NCT01302145

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Feb 2009

Typical duration for phase_1 type-2-diabetes-mellitus

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

10 months

First QC Date

February 21, 2011

Last Update Submit

July 26, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

pharmacokineticsmetforminDrug to drug interactionASP1941

Outcome Measures

Primary Outcomes (1)

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

    5 weeks

Secondary Outcomes (2)

  • Pharmacodynamics assessed by serum glucose change

    5 weeks

  • Pharmacokinetics assessed by metformin plasma concentration change

    5 weeks

Study Arms (2)

ASP1941 + metformin

EXPERIMENTAL

Oral

Drug: ASP1941Drug: Metformin

Placebo + metformin

PLACEBO COMPARATOR

Oral

Drug: MetforminDrug: Placebo

Interventions

ASP1941DRUG

Tablet

ASP1941 + metformin
MetforminDRUG

Tablet

ASP1941 + metforminPlacebo + metformin
PlaceboDRUG

Tablet

Placebo + metformin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Balatonfüred, 8230, Hungary

Location

Unknown Facility

Budapest, 1083, Hungary

Location

Unknown Facility

Groningen, 9470 AE, Netherlands

Location

Unknown Facility

Warsaw, 02-097, Poland

Location

Unknown Facility

Bratislava, 83305, Slovakia

Location

Related Publications (1)

  • 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.

    PMID: 22795925DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ipragliflozinMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Use Central Contact

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2011

First Posted

February 23, 2011

Study Start

February 25, 2009

Primary Completion

December 9, 2009

Study Completion

December 9, 2009

Last Updated

July 28, 2017

Record last verified: 2017-07

Locations

NL(1)SL(1)PL(1)HU(2)