Trial Outcomes & Findings for 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 (NCT NCT02079805)
NCT ID: NCT02079805
Last Updated: 2017-08-02
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
33 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2017-08-02
Participant Flow
Participants took part in the study at 27 investigative sites in Japan, from 04 June 2014 to 25 April 2016.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
0
|
1
|
|
Overall Study
Voluntary Withdrawal
|
0
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Telmisartan 40 mg
n=16 Participants
Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
Azilsartan 20 mg
n=17 Participants
Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 Years
STANDARD_DEVIATION 9.10 • n=5 Participants
|
63.2 Years
STANDARD_DEVIATION 12.76 • n=7 Participants
|
64.2 Years
STANDARD_DEVIATION 11.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Weight
|
70.95 kg
STANDARD_DEVIATION 16.689 • n=5 Participants
|
70.41 kg
STANDARD_DEVIATION 14.878 • n=7 Participants
|
70.67 kg
STANDARD_DEVIATION 15.534 • n=5 Participants
|
|
BMI
|
27.18 kg/m^2
STANDARD_DEVIATION 3.720 • n=5 Participants
|
27.19 kg/m^2
STANDARD_DEVIATION 4.642 • n=7 Participants
|
27.19 kg/m^2
STANDARD_DEVIATION 4.154 • n=5 Participants
|
|
Smoking Classification
Never smoked
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Smoking Classification
Current smoker
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Smoking Classification
Ex-smoker
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Alcohol Classification
Yes
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Alcohol Classification
No
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Duration of Hypertention
|
4.71 Years
STANDARD_DEVIATION 4.391 • n=5 Participants
|
3.54 Years
STANDARD_DEVIATION 4.392 • n=7 Participants
|
4.11 Years
STANDARD_DEVIATION 4.363 • n=5 Participants
|
|
Duration of Diabetes Mellitus
|
4.53 Years
STANDARD_DEVIATION 4.279 • n=5 Participants
|
4.89 Years
STANDARD_DEVIATION 5.039 • n=7 Participants
|
4.72 Years
STANDARD_DEVIATION 4.617 • n=5 Participants
|
|
Taking Biguanides
Had taken
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Taking Biguanides
Not had taken
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Insulin Resistance Index (HOMA-R)
|
3.31 HOMA-R Score
STANDARD_DEVIATION 1.366 • n=5 Participants
|
4.24 HOMA-R Score
STANDARD_DEVIATION 1.843 • n=7 Participants
|
3.79 HOMA-R Score
STANDARD_DEVIATION 1.671 • n=5 Participants
|
|
Blood Pressure Systolic Mean
|
145.6 mmHg
STANDARD_DEVIATION 9.91 • n=5 Participants
|
143.3 mmHg
STANDARD_DEVIATION 9.28 • n=7 Participants
|
144.4 mmHg
STANDARD_DEVIATION 9.51 • n=5 Participants
|
|
Blood Pressure Diastolic Mean
|
89.3 mmHg
STANDARD_DEVIATION 10.61 • n=5 Participants
|
88.8 mmHg
STANDARD_DEVIATION 7.19 • n=7 Participants
|
89.0 mmHg
STANDARD_DEVIATION 8.87 • n=5 Participants
|
|
Glycosylated Hemoglobin (HbA1c)
|
6.63 percent
STANDARD_DEVIATION 0.411 • n=5 Participants
|
6.81 percent
STANDARD_DEVIATION 0.488 • n=7 Participants
|
6.72 percent
STANDARD_DEVIATION 0.454 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
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).
Outcome measures
| Measure |
Telmisartan 40 mg
n=16 Participants
Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
Azilsartan 20 mg
n=16 Participants
Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
|---|---|---|
|
Change in Insulin Resistance Index (HOMA-R) From Baseline at the End of the Treatment Period (Week 12)
|
-0.23 HOMA-R Score
Standard Deviation 0.928
|
0.22 HOMA-R Score
Standard Deviation 2.449
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
Change from baseline in fasting blood glucose values collected at week 12 or final visit relative to baseline was reported.
