Drug to Drug Interaction Study With ASP1941 and Metformin | NCT01302145

Studies
Drug to Drug Interaction Study With ASP1941 and Metformin

NCT01302145

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Jul 28, 2017Actual

Enrollment

36Actual

Phase

Phase 1

Conditions

Type 2 Diabetes Mellitus

Interventions

ASP1941
Metformin
Placebo

Countries

Hungary
Netherlands
Poland
Slovakia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-005614-39	EudraCT Number

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2009Actual

Primary Completion Date

Dec 9, 2009Actual

Completion Date

Dec 9, 2009Actual

First Submitted Date

Feb 21, 2011

First Submission Date that Met QC Criteria

Feb 21, 2011

First Posted Date

Feb 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2017

Last Update Posted Date

Jul 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASP1941 + metformin	Experimental	Oral	Drug: ASP1941 Drug: Metformin
Placebo + metformin	Placebo Comparator	Oral	Drug: Metformin Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ASP1941	Drug	Tablet	ASP1941 + metformin
Metformin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety assessed by incidence of adverse events, vital signs, 12-lead ECG and glucose monitoring		5 weeks

Secondary Outcomes

Measure	Description	Time Frame
Pharmacodynamics assessed by serum glucose change		5 weeks
Pharmacokinetics assessed by metformin plasma concentration change		5 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Europe B.V.	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22795925	Derived	Veltkamp SA, van Dijk J, Collins C, van Bruijnsvoort M, Kadokura T, Smulders RA. Combination treatment with ipragliflozin and metformin: a randomized, double-blind, placebo-controlled study in patients with type 2 diabetes mellitus. Clin Ther. 2012 Aug;34(8):1761-71. doi: 10.1016/j.clinthera.2012.06.027. Epub 2012 Jul 15.

Facility	Status	City	State	ZIP	Country	Contacts
		Balatonfüred		8230	Hungary

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals