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BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Astra Zeneca, Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01498185
First received: December 21, 2011
Last updated: December 20, 2016
Last verified: December 2016
Results First Received: October 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Type 1 Diabetes Mellitus
Interventions: Drug: Dapagliflozin
Drug: Placebo matching Dapagliflozin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Of 171 participants enrolled, 76 completed a screening period. Of these 76 participants, 70 were randomized and received treatment. Of these 70 participants, 62 completed double-blind treatment period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo + Insulin Tablets, oral, once daily for 2 weeks
Dapagliflozin 1 mg + Insulin Tablets, oral, once daily for 2 weeks
Dapagliflozin 2.5 mg + Insulin Tablets, oral, once daily for 2 weeks
Dapagliflozin 5 mg + Insulin Tablets, oral, once daily for 2 weeks
Dapagliflozin 10 mg + Insulin Tablets, oral, once daily for 2 weeks

Participant Flow:   Overall Study
    Placebo + Insulin   Dapagliflozin 1 mg + Insulin   Dapagliflozin 2.5 mg + Insulin   Dapagliflozin 5 mg + Insulin   Dapagliflozin 10 mg + Insulin
STARTED   13   13   15   14   15 
COMPLETED   12   12   15   11   12 
NOT COMPLETED   1   1   0   3   3 
Adverse Event                0                0                0                1                0 
Withdrawal by Subject                1                1                0                2                1 
No longer met criteria, etc                0                0                0                0                2 



  Baseline Characteristics
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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.
All randomized participants who received at least 1 dose of study medication

Reporting Groups
  Description
Placebo + Insulin Tablets, oral, once daily for 2 weeks
Dapagliflozin 1 mg + Insulin Tablets, oral, once daily for 2 weeks
Dapagliflozin 2.5 mg + Insulin Tablets, oral, once daily for 2 weeks
Dapagliflozin 5 mg + Insulin Tablets, oral, once daily for 2 weeks
Dapagliflozin 10 mg + Insulin Tablets, oral, once daily for 2 weeks
Total Total of all reporting groups

Baseline Measures
   Placebo + Insulin   Dapagliflozin 1 mg + Insulin   Dapagliflozin 2.5 mg + Insulin   Dapagliflozin 5 mg + Insulin   Dapagliflozin 10 mg + Insulin   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   13   15   14   15   70 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.5  (12.18)   33.7  (9.11)   35.7  (13.93)   34.8  (14.00)   37.5  (15.24)   35.3  (12.86) 
Age, Customized 
[Units: Participants]
           
Younger than 45 years   10   11   11   9   10   51 
45 years and older   3   2   4   5   5   19 
Gender, Customized 
[Units: Participants]
           
Male   8   5   11   8   8   40 
Female   5   8   4   6   7   30 
Race/Ethnicity, Customized 
[Units: Participants]
           
White   11   11   14   14   12   62 
Black/African American   1   1   1   0   2   5 
Asian   0   1   0   0   0   1 
Other   1   0   0   0   1   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in 7-Point Glucose Monitoring (7-PGM) at Day 7   [ Time Frame: From Baseline to Day 7 ]

2.  Secondary:   Dapagliflozin Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: Day 7 (0 hr to 24 hr post dose) ]

3.  Secondary:   Dapagliflozin Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)   [ Time Frame: Day 7 (0 hr to 24 hr post dose) ]

4.  Secondary:   Dapagliflozin Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])   [ Time Frame: Day 7 (0 hr to 24 hr post dose) ]

5.  Secondary:   Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: Day 7 (0 hr to 24 hr post dose) ]

6.  Secondary:   Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)   [ Time Frame: Day 7 (0 hr to 24 hr post dose) ]

7.  Secondary:   Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])   [ Time Frame: Day 7 (0 hr to 24 hr post dose) ]

8.  Secondary:   Pharmacokinetic Parameters on Day 7 - Ratio of Metabolite (RM) to Parent AUC[TAU]   [ Time Frame: Day 7 (0 hr to 24 hr post dose) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Anna Maria Langkilde
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01498185     History of Changes
Other Study ID Numbers: MB102-072
Study First Received: December 21, 2011
Results First Received: October 7, 2016
Last Updated: December 20, 2016