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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

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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
Enrollment 33
Recruitment Details Participants took part in the study at 27 investigative sites in Japan, from 04 June 2014 to 25 April 2016.
Pre-assignment Details 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.
Arm/Group Title Telmisartan 40 mg Azilsartan 20 mg
Hide Arm/Group Description Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod. Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Period Title: Overall Study
Started 16 17
Completed 16 15
Not Completed 0 2
Reason Not Completed
Pretreatment Event/Adverse Event             0             1
Voluntary Withdrawal             0             1
Arm/Group Title Telmisartan 40 mg Azilsartan 20 mg Total
Hide Arm/Group Description Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod. Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod. Total of all reporting groups
Overall Number of Baseline Participants 16 17 33
Hide Baseline Analysis Population Description
Randomized Set included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 17 participants 33 participants
65.3  (9.10) 63.2  (12.76) 64.2  (11.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Female
9
  56.3%
10
  58.8%
19
  57.6%
Male
7
  43.8%
7
  41.2%
14
  42.4%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 16 participants 17 participants 33 participants
70.95  (16.689) 70.41  (14.878) 70.67  (15.534)
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 16 participants 17 participants 33 participants
27.18  (3.720) 27.19  (4.642) 27.19  (4.154)
[1]
Measure Description: Body Mass Index = weight (kg)/[height (m)^2]
Smoking Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Never smoked 8 8 16
Current smoker 2 3 5
Ex-smoker 6 6 12
Alcohol Classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Yes 6 5 11
No 10 12 22
[1]
Measure Description: Participants who answered Yes or No for a question "Drik Alcohol Almost Everyday?" were reported.
Duration of Hypertention  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 17 participants 33 participants
4.71  (4.391) 3.54  (4.392) 4.11  (4.363)
Duration of Diabetes Mellitus  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 17 participants 33 participants
4.53  (4.279) 4.89  (5.039) 4.72  (4.617)
Taking Biguanides   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 33 participants
Had taken 3 4 7
Not had taken 13 13 26
[1]
Measure Description: Participants who had taken biguanides when study started were reported.
Insulin Resistance Index (HOMA-R)   [1] 
Mean (Standard Deviation)
Unit of measure:  HOMA-R Score
Number Analyzed 16 participants 17 participants 33 participants
3.31  (1.366) 4.24  (1.843) 3.79  (1.671)
[1]
Measure Description: 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  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 16 participants 17 participants 33 participants
145.6  (9.91) 143.3  (9.28) 144.4  (9.51)
Blood Pressure Diastolic Mean  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 16 participants 17 participants 33 participants
89.3  (10.61) 88.8  (7.19) 89.0  (8.87)
Glycosylated Hemoglobin (HbA1c)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 16 participants 17 participants 33 participants
6.63  (0.411) 6.81  (0.488) 6.72  (0.454)
[1]
Measure Description: Glycosylated Hemoglobin (HbA1c) were caluculated by the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound.
1.Primary Outcome
Title Change in Insulin Resistance Index (HOMA-R) From Baseline at the End of the Treatment Period (Week 12)
Hide Description Change from the start of the treatment period (baseline) at the end of the treatment period (Week 12) was reported. 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
Arm/Group Title Telmisartan 40 mg Azilsartan 20 mg
Hide Arm/Group Description:
Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: HOMA-R Score
-0.23  (0.928) 0.22  (2.449)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40 mg, Azilsartan 20 mg
Comments Telmisartan 40 mg, Azilsartan 20 mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.44
Confidence Interval (2-Sided) 95%
-0.89 to 1.78
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Fasting Blood Glucose From Baseline at the End of the Treatment Period (Week 12)
Hide Description Change from baseline in fasting blood glucose values collected at week 12 or final visit relative to baseline was reported.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
Arm/Group Title Telmisartan 40 mg Azilsartan 20 mg
Hide Arm/Group Description:
Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: mg/dL
-1.06  (14.991) 2.00  (18.308)
3.Secondary Outcome
Title Change in Fasting Insulin From Baseline at the End of the Treatment Period (Week 12)
Hide Description Change from baseline in fasting insulin values collected at week 12 or final visit relative to baseline was reported.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
Arm/Group Title Telmisartan 40 mg Azilsartan 20 mg
Hide Arm/Group Description:
Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: µU/mL
-0.818  (2.7623) 0.475  (6.3847)
4.Secondary Outcome
Title Change in Glycosylated Hemoglobin (HbA1c) From Baseline at the End of the Treatment Period (Week 12)
Hide Description Change from baseline in the values of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline was reported.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
Arm/Group Title Telmisartan 40 mg Azilsartan 20 mg
Hide Arm/Group Description:
Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: percent
0.10  (0.290) 0.09  (0.382)
5.Secondary Outcome
Title Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-β) From Baseline at the End of the Treatment Period (Week 12)
Hide Description Change from baseline in HOMA-β collected at week 12 or final visit relative to baseline was reported. Homeostasis model assessment of beta cell function measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
Arm/Group Title Telmisartan 40 mg Azilsartan 20 mg
Hide Arm/Group Description:
Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: percent
-3.88  (20.151) -0.44  (30.985)
6.Secondary Outcome
Title Change in 1,5-anhydroglucitol (1,5-AG) From Baseline at the End of the Treatment Period (Week 12)
Hide Description Change from baseline in 1,5-G concentration collected at week 12 or final visit relative to baseline was reported.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
Arm/Group Title Telmisartan 40 mg Azilsartan 20 mg
Hide Arm/Group Description:
Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: μg/mL
0.24  (2.143) -0.66  (2.454)
7.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events
Hide Description [Not Specified]
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
Arm/Group Title Telmisartan 40 mg Azilsartan 20 mg
Hide Arm/Group Description:
Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
Overall Number of Participants Analyzed 16 17
Measure Type: Number
Unit of Measure: participants
8 6
Time Frame Up to Week 12
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Telmisartan 40 mg Azilsartan 20 mg
Hide Arm/Group Description Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod. Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
All-Cause Mortality
Telmisartan 40 mg Azilsartan 20 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telmisartan 40 mg Azilsartan 20 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telmisartan 40 mg Azilsartan 20 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   8/16 (50.00%)   6/17 (35.29%) 
Eye disorders     
Diabetic retinopathy  1  0/16 (0.00%)  1/17 (5.88%) 
Gastrointestinal disorders     
Abdominal pain lower  1  1/16 (6.25%)  0/17 (0.00%) 
General disorders     
Chest discomfort  1  1/16 (6.25%)  0/17 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  2/16 (12.50%)  2/17 (11.76%) 
Bronchitis  1  1/16 (6.25%)  0/17 (0.00%) 
Influenza  1  1/16 (6.25%)  0/17 (0.00%) 
Investigations     
Blood pressure decreased  1  0/16 (0.00%)  1/17 (5.88%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  1/16 (6.25%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/16 (6.25%)  1/17 (5.88%) 
Spinal osteoarthritis  1  0/16 (0.00%)  1/17 (5.88%) 
Reproductive system and breast disorders     
Vaginal haemorrhage  1  1/16 (6.25%)  0/17 (0.00%) 
Skin and subcutaneous tissue disorders     
Cutaneous amyloidosis  1  1/16 (6.25%)  0/17 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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 first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
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