Phase 1
Completed N=17
Effect of SCH 497079 on Metabolic Parameters and Influence of Race/Ethnic Origin on Therapeutic Response (Study P05338)(COMPLETED)
Source: ClinicalTrials.gov NCT00673465 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Pharmacodynamic: Change From Baseline in Mean 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States) — -4.27; 0.13; -53.8 mg/dL — p=0.5269
Summary
The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters and to determine the influence of race/ethnic origin on therapeutic response.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacodynamic: Change From Baseline in Mean 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States) |
-4.27; 0.13; -53.8 | 0.5269 |
| PRIMARY Pharmacodynamic: Change From Baseline in 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India) |
— | — |
| SECONDARY Number of Participants Who Experienced at Least One Adverse Event (Part 1 - United States) |
9; 6; 4 | — |
| SECONDARY Number of Participants Who Experienced at Least One Adverse Event (Part 2 - India) |
— | — |
| SECONDARY Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States) |
0.42; 3.22; -60.3 | 0.7410 |
| SECONDARY Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India) |
— | — |
| SECONDARY Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 1 - United States) |
-5.37; -1.78; -28.4 | 0.3146 |
| SECONDARY Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 2 - India) |
— | — |
| SECONDARY Pharmacokinetic: Mean Plasma Glucose (Over 24 Hours) at Week 4 (Part 1 - United States) |
— | — |
| SECONDARY Pharmacokinetic: Mean Plasma Glucose (Over 24 Hours) at Week 4 (Part 2 - India) |
— | — |
| SECONDARY Pharmacokinetic: Mean Maximum Observed Plasma Concentration (Cmax) (Part 1 - United States) |
— | — |
| SECONDARY Pharmacokinetic: Mean Plasma Cmax (Part 2 - India) |
— | — |
| SECONDARY Pharmacokinetic: Mean Time to Maximum Observed Plasma Concentration (Tmax) (Part 1 - United States) |
— | — |
| SECONDARY Pharmacokinetic: Mean Plasma Tmax (Part 2 - India) |
— | — |
Eligibility Criteria
Inclusion Criteria
- >=18 years of age to 65 years of age, of either sex, and having a body mass index (BMI) between 27 and 35, inclusive (USA participants)
- Clinical laboratory tests (complete blood count, blood chemistry, and urinalysis) within normal limits (excluding glucose and other changes usually associated with diabetes eg, dyslipidemia)
- Type 2 diabetes mellitus
Exclusion Criteria
- Female participants who are premenopausal or are not surgically sterilized. Participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breast-feeding.
- Participants who have received insulin therapy within 6 months, prior to Day 1/Period 1 or who require thiazide diuretics, beta-blockers and cyclic hormone therapy.
Data sourced from ClinicalTrials.gov (NCT00673465). 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.