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Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin Combined With Metformin in Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control

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ClinicalTrials.gov Identifier: NCT02104804
Recruitment Status : Completed
First Posted : April 4, 2014
Results First Posted : October 2, 2017
Last Update Posted : October 2, 2017
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: Saxagliptin 5mg
Drug: Placebo for Saxagliptin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was performed at 22 sites in the People’s Republic of China (PRC).The first patient was enrolled on 07 May 2014 and the last patient completed the study on 26 February 2016. The study was divided into a single-blind placebo lead-in period of 8 weeks, a treatment period of 24 weeks and a follow-up phase of 4 weeks.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
953 patients were enrolled, of which 641 patients took at least 1 dose of study drug and entered the lead-in period. A total of 312 patients did not enter the lead-in period (289 did not fulfill eligibility criteria, 21 due to subject decision, 1 each for severe non-compliance to protocol and other reasons) and 466 patients were randomized.

Reporting Groups
  Description
Saxagliptin Plus Insulin Saxagliptin 5 mg plus insulin
Vs. Placebo Plus Insulin Patients receiving placebo 5 mg plus insulin

Participant Flow:   Overall Study
    Saxagliptin Plus Insulin   Vs. Placebo Plus Insulin
STARTED   234 [1]   232 [1] 
COMPLETED   218 [2]   213 [3] 
NOT COMPLETED   16   19 
Did not take study medication                0                1 
Study specific discontinuation criteria                6                1 
Other listed                2                1 
Protocol Violation                0                1 
Adverse Event                4                3 
Withdrawal by Subject                4                12 
[1] Number of patients who were randomized
[2] Number of patients who completed 24 weeks of treatment
[3] Of the 19 who did not complete, 1 did not take study medication after randomization.



  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.
Note that 462 indicates the number of patients in the Full Analysis set (out of 466 randomized, 1 did not take study drug and 3 did not have 1 baseline or post baseline efficacy assessment).

Reporting Groups
  Description
Saxagliptin Plus Insulin Saxagliptin 5 mg plus insulin
Vs. Placebo Plus Insulin Patients receiving placebo 5 mg plus insulin
Total Total of all reporting groups

Baseline Measures
   Saxagliptin Plus Insulin   Vs. Placebo Plus Insulin   Total 
Overall Participants Analyzed 
[Units: Participants]
 232   230   462 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.3  (7.93)   58.9  (8.17)   59.1  (8.05) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      123  53.0%      130  56.5%      253  54.8% 
Male      109  47.0%      100  43.5%      209  45.2% 
Baseline HbA1C 
[Units: %]
Mean (Standard Deviation)
 8.52  (0.69)   8.53  (0.70)   8.53  (0.69) 
Duration of diabetes 
[Units: Years]
Mean (Standard Deviation)
 13.4  (7.28)   13.3  (6.35)   13.4  (6.83) 
Fasting Plasma Glucose (FPG) 
[Units: mg/dL]
Mean (Standard Deviation)
 167.94  (31.39)   167.34  (32.86)   167.64  (32.10) 
0-180 min Post Prandial Glucose AUC 
[Units: mg*min/dL]
Mean (Standard Deviation)
 45457.6  (8433.08)   43851.4  (9051.26)   44661.5  (8772.22) 
120-min Post Prandial Glucose 
[Units: mg/dL]
Mean (Standard Deviation)
 278.0  (58.00)   270.0  (63.30)   274.0  (60.76) 
Fasting Glucagon 
[Units: pg/dL]
Mean (Standard Deviation)
 40.007  (23.68)   40.231  (21.06)   40.119  (22.39) 
Fasting C-peptide 
[Units: ng/dL]
Mean (Standard Deviation)
 1.029  (0.52)   1.012  (0.58)   1.020  (0.55) 
Metformin use at enrolment 
[Units: Participants]
     
Yes   155   154   309 
No   77   76   153 
Mean Tolerated Daily Dose of Insulin 
[Units: Insulin Dose Units]
Mean (Standard Deviation)
 38.6  (16.49)   38.9  (14.68)   38.7  (15.60) 


  Outcome Measures

1.  Primary:   Change in HbA1c From Baseline to Week 24   [ Time Frame: Baseline to 24 weeks ]

2.  Secondary:   Change in Postprandial Glucose AUC From Baseline to Week 24 During a Meal Tolerance Test   [ Time Frame: Baseline to 24 weeks ]

3.  Secondary:   Analysis of Change in 120-minute PPG From Baseline to Week 24 During a Meal Tolerance Test   [ Time Frame: Baseline to 24 weeks ]

4.  Secondary:   Percentage of Patients Achieving a Therapeutic Glycaemic Response of HbA1c <7%   [ Time Frame: At Week 24 ]

5.  Secondary:   The Analysis of Change in Fasting Plasma Glucose From Baseline to Week 24 (This Was the Average of Weeks 20 and 24)   [ Time Frame: Baseline to Average of Weeks 20 and 24 ]

6.  Secondary:   Analysis of Change in Mean Total Daily Dose of Insulin From Baseline to Week 24   [ Time Frame: Baseline to 24 weeks ]


  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
No text entered.


  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: Eva Johnsson, MD, PhD, Global Clinical Lead
Organization: AstraZeneca
e-mail: Eva.Johnsson@astrazeneca.com


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02104804     History of Changes
Other Study ID Numbers: D1680C00010
2014L00001 ( Other Identifier: China: State Food and Drug Administration )
First Submitted: April 2, 2014
First Posted: April 4, 2014
Results First Submitted: February 24, 2017
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017