ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    AZI-P4-004
Previous Study | Return to List | Next Study

A Study to Explore the Effects of Azilsartan Compared to Telmisartan on Insulin Resistance of Patients With Essential Hypertension on Type 2 Diabetes Mellitus by HOMA-R

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02079805
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Essential Hypertension Complicated by Type 2 Diabetes Mellitus
Interventions: Drug: Azilsartan
Drug: Telmisartan

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 27 investigative sites in Japan, from 04 June 2014 to 25 April 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with diagnosis of type 2 diabetes mellitus were enrolled in 2 treatment group: Azilsartan 20 mg, and Telmisartan 40 mg for 12 weeks as treatment period.

Reporting Groups
  Description
Telmisartan 40 mg Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Azilsartan 20 mg Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.

Participant Flow:   Overall Study
    Telmisartan 40 mg   Azilsartan 20 mg
STARTED   16   17 
COMPLETED   16   15 
NOT COMPLETED   0   2 
Pretreatment Event/Adverse Event                0                1 
Voluntary Withdrawal                0                1 



  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.
Randomized Set included all randomized participants.

Reporting Groups
  Description
Telmisartan 40 mg Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Azilsartan 20 mg Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Total Total of all reporting groups

Baseline Measures
   Telmisartan 40 mg   Azilsartan 20 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   17   33 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.3  (9.10)   63.2  (12.76)   64.2  (11.02) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  56.3%      10  58.8%      19  57.6% 
Male      7  43.8%      7  41.2%      14  42.4% 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 70.95  (16.689)   70.41  (14.878)   70.67  (15.534) 
BMI [1] 
[Units: Kg/m^2]
Mean (Standard Deviation)
 27.18  (3.720)   27.19  (4.642)   27.19  (4.154) 
[1] Body Mass Index = weight (kg)/[height (m)^2]
Smoking Classification 
[Units: Participants]
     
Never smoked   8   8   16 
Current smoker   2   3   5 
Ex-smoker   6   6   12 
Alcohol Classification [1] 
[Units: Participants]
     
Yes   6   5   11 
No   10   12   22 
[1] Participants who answered Yes or No for a question "Drik Alcohol Almost Everyday?" were reported.
Duration of Hypertention 
[Units: Years]
Mean (Standard Deviation)
 4.71  (4.391)   3.54  (4.392)   4.11  (4.363) 
Duration of Diabetes Mellitus 
[Units: Years]
Mean (Standard Deviation)
 4.53  (4.279)   4.89  (5.039)   4.72  (4.617) 
Taking Biguanides [1] 
[Units: Participants]
     
Had taken   3   4   7 
Not had taken   13   13   26 
[1] Participants who had taken biguanides when study started were reported.
Insulin Resistance Index (HOMA-R) [1] 
[Units: HOMA-R Score]
Mean (Standard Deviation)
 3.31  (1.366)   4.24  (1.843)   3.79  (1.671) 
[1] Insulin Resistance Index (HOMA-R) measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance.
Blood Pressure Systolic Mean 
[Units: mmHg]
Mean (Standard Deviation)
 145.6  (9.91)   143.3  (9.28)   144.4  (9.51) 
Blood Pressure Diastolic Mean 
[Units: mmHg]
Mean (Standard Deviation)
 89.3  (10.61)   88.8  (7.19)   89.0  (8.87) 
Glycosylated Hemoglobin (HbA1c) [1] 
[Units: Percent]
Mean (Standard Deviation)
 6.63  (0.411)   6.81  (0.488)   6.72  (0.454) 
[1] Glycosylated Hemoglobin (HbA1c) were caluculated by the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound.


  Outcome Measures

1.  Primary:   Change in Insulin Resistance Index (HOMA-R) From Baseline at the End of the Treatment Period (Week 12)   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   Change in Fasting Blood Glucose From Baseline at the End of the Treatment Period (Week 12)   [ Time Frame: Baseline and Week 12 ]

3.  Secondary:   Change in Fasting Insulin From Baseline at the End of the Treatment Period (Week 12)   [ Time Frame: Baseline and Week 12 ]

4.  Secondary:   Change in Glycosylated Hemoglobin (HbA1c) From Baseline at the End of the Treatment Period (Week 12)   [ Time Frame: Baseline and Week 12 ]

5.  Secondary:   Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-β) From Baseline at the End of the Treatment Period (Week 12)   [ Time Frame: Baseline and Week 12 ]

6.  Secondary:   Change in 1,5-anhydroglucitol (1,5-AG) From Baseline at the End of the Treatment Period (Week 12)   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events   [ Time Frame: Up to Week 12 ]


  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: Medical Director
Organization: Takeda
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02079805     History of Changes
Other Study ID Numbers: 279/NRP-001
U1111-1151-7168 ( Registry Identifier: UTN (WHO) )
AZI-P4-004 ( Other Identifier: Takeda )
JapicCTI-142461 ( Registry Identifier: JapicCTI )
First Submitted: March 4, 2014
First Posted: March 6, 2014
Results First Submitted: April 24, 2017
Results First Posted: August 2, 2017
Last Update Posted: August 2, 2017