Study Details

A Study to Assess the Efficacy and Safety of Ipragliflozin in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT02794792

Astellas Study ID

The unique identification code given by the study sponsor.

1941-CL-9001

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Condition

Adult Onset Diabetes

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

18 years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

May 2016 - Jun 2017

Masking

Triple (Participant, Care Provider, Investigator)

Enrollment number

268

A Phase 3, Double-blind, Randomized Study to Assess the Efficacy and Safety of Ipragliflozin in Combination with Metformin Compared to Metformin Plus Placebo in Subjects in Russia with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site RU70009

Moscow, Russian Federation, 125315

Site RU70015

Volgograd, Russian Federation, 400001

Site RU70007

St. Petersburg, Russian Federation, 197022

Site RU70011

Moscow, Russian Federation, 117036

Site RU70005

Moscow, Russian Federation, 119034

Site RU70003

Moscow, Russian Federation, 121374

Site RU70002

St. Petersburg, Russian Federation, 197706

Site RU70006

Samara, Russian Federation, 443067

Site RU70001

Yaroslavl, Russian Federation, 150003

Site RU70013

Yaroslavl, Russian Federation, 150062

Site RU70010

Nizhniy Novgorod, Russian Federation, 603018

Site RU70004

Saratov, Russian Federation, 410012

Site RU70014

St. Petersburg, Russian Federation, 194354

Site RU70008

St. Petersburg, Russian Federation, 191119