Drug to Drug Interaction Study With ASP1941 and Metformin

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Double-blind, Randomized, Placebo-controlled, Parallel Design Study, in Patients With Type 2 Diabetes Mellitus, to Investigate the Safety, Pharmacokinetics and Pharmacodynamics Interactions of Multiple Oral Doses of ASP1941 and Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302145
• Other study ID #: 1941-CL-0056
• Secondary ID: 2007-005614-39
• Status: Completed
• Phase: Phase 1
• First received: February 21, 2011
• Last updated: July 26, 2017
• Start date: February 25, 2009
• Est. completion date: December 9, 2009

Study information

• Verified date: July 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 9, 2009
• Est. primary completion date: December 9, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• ASP1941
Tablet
• Metformin
Tablet
• Placebo
Tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Hungary,  Netherlands,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by incidence of adverse events, vital signs, 12-lead ECG and glucose monitoring		5 weeks
Secondary	Pharmacodynamics assessed by serum glucose change		5 weeks
Secondary	Pharmacokinetics assessed by metformin plasma concentration change		5 weeks

External Links

•   Link to results on Astellas Clinical Study Results website