Drug to Drug Interaction Study With ASP1941 and Metformin

Astellas

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: ASP1941; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01302145

1941-CL-0056

2007-005614-39 (EudraCT Number)

Details and patient eligibility

About

A study to investigate the effect on safety, pharmacokinetics and pharmacodynamics when ASP1941 is administered as add-on therapy to metformin.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with type 2 diabetes
• Stable disease under metformin monotherapy (between 1500-3000

mg/day) or dual therapy with metformin (1500-3000 mg/day) and a Sulfonylureum Derivative (SUD) for at least 3 months

• Fasting Serum Glucose: 7-11.5 mmol/l (after wash-out)
• Stable Fasting Blood Glucose (FBG) at the end of wash-out
• BMI between 18.5 and 40.0 kg/m2, inclusive

Exclusion criteria

• Subjects with type 1 diabetes
• Any diabetes related macro-complications, painful diabetic neuropathy, diabetic macular edema or diabetic proliferative retinopathy
• Clinical significant renal disease (CLcr <60 ml/min as assessed during a 24h creatinine clearance on Day-2
• Recent evidence (e.g. within the last 6 months) of severe hypoglycemia, for example plasma glucose <3 mmol/l (<55 mg/dl) or requiring hospitalization
• Pulse <40 or >90; Systolic Blood Pressure >160 mmHg; Diastolic Blood Pressure > 100 mmHg

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

ASP1941 + metformin

Experimental group

Description:

Oral

Treatment:

Drug: ASP1941

Drug: Metformin

Placebo + metformin

Placebo Comparator group

Description:

Oral

Treatment:

Drug: Placebo

Drug: Metformin