Outcome measures
| Measure |
Telmisartan 40 mg
n=16 Participants
Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
Azilsartan 20 mg
n=16 Participants
Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
|---|---|---|
|
Change in Fasting Blood Glucose From Baseline at the End of the Treatment Period (Week 12)
|
-1.06 mg/dL
Standard Deviation 14.991
|
2.00 mg/dL
Standard Deviation 18.308
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
Change from baseline in fasting insulin values collected at week 12 or final visit relative to baseline was reported.
Outcome measures
| Measure |
Telmisartan 40 mg
n=16 Participants
Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
Azilsartan 20 mg
n=16 Participants
Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
|---|---|---|
|
Change in Fasting Insulin From Baseline at the End of the Treatment Period (Week 12)
|
-0.818 µU/mL
Standard Deviation 2.7623
|
0.475 µU/mL
Standard Deviation 6.3847
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
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.
Outcome measures
| Measure |
Telmisartan 40 mg
n=16 Participants
Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
Azilsartan 20 mg
n=17 Participants
Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
|---|---|---|
|
Change in Glycosylated Hemoglobin (HbA1c) From Baseline at the End of the Treatment Period (Week 12)
|
0.10 percent
Standard Deviation 0.290
|
0.09 percent
Standard Deviation 0.382
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
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}.
Outcome measures
| Measure |
Telmisartan 40 mg
n=16 Participants
Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
Azilsartan 20 mg
n=16 Participants
Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
|---|---|---|
|
Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-β) From Baseline at the End of the Treatment Period (Week 12)
|
-3.88 percent
Standard Deviation 20.151
|
-0.44 percent
Standard Deviation 30.985
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
Change from baseline in 1,5-G concentration collected at week 12 or final visit relative to baseline was reported.
Outcome measures
| Measure |
Telmisartan 40 mg
n=16 Participants
Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
Azilsartan 20 mg
n=16 Participants
Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
|---|---|---|
|
Change in 1,5-anhydroglucitol (1,5-AG) From Baseline at the End of the Treatment Period (Week 12)
|
0.24 μg/mL
Standard Deviation 2.143
|
-0.66 μg/mL
Standard Deviation 2.454
|
SECONDARY outcome
Timeframe: Up to Week 12Population: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.
Outcome measures
| Measure |
Telmisartan 40 mg
n=16 Participants
Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
Azilsartan 20 mg
n=17 Participants
Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
|
8 participants
|
6 participants
|
Adverse Events
Telmisartan 40 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Azilsartan 20 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Telmisartan 40 mg
n=16 participants at risk
Participants received telmisartan 40 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
Azilsartan 20 mg
n=17 participants at risk
Participants received azilsartan 20 mg, once daily in the morning before or after breakfast for 12 weeks as treatment priod.
|
|---|---|---|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/16 • Up to Week 12
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.
|
5.9%
1/17 • Up to Week 12
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.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.2%
1/16 • Up to Week 12
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.
|
0.00%
0/17 • Up to Week 12
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.
|
|
General disorders
Chest discomfort
|
6.2%
1/16 • Up to Week 12
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.
|
0.00%
0/17 • Up to Week 12
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.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
2/16 • Up to Week 12
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.
|
11.8%
2/17 • Up to Week 12
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.
|
|
Infections and infestations
Bronchitis
|
6.2%
1/16 • Up to Week 12
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.
|
0.00%
0/17 • Up to Week 12
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.
|
|
Infections and infestations
Influenza
|
6.2%
1/16 • Up to Week 12
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.
|
0.00%
0/17 • Up to Week 12
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.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/16 • Up to Week 12
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.
|
5.9%
1/17 • Up to Week 12
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.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
6.2%
1/16 • Up to Week 12
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.
|
0.00%
0/17 • Up to Week 12
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Up to Week 12
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.
|
5.9%
1/17 • Up to Week 12
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.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/16 • Up to Week 12
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.
|
5.9%
1/17 • Up to Week 12
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.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
6.2%
1/16 • Up to Week 12
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.
|
0.00%
0/17 • Up to Week 12
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.
|
|
Skin and subcutaneous tissue disorders
Cutaneous amyloidosis
|
6.2%
1/16 • Up to Week 12
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.
|
0.00%
0/17 • Up to Week 12
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER