Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of BMS-823778 in healthy Japanese subjects and Japanese patients with Type 2 Diabetes Mellitus.
Detailed description
MAD study - Multiple Ascending Dose study
Interventions
DRUGBMS-823778
Capsules, Oral, 2 mg, Once daily, 14 days
Capsules, Oral, 0 mg, Once daily, 14 days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Japanese patients with Type 2 Diabetes Mellitus (T2DM) \[Fasting glucose \< 240 mg/dL, Hemoglobin A1c (HbA1c): 6.5% to 10.0% National Glycohemoglobin Standardization Program (NGSP)\] who are treatment-naive and managed with diet and/or exercises only, ages: 20 to 65 years
Exclusion criteria
* Patient who is taking any medication for T2DM * Symptoms of poorly controlled diabetes that would preclude participation in this placebo-controlled trial * Insulin therapy within one year of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests | Up to Day 21 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trough observed plasma concentration (Cmin) of BMS-823778, as measured by plasma/urine concentration | Up to Day 21 | — |
| Time of maximum observed plasma concentration (Tmax) of BMS-823778, as measured by plasma/urine concentration | Up to Day 21 | — |
| Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-823778, as measured by plasma/urine concentration | Up to Day 21 | — |
| Accumulation Index following multiple dosing (AI) of BMS-823778, as measured by plasma/urine concentration | Up to Day 21 | — |
| Plasma half-life (T-HALF) of BMS-823778, as measured by plasma/urine concentration | Up to Day 21 | — |
| Maximum observed plasma concentration (Cmax) of BMS-823778, as measured by plasma/urine concentration | Up to Day 21 | — |
| Apparent total body clearance (CLT/F) of BMS-823778, as measured by plasma/urine concentration | Up to Day 21 | — |
| Renal clearance from plasma (CLR) of BMS-823778, as measured by plasma/urine concentration | Up to Day 21 | — |
| Peak to trough ratio (Cmax/Cmin) of BMS-823778, as measured by plasma/urine concentration | Up to Day 21 | — |
| Effective plasma half-life (T-HALFeff) of BMS-823778, as measured by plasma/urine concentration | Up to Day 21 | — |
| Pharmacodynamics, as measured by Serum concentration of cortisol and cortisone after an oral dose of cortisone and biomarkers for HPA axis activity (urinary free cortisol and cortisone, salivary cortisol, ACTH, DHEA-S and 4-androstenedione) | Up to Day 21 | * HPA = Hypothalamic-pituitary-adrenal * DHEA-S = Dehydroepiandrosterone-sulphate * ACTH = adrenocorticotropic hormone |
| Percent urinary recovery (% UR) of BMS-823778, as measured by plasma/urine concentration | Up to Day 21 | — |
Countries
Japan
Outcome results
None listed