NCT02312063

Brief Summary

In a prospective, randomized case-controlled study, the investigators hope to demonstrate a positive correlation of plasma levels of EPA and DHA as well as fish intake with the HbA1c-lowering effect of sitagliptin but not with the active comparator glimepiride.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

December 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

July 1, 2019

Completed
Last Updated

July 1, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

December 4, 2014

Results QC Date

June 25, 2018

Last Update Submit

April 4, 2019

Conditions

Diabetes Mellitus, Type 2

Keywords

DPP-4 inhibitorsulfonylurea

Outcome Measures

Primary Outcomes (1)

  • Correlation of Plasma Levels of EPA and DHA With HbA1c Reduction

    Pearson's correlation coefficient of HbA1c reduction with plasma levels of EPA and DHA at baseline

    0-16 weeks

Secondary Outcomes (1)

  • Correlation of Estimated Seafood Intake With HbA1c Reduction

    0-16 weeks

Study Arms (2)

Sitagliptin

EXPERIMENTAL

Sitagliptin 50 mg a day for 16 weeks

Drug: Sitagliptin

Glimepiride

ACTIVE COMPARATOR

Glimepiride 0.5 mg a day for 16 weeks

Drug: Glimepiride

Interventions

SitagliptinDRUG
Also known as: Januvia
Sitagliptin
GlimepirideDRUG
Also known as: Amaryl
Glimepiride

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Japanese T2DM patients, who are OAD naïve or receive 4-week wash out of one OAD (glinides, alpha-GI, metformin) before randomization.
  • HbA1c:6.0-8.0 %
  • BMI:18-30 kg/m2
  • Age:20-75 years old
  • CrCl: \> 60mL/min

You may not qualify if:

  • Patients on DPP-4 inhibitors or glimepiride
  • Patients treated with pioglitazone
  • Patients with moderate/severe renal impairments
  • Patients with insulin or GLP-1 receptor agonists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saiseikai Noe Hospital Osaka

Osaka, 536-0001, Japan

Location

Kansai Electric Power Hospital

Osaka, 553-0003, Japan

Location

Related Publications (4)

  • Park H, Park C, Kim Y, Rascati KL. Efficacy and safety of dipeptidyl peptidase-4 inhibitors in type 2 diabetes: meta-analysis. Ann Pharmacother. 2012 Nov;46(11):1453-69. doi: 10.1345/aph.1R041. Epub 2012 Nov 7.

    PMID: 23136353BACKGROUND

  • Kim YG, Hahn S, Oh TJ, Kwak SH, Park KS, Cho YM. Differences in the glucose-lowering efficacy of dipeptidyl peptidase-4 inhibitors between Asians and non-Asians: a systematic review and meta-analysis. Diabetologia. 2013 Apr;56(4):696-708. doi: 10.1007/s00125-012-2827-3. Epub 2013 Jan 24.

    PMID: 23344728BACKGROUND

  • Iwasaki M, Hoshian F, Tsuji T, Hirose N, Matsumoto T, Kitatani N, Sugawara K, Usui R, Kuwata H, Sugizaki K, Kitamoto Y, Fujiwara S, Watanabe K, Hyo T, Kurose T, Seino Y, Yabe D. Predicting efficacy of dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes: Association of glycated hemoglobin reduction with serum eicosapentaenoic acid and docosahexaenoic acid levels. J Diabetes Investig. 2012 Oct 18;3(5):464-7. doi: 10.1111/j.2040-1124.2012.00214.x.

    PMID: 24843607BACKGROUND

  • Senmaru T, Fukui M, Kobayashi K, Iwase H, Inada S, Okada H, Asano M, Yamazaki M, Hasegawa G, Nakamura N, Iwasaki M, Yabe D, Kurose T, Seino Y. Dipeptidyl-peptidase IV inhibitor is effective in patients with type 2 diabetes with high serum eicosapentaenoic acid concentrations. J Diabetes Investig. 2012 Dec 20;3(6):498-502. doi: 10.1111/j.2040-1124.2012.00220.x.

    PMID: 24843614BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphateglimepiride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Results Point of Contact

Title
Dr. Daisuke Yabe
Organization
Kansai Electric Power Medical Research Institute
ydaisuke-kyoto@umin.ac.jp
+81-6-6458-5821

Study Officials

  • Yutaka Seino, MD, PhD

    Kansai Electric Power Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 9, 2014

Study Start

February 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

July 1, 2019

Results First Posted

July 1, 2019

Record last verified: 2019-04

Locations

JP(2)