
-0.496; -0.486 | 0.983 |
| SECONDARY Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta) |
3.776; -4.444 | 0.022 sig |
| SECONDARY Change From Baseline After 16 Weeks of Treatment in Adiponectin |
9.19; 0.98 | <0.001 sig |
| SECONDARY Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP) |
0.59; -0.07; -189.1; 699.7 | 0.069 |
| SECONDARY Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment |
44.6; 4.0; 6.8; 0.0; 44.6; 4.0 | — |
Eligibility Criteria
Inclusion criteria
- Patients with type 2 diabetes mellitus managed by SU will be candidate for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function.
Exclusion criteria
- Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.
Data sourced from ClinicalTrials.gov (NCT00432679). 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.