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Trial record 42 of 49 for:    diabetes type 1 AND (woman OR women OR female) AND blood glucose

Phase IV Study With a 36-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Japanese Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin.

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ClinicalTrials.gov Identifier: NCT02157298
Recruitment Status : Completed
First Posted : June 6, 2014
Results First Posted : March 17, 2016
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Dapagliflozin 5 mg
Drug: Placebo tablet

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First participant enrolled: 06-Jun-2014; Last participant last visit of ST period: 02-Feb-2015; 266 participants were enrolled in 20 Japanese centers. 183 Japanese men or women aged >=20 years with inadequate glycemic control (HbA1c levels of >=7.2% to <11.0%) with diet, exercise and on stable dose of insulin +/- DPP-4 inhibitor were treated.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A 8-week wash-out period was applicable only for participants on ongoing anti-diabetic treatment at enrollment. A 2-week lead-in period was applicable for all participants.

Reporting Groups
  Description
Dapagliflozin Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
Placebo Placebo plus insulin alone or in combination with DPP-4 inhibitor

Participant Flow:   Overall Study
    Dapagliflozin   Placebo
STARTED   123   60 
COMPLETED   119   58 
NOT COMPLETED   4   2 
Adverse Event                1                0 
Subject no longer meets study criteria                1                2 
Poor/Non-compliance                1                0 
Withdrawal by Subject                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set defined as all randomized participants (as randomized) who received at least one dose of double-blind study medication, who have a non-missing baseline value and at least one post-baseline efficacy value for at least one efficacy variable during the short-term double-blind treatment period.

Reporting Groups
  Description
Dapagliflozin Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
Placebo Placebo plus insulin alone or in combination with DPP-4 inhibitor
Total Total of all reporting groups

Baseline Measures
   Dapagliflozin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 122   60   182 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.3  (9.83)   57.6  (9.86)   58.0  (9.82) 
Age, Customized 
[Units: Participants]
     
<=65 years   84   43   127 
Between 65 and 75 years   37   16   53 
>=75 years   1   1   2 
Gender 
[Units: Participants]
     
Female   33   20   53 
Male   89   40   129 
Region of Enrollment 
[Units: Participants]
     
Japan   122   60   182 
Body Weight 
[Units: Kg]
Mean (Standard Deviation)
 73.90  (15.663)   71.89  (13.430)   73.24  (14.956) 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 26.89  (4.930)   26.12  (3.485)   26.64  (4.510) 
Waist Circumference 
[Units: Cm]
Mean (Standard Deviation)
 93.2  (11.83)   92.3  (9.00)   92.9  (10.96) 
HbA1c 
[Units: Percent of hemoglobin glycosylated]
Mean (Standard Deviation)
 8.26  (0.792)   8.52  (0.937)   8.34  (0.849) 
Fasting Plasma Glucose 
[Units: mg/dL]
Mean (Standard Deviation)
 160.70  (44.948)   159.68  (38.001)   160.36  (42.679) 
Calculated Mean Daily Insulin Dose 
[Units: IU/Day]
Mean (Standard Deviation)
 37.87  (18.033)   40.58  (16.764)   38.76  (17.625) 
DPP-4 Inhibitor Usage 
[Units: Participants]
     
Yes   54   27   81 
No   68   33   101 


  Outcome Measures

1.  Primary:   Adjusted Mean Change in HbA1c Levels   [ Time Frame: Baseline to Week 16 ]

2.  Secondary:   Fasting Plasma Glucose   [ Time Frame: Baseline to Week 16 ]

3.  Secondary:   Total Body Weight   [ Time Frame: Baseline to Week 16 ]

4.  Secondary:   Total Mean Daily Insulin Dose   [ Time Frame: Baseline to Week 16 ]

5.  Secondary:   Proportion of Participants With Mean Daily Insulin Dose Reduction of Greater Than or Equal 10%   [ Time Frame: Baseline to Week 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
For HbA1c, FPG and TBW: excluding data after insulin up-titration and for Mean Daily Insulin Dose: including data after insulin up-titration were used. For participants who did not complete week 16 last observation carried forward (LOCF) was used.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Yuji Ageishi
Organization: AstraZeneca K.K.
phone: +81-3-6268-2740
e-mail: Yuji.Ageishi@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02157298     History of Changes
Other Study ID Numbers: D1692C00013
First Submitted: June 2, 2014
First Posted: June 6, 2014
Results First Submitted: February 18, 2016
Results First Posted: March 17, 2016
Last Update Posted: May 11, 2016