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Type 2 Diabetes MellitusPhase 1NCT01611363

A Phase 1 Study to Investigate the Mechanism of Action of Ipragliflozin

A Phase 1 study testing ASP1941 in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Europe B.V. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study the effect of ipragliflozin on glucose homeostasis in healthy subjects and T2DM subjects, and the effect of exposure of ipragliflozin on urinary glucose excretion and plasma glucose in T2DM subjects will be investigated. Read more about this study

Who is it for?
Ages 35 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
ASP1941
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteGermany
Study dates
27 Oct 2011to 3 Feb 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subject is healthy without diabetes mellitus
  • Subject has a fasted plasma glucose (FPG) of less than 5.6 mmol/l at screening
  • Subject has a Body Mass Index (BMI) more than or equal to 18.5 and less than 28.0 kg/m2
  • Subject's serum creatinine is within the normal range
  • Subject has been diagnosed with T2DM for at least 6 months
  • Subject's body mass index (BMI) is equal to or more than 20.0 and less than 35.0 kg/m2 at screening
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  • Subject has a HbA1c level above 7.0% and less than 9.0% at screening
  • Subject has a (FPG) of less than 10.0 mmol/l
  • Subject is treatment naïve to glucose-lowering medication or uses metformin that will be washed out at least 3 weeks prior to the first dosing at Day 1
  • Subject's serum creatinine is within the normal range
  • Subject has a body mass index (BMI) of more than or equal to 20.0 and less than 35.0 kg/m2 at screening.
  • Subject has been diagnosed with T2DM for at least 6 months
  • Subject has HbA1c level of equal to or more than 6.0% and less than 10% at screening
  • Subject has a FPG of less than 10.0 mmol/l
  • Subject is drug naïve or on a stable glucose lowering therapy (metformin, TZD, DPP-4 inhibitor or SUD therapy

Who cannot join

  • Any of the liver function tests above the upper limit of normal
  • A QTc interval of >430 ms (males) and >450 ms (females), a history of unexplained syncope, cardiac arrest, unexplained significant cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
  • Abnormal pulse and/or blood pressure measurements at screening as follows: Pulse <40 or >90 bpm; mean systolic blood pressure >140 mmHg; mean diastolic blood pressure >90 mmHg
  • eGFR (based on Modification of Diet in Renal Disease (MDRD) method) less than 60 ml/min/1.73m2 on Day -2
  • Subject has type 1 diabetes mellitus
  • A QTc interval of >450 ms (males) and >470 ms (females), a history of unexplained syncope, cardiac arrest, unexplained significant cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
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  • Subject is on an insulin therapy or has received insulin within 3 months prior to screening, with the exception of acute use of <7 days prior to screening
  • Subject has a urinary microalbumin/creatinine ratio above or equal to 300 mg/g at screening
  • Subject has an ALT and/or AST higher than 3 times the upper limit of normal or has a total bilirubin more than 2 times the upper limit of normal at screening
  • Subject has a symptomatic urinary tract infection or symptomatic genito-urinary infection at screening
  • Subject has persistent, uncontrolled severe hypertension as indicated by a mean systolic blood pressure > 160 mmHg or a mean diastolic blood pressure of > 100 mmHg
  • Subject has significant cardiovascular disease
  • eGFR (based on MDRD method) less than 60 ml/min/1.73m2 on Day -2

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Study site

    Neuss, 41460

Other trials in Germany

About this study

Official title: An Exploratory Study to Investigate the Effects of Ipragliflozin (ASP1941) on Glucose Homeostasis and Urinary Glucose Excretion in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus (T2DM)

In this study the effect of ipragliflozin on glucose homeostasis in healthy subjects and T2DM subjects, and the effect of exposure of ipragliflozin on urinary glucose excretion and plasma glucose in T2DM subjects will be investigated.

Read the detailed description

This study will consist of 2 parts. In Part A the effect of ipragliflozin on the glucose homeostasis will be investigated and in Part B we will investigate the effect of exposure of ipragliflozin on UGE and plasma glucose levels.

Part A

This part will be a randomized, double-blind, placebo-controlled, 2-

period, 2 treatment crossover design in healthy subjects and in T2DM

subjects who are drug naïve or washed out for metformin prior to

admission to the clinical site.

Part B

This part will be an open-label, randomized, 2-period, 2 treatment

crossover design in T2DM subjects stratified by baseline HbA1c

levels (6.0-6.9%, 7.0-7.9%, 8.0-8.9% or 9.0-9.9%).

Being tested
ASP1941, Placebo
Keywords
Ipragliflozin, Phase 1, Healthy, Diabetes Mellitus, Pharmacokinetics, Pharmacodynamics
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASP1941Drug

    Also called Ipragliflozin

    Oral

  • PlaceboDrug

    Oral

Study groups in NCT01611363
Study groupRoleWhat they receive
Part AExperimentalIpragliflozin (low dose) \& Placebo
Receives: Drug: ASP1941; Drug: Placebo
Part BExperimentalIpragliflozin (high dose)
Receives: Drug: ASP1941

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Assessment of glucose homeostasis in fasted condition and after an oral glucose load, following multiple doses of ipragliflozin in healthy subjects and subjects with T2DM

    Measured: 4 days

  2. Part A: Assessment of peripheral glucose utilization after an oral glucose load, following multiple doses of ipragliflozin

    Measured: 4 days

  3. Part A: Assessment of splanchnic uptake after an oral glucose load, following multiple doses of ipragliflozin

    Measured: 4 days

  4. Part A: Assessment of mean glucose levels in fasted condition and after an oral glucose load, following multiple doses of ipragliflozin

    Measured: 4 days

  5. Part B: Assessment of the relationship between the exposure to ipragliflozin in plasma, urinary glucose excretion and plasma glucose levels in subjects with T2DM

    Measured: 6 days (PK), 12 days (urine) and 8 days (PD)

Secondary outcomes (4)

  1. Part A: Assessment of steady state urinary sodium excretion and urinary glucose excretion following multiple doses of ipragliflozin

    Measured: 4 days (sodium) and 14 days (glucose) days

  2. Part A: Assessment of energy production and utilization of energy sources following multiple doses of ipragliflozin

    Measured: 4 days

  3. Part A: Safety and tolerability following multiple doses of ipragliflozin assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and signs and symptoms of hypoglycemia

    Measured: Up to 21 days

  4. Part B: Safety and tolerability following multiple doses of ipragliflozin assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and signs and symptoms of hypoglycemia

    Measured: Up to 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2012 (estimated)
  2. Study start27 Oct 2011
  3. Primary completion3 Feb 2012
  4. Study completion3 Feb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01611363
Sponsor's protocol ID
1941-CL-0050
Other IDs
2010-024070-19
Status last verified
Aug 2017
First submitted
31 May 2012
Last updated
22 Aug 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP1941 in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Europe B.V. at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Assessment of glucose homeostasis in fasted condition and after an oral glucose load, following multiple doses of ipragliflozin in healthy subjects and subjects with T2DM (time frame: 4 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01611363.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.

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