NCT04707508

Brief Summary

Type 2 diabetes mellitus (T2DM) is a progressive metabolic disorder in which a substantial number of patients cannot attain treatment target despite antidiabetic drugs. The renin-angiotensin system (RAS) has recently been implicated in the development of insulin resistance and impaired glucose metabolism. This study investigates the effect of adding RAS inhibitors to standard antidiabetic therapy in patients with T2DM. The primary outcome measure is the change in serum glycosylated hemoglobin A1c after 24 weeks of treatment. Secondary outcomes measures include changes in plasma lipid profile and blood pressure after treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2017

Typical duration for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

January 11, 2021

Last Update Submit

January 11, 2021

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Serum glycosylated hemoglobin A1c

    Change in serum glycosylated hemoglobin A1c of the participants

    24 weeks

Secondary Outcomes (2)

  • Plasma lipid fractions

    24 weeks

  • Blood pressure

    24 weeks

Study Arms (2)

Valsartan and metformin

EXPERIMENTAL
Drug: Valsartan 80 mg and metformin

Metformin only

ACTIVE COMPARATOR
Drug: Metformin

Interventions

Valsartan 80 mg and metforminDRUG

Valsartan 80 mg once daily in addition to metformin monotherapy

Valsartan and metformin
MetforminDRUG

Metformin monotherapy

Metformin only

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults over 21 years of age
  • clinically diagnosed type 2 diabetes mellitus
  • recipients of metformin monotherapy
  • compliance with prescriptions and dietary intervention

You may not qualify if:

  • recipients of any second-line antidiabetic drug in addition to metformin
  • recipients of any antihypertensive medication before study enrollment
  • hemoglobin disorders
  • chronic kidney disease
  • thyroid dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantou Christian Hospital

Nantou City, Nantou County, 540001, Taiwan

Location

Related Publications (5)

  • Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001.

    PMID: 32175717BACKGROUND

  • Nehme A, Zouein FA, Zayeri ZD, Zibara K. An Update on the Tissue Renin Angiotensin System and Its Role in Physiology and Pathology. J Cardiovasc Dev Dis. 2019 Mar 29;6(2):14. doi: 10.3390/jcdd6020014.

    PMID: 30934934BACKGROUND

  • Joseph JJ, Echouffo Tcheugui JB, Effoe VS, Hsueh WA, Allison MA, Golden SH. Renin-Angiotensin-Aldosterone System, Glucose Metabolism and Incident Type 2 Diabetes Mellitus: MESA. J Am Heart Assoc. 2018 Sep 4;7(17):e009890. doi: 10.1161/JAHA.118.009890.

    PMID: 30371168BACKGROUND

  • Das UN. Renin-angiotensin-aldosterone system in insulin resistance and metabolic syndrome. J Transl Int Med. 2016 Jun 1;4(2):66-72. doi: 10.1515/jtim-2016-0022. Epub 2016 Jul 7.

    PMID: 28191524BACKGROUND

  • Mor A, Aizman E, George J, Kloog Y. Ras inhibition induces insulin sensitivity and glucose uptake. PLoS One. 2011;6(6):e21712. doi: 10.1371/journal.pone.0021712. Epub 2011 Jun 29.

    PMID: 21738773BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ValsartanMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialBiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Po-Chung Cheng, MD

    Nantou Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Division of endocrine and metabolic diseases

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 13, 2021

Study Start

December 1, 2017

Primary Completion

January 23, 2019

Study Completion

November 29, 2019

Last Updated

January 13, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)