Japanese Phase 1 Multiple Ascending Dose Study

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: BMS-823778; Drug: Placebo matching with BMS-823778

Study type: Interventional

Funder types: Industry

Identifiers

NCT01515202

MB121-009

Details and patient eligibility

About

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.

Full description

MAD study - Multiple Ascending Dose study

Enrollment: 40 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 5 patient groups

Panel 1: BMS-823778 or Placebo matching BMS-823778

Experimental group

Description:

Healthy Subjects

Treatment:

Drug: BMS-823778

Drug: BMS-823778

Drug: Placebo matching with BMS-823778

Drug: BMS-823778

Drug: BMS-823778

Panel 2: BMS-823778 or Placebo matching BMS-823778

Experimental group

Description:

Healthy Subjects

Treatment:

Drug: BMS-823778

Drug: BMS-823778

Drug: Placebo matching with BMS-823778

Drug: BMS-823778

Drug: BMS-823778

Panel 3: BMS-823778 or Placebo matching BMS-823778

Experimental group

Description:

Healthy Subjects

Treatment:

Drug: BMS-823778

Drug: BMS-823778

Drug: Placebo matching with BMS-823778

Drug: BMS-823778

Drug: BMS-823778

Panel 4: BMS-823778 or Placebo matching BMS-823778

Experimental group

Description:

Subjects with T2DM

Treatment:

Drug: BMS-823778

Drug: BMS-823778

Drug: Placebo matching with BMS-823778

Drug: BMS-823778

Drug: BMS-823778

Panel 5: BMS-823778 or Placebo matching BMS-823778

Experimental group

Description:

Subjects with T2DM

Treatment:

Drug: BMS-823778

Drug: BMS-823778

Drug: Placebo matching with BMS-823778

Drug: BMS-823778

Drug: BMS-823778