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Drug to Drug Interaction Study With ASP1941 and Metformin

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ASP1941
Metformin
Placebo
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring pharmacokinetics, metformin, Drug to drug interaction, ASP1941

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ASP1941 + metformin

Placebo + metformin

Arm Description

Oral

Oral

Outcomes

Primary Outcome Measures

Safety assessed by incidence of adverse events, vital signs, 12-lead ECG and glucose monitoring

Secondary Outcome Measures

Pharmacodynamics assessed by serum glucose change
Pharmacokinetics assessed by metformin plasma concentration change

Full Information

First Posted
February 21, 2011
Last Updated
July 26, 2017
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01302145
Brief Title
Drug to Drug Interaction Study With ASP1941 and Metformin
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 25, 2009 (Actual)
Primary Completion Date
December 9, 2009 (Actual)
Study Completion Date
December 9, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
pharmacokinetics, metformin, Drug to drug interaction, ASP1941

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASP1941 + metformin
Arm Type
Experimental
Arm Description
Oral
Arm Title
Placebo + metformin
Arm Type
Placebo Comparator
Arm Description
Oral
Intervention Type
Drug
Intervention Name(s)
ASP1941
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Safety assessed by incidence of adverse events, vital signs, 12-lead ECG and glucose monitoring
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Pharmacodynamics assessed by serum glucose change
Time Frame
5 weeks
Title
Pharmacokinetics assessed by metformin plasma concentration change
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
Facility Information:
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
City
Groningen
ZIP/Postal Code
9470 AE
Country
Netherlands
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
City
Bratislava
ZIP/Postal Code
83305
Country
Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
22795925
Citation
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.
Results Reference
derived
Links:
URL
https://www.astellasclinicalstudyresults.com/study.aspx?ID=5
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

Drug to Drug Interaction Study With ASP1941 and Metformin

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