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

NCT02079805 | Completed Phase 4 Results

• 4 other identifiers: 279/NRP-001U1111-1151-7168AZI-P4-004JapicCTI-142461
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Multicenter, randomized, open-label, parallel-group exploratory study to explore the effects of azilsartan (Azirva), compared with telmisartan, on insulin resistance in participants with essential hypertension complicated by type 2 diabetes mellitus

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

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

Azilsartan DRUG

Azilsartan tablets

Also known as: Azilva Tablets

Azilsartan 20 mg

Telmisartan DRUG

Telmisartan tablets

Also known as: Micardis Tablets

Telmisartan 40 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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).
• Type 2 diabetes mellitus
• HbA1c (NGSP (National Glycohemoglobin Standardization Program) value) of \< 8.4% during 3 months before informed consent, with a ≤ 0.3% change in HbA1c (peak minus nadir) during 3 months before informed consent
• No change in diet/exercise therapy during the 3 months before the informed consent in a participant who has been on diet/exercise therapy and instructed to improve life style (e.g., diet and exercise)
• Age ≥ 20 years at the time of consent
• Outpatients
• Capable of providing written consent before participation in this study.

You may not qualify if:

• Grade III essential hypertension (i.e., sitting systolic blood pressure 180 mmHg or sitting diastolic blood pressure ≥ 110 mmHg), secondary hypertension, or malignant hypertension.
• Grade II essential hypertension (i.e., sitting systolic blood pressure ≥ 160 mmHg or sitting diastolic blood pressure ≥ 100 mmHg) for which antihypertensive drug(s) are used
• Use of oral antihypertensive medication within 2 weeks before the start of the treatment period Participants who are on any antihypertensive agent at the time of informed consent can be enrolled in the study only after 2-week washout following informed consent.
• Use of RAS inhibitors or thiazolidines within 3 months before the start of the treatment period
• Type 1 diabetes mellitus
• Fasting blood glucose of \< 180 mg/dL and HOMA-R of ≤ 1.6 at the start of the treatment period (Week 0)
• Receiving or requiring any of the following at the time of informed consent:
• Insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, or other parenteral hypoglycemic agents
• Combination therapy with 3 or more oral hypoglycemic agents
• Change of antidiabetic medication (including dosage change) within 3 months before the start of the treatment period
• Having diagnosed/treated any of the following cardiovascular diseases within 3 months before the start of the treatment period:
• Cardiac disease/condition: myocardial infarction, coronary revascularization procedure
• Cerebrovascular disease: cerebral infarction, cerebral haemorrhage, transient ischaemic attack
• Advanced hypertensive retinopathy (retinal bleeding or oozing, papilloedema)
• Having diagnosed/treated for any of the following cardiovascular diseases more than 3 months before the start of the treatment period, and is now still in unstable condition.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Kyoto, Kyoto, Japan

Location

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: 30943275 DERIVED

MeSH Terms

Interventions

azilsartan; Telmisartan

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• General Manager

  Takeda

  STUDY DIRECTOR

Publication Agreements

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

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 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 2, 2017
• Results First Posted: August 2, 2017

Record last verified: 2017-04

Locations

JP (1)