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Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment

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ClinicalTrials.gov Identifier: NCT01022762
Recruitment Status : Completed
First Posted : December 1, 2009
Results First Posted : December 29, 2011
Last Update Posted : July 9, 2014
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: repaglinide
Drug: gliclazide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial was conducted at 23 sites in China.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Between screening and treatment with trial drug the participants were assessed for eligibility and were randomised to one of two treatment arms. A sub-group of 69 participants was recruited for intravenous glucose tolerance test and randomised into the repaglinide treatment group (35 participants) and gliclazide treatment group (34 participants)

Reporting Groups
  Description
Repaglinide 1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
Gliclazide 80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily

Participant Flow:   Overall Study
    Repaglinide   Gliclazide
STARTED   218   222 
Exposed to Trial Drug   217 [1]   218 [2] 
COMPLETED   196   194 
NOT COMPLETED   22   28 
Adverse Event                3                1 
Lack of Efficacy                0                1 
Protocol Violation                7                6 
Unclassified                12                20 
[1] One participant was not exposed to the treatment due to fulfillment of exclusion criteria
[2] Four participants were not exposed to the treatment due to non-compliance or lost to follow-up



  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.
No text entered.

Reporting Groups
  Description
Repaglinide 1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
Gliclazide 80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
Total Total of all reporting groups

Baseline Measures
   Repaglinide   Gliclazide   Total 
Overall Participants Analyzed 
[Units: Participants]
 217   218   435 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.1  (10.0)   53.5  (9.9)   53.8  (9.9) 
Gender 
[Units: Participants]
     
Female   107   95   202 
Male   110   123   233 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   0   0 
Not Hispanic or Latino   217   218   435 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   217   218   435 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   0   0 
White   0   0   0 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
China   217   218   435 
Height 
[Units: Cm]
Mean (Standard Deviation)
 163.2  (8.9)   163.9  (8.4)   163.5  (8.7) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 68.7  (11.6)   68.4  (11.2)   68.6  (11.4) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 25.69  (3.00)   25.37  (3.01)   25.53  (3.00) 
Duration of diagnosed diabetes 
[Units: Years]
Mean (Standard Deviation)
 1.02  (1.95)   0.79  (1.82)   0.91  (1.89) 


  Outcome Measures

1.  Primary:   Change in Glycosylated Haemoglobin (HbA1c)   [ Time Frame: Week 0, week 16 ]

2.  Secondary:   Change in Fasting Plasma Glucose   [ Time Frame: Week 0, week 16 ]

3.  Secondary:   Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal   [ Time Frame: Week 0, week 16 ]

4.  Secondary:   Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5%   [ Time Frame: Week 16 ]

5.  Secondary:   Change in Fasting Serum Free Fatty Acid (FFA) From Baseline   [ Time Frame: Week 0, week 16 ]

6.  Secondary:   Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal   [ Time Frame: Week 0, week 16 ]

7.  Secondary:   Change in AUC0-180 of Serum Insulin Concentration of IVGTT (Intravenous Glucose Tolerance Test)   [ Time Frame: Over the course of three hours at Week 0 and Week 16 ]

8.  Secondary:   Change in AUC0-180 of Plasma Glucose Concentration of IVGTT   [ Time Frame: Over the course of three hours at Week 0 and Week 16 ]

9.  Secondary:   Number of All Treatment Emergent Hypoglycaemic Episodes   [ Time Frame: Weeks 0-16 ]

10.  Secondary:   Cholesterol   [ Time Frame: Week 0, week 16 ]

11.  Secondary:   Change in Body Weight   [ Time Frame: Week 0, 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
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: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com



Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01022762     History of Changes
Other Study ID Numbers: AGEE-3783
U1111-1111-9453 ( Other Identifier: WHO )
First Submitted: November 26, 2009
First Posted: December 1, 2009
Results First Submitted: November 24, 2011
Results First Posted: December 29, 2011
Last Update Posted: July 9, 2014