Phase 3
N=369
A Study In Patients With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00256867 ↗Enrolled (actual)
369
Serious AEs
1.4%
Results posted
Mar 2018
Primary outcome: Primary: Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy — -39.9; 5.4 Percent change in LDL-c — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GSK523338 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy |
-39.9; 5.4 | <0.0001 sig |
| SECONDARY Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy |
-0.01; -0.83 | <0.0001 sig |
| SECONDARY Median Percent Change From Baseline to Week 6 in LDL-c |
-32.7; -39.4; -39.0; -44.4; 5.6; 5.4 | — |
| SECONDARY Mean Change From Baseline to Week 16 in HbA1c |
-0.52; -0.54; -1.24; -1.06; -1.04; -1.31 | — |
| SECONDARY Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG) |
-0.31; -1.29; -2.10; -1.90; -1.88; -2.23 | — |
| SECONDARY Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6 |
20; 148 | <.0001 sig |
| SECONDARY Number of Participants With HbA1c < 7.0% or Reduction of HbA1c ≥ 0.7% at Week 16 |
26; 108 | <0.0001 sig |
| SECONDARY Number of Participants With FPG< 126 mg/dL (7.0 mmol/L) or Reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16 |
22; 96 | <0.0001 sig |
| SECONDARY On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate |
1; 1; 1; 0; 0; 2 | — |
| SECONDARY On-Therapy Change From Baseline in Body Weight |
0.9; -0.3; 0.0; 0.4; 0.5; 0.8 | — |
| SECONDARY Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine |
1; 0; 0; 3; 1; 2 | — |
| SECONDARY Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) |
21; 23; 22; 26; 19; 25 | — |
| SECONDARY Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline |
1; 0; 0; 4; 0; 0 | — |
Summary
This study evaluates the effect of medicines for type 2 diabetes and lipids control. This study will require about 6 office visits for lab tests and examinations. All study related medicines and medical examinations will be provided at no cost to the subjects.
Eligibility Criteria
Inclusion criteria
- A clinical diagnosis type 2 diabetes mellitus.
- Women must not be pregnant or breastfeeding during the study and 30 days after the study.
- Must sign an informed consent form at the study clinic.
Exclusion criteria
- Severe chronic diseases that would prevent from participating and completing the study by investigator's judgement.
- Use of an investigational drug within 30 days or 5 half lives before first dose of study medication.
- Insulin use for > 1 week in past 3 months.
Data sourced from ClinicalTrials.gov (NCT00256867). 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.