Trials Sponsors Conditions Drugs Pricing

Conditions

Essential Hypertension Complicated by Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

Change in Insulin Resistance Index (HOMA-R) From Baseline at the End of the Treatment Period (Week 12)
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).
Baseline and Week 12

Secondary Outcomes (6)

Change in Fasting Blood Glucose From Baseline at the End of the Treatment Period (Week 12)
Baseline and Week 12
Change in Fasting Insulin From Baseline at the End of the Treatment Period (Week 12)
Baseline and Week 12
Change in Glycosylated Hemoglobin (HbA1c) From Baseline at the End of the Treatment Period (Week 12)
Baseline and Week 12
Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-β) From Baseline at the End of the Treatment Period (Week 12)
Baseline and Week 12
Change in 1,5-anhydroglucitol (1,5-AG) From Baseline at the End of the Treatment Period (Week 12)
Baseline and Week 12
+1 more secondary outcomes

Study Arms (2)

Azilsartan 20 mg

EXPERIMENTAL

Participants will receive azilsartan 20 mg once daily in the morning before or after breakfast.

Drug: Azilsartan

Telmisartan 40 mg

ACTIVE COMPARATOR

Participants will receive telmisartan 40 mg once daily in the morning before or after breakfast.

Drug: Telmisartan

Interventions

AzilsartanDrug

Azilsartan tablets

Also known as: Azilva Tablets

Azilsartan 20 mg

TelmisartanDrug

Telmisartan tablets

Also known as: Micardis Tablets

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The participant was given the diagnosis of grade I or II essential hypertension and was judged by the principal investigator or investigator that they can be appropriately treated with azilsartan 20 mg and telmisartan 40 mg.
Sitting systolic blood pressure of ≥ 130 mmHg and \< 180 mmHg or sitting diastolic blood pressure of ≥ 80 mmHg and \< 110 mmHg at the start of the treatment period (Week 0) Sitting blood pressure will be measured until 2 consecutive stable measurements are obtained (i.e., the difference between 2 measurements: diastolic blood pressure of \<5 mmHg and systolic blood pressure of \< 10 mmHg) after resting in a sitting position for at least 5 minutes. The average value of the last 2 measurements will be recorded (the first the decimal place is rounded off).

Sponsors & Collaborators

Takeda
Industrylead

Study Sites (1)

Kyoto, Kyoto, Japan

Related Publications (1)

Naruse M, Koike Y, Kamei N, Sakamoto R, Yambe Y, Arimitsu M. Effects of azilsartan compared with telmisartan on insulin resistance in patients with essential hypertension and type 2 diabetes mellitus: An open-label, randomized clinical trial. PLoS One. 2019 Apr 3;14(4):e0214727. doi: 10.1371/journal.pone.0214727. eCollection 2019.
PMID: 30943275DERIVED

MeSH Terms

Interventions

azilsartanTelmisartan

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title: Medical Director
Organization: Takeda

Study Officials

General Manager
Takeda
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

33 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 6, 2014

Study Start

June 2014

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Azilsartan 20 mg

Telmisartan 40 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Azilsartan 20 mg

Telmisartan 40 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations