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Drug to Drug Interaction Study With ASP1941 and Metformin

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01302145
Enrollment
36
Registered
2011-02-23
Start date
2009-02-25
Completion date
2009-12-09
Last updated
2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

pharmacokinetics, metformin, Drug to drug interaction, ASP1941

Brief summary

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

Interventions

DRUGPlacebo

Tablet

DRUGASP1941

Tablet

DRUGMetformin

Tablet

Sponsors

Astellas Pharma Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Safety assessed by incidence of adverse events, vital signs, 12-lead ECG and glucose monitoring5 weeks

Secondary

MeasureTime frame
Pharmacodynamics assessed by serum glucose change5 weeks
Pharmacokinetics assessed by metformin plasma concentration change5 weeks

Countries

Hungary, Netherlands, Poland, Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026