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NCT01302145 Clinical Trial

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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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