NCT01855087

Brief Summary

There is paucity of information about the combination therapy with dipeptidyl peptidase-4 inhibitor sitagliptin and insulin. This study aimed to retrospectively investigate the safety and efficacy of this therapeutic modality in Japanese patients with type 2 diabetes.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
Last Updated

May 16, 2013

Status Verified

May 1, 2013

First QC Date

May 10, 2013

Last Update Submit

May 13, 2013

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Blood glucose level

    Six months after starting sitagliptin-insulin combination therapy

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

One-thousand Japanese patients with type 2 diabetes

You may qualify if:

  • outpatients with type 2 diabetes
  • addition of sitagliptin to insulin therapy
  • aged 20 years or older
  • HbA1c of 6.9% or higher (NGSP) at the time of adding sitagliptin

You may not qualify if:

  • history of hypersensitivity to sitagliptin
  • severe ketosis, diabetic coma, and/or precoma within 6 months before sitagliptin administration
  • sever infection and/or severe trauma, and/or patients who are scheduled to undergo / have recently underwent surgery
  • severe renal dysfunction (serum creatinine \[mg/dL\]: 2.5 or higher for men; 2.0 or higher for women)
  • ongoing treatment with glinide(s)
  • judgment as ineligible for the study by the attending physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Takai Naika Clinic

Kamakura, Kanagawa, 247-0056, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairperson

Study Record Dates

First Submitted

May 10, 2013

First Posted

May 16, 2013

Primary Completion

March 1, 2013

Last Updated

May 16, 2013

Record last verified: 2013-05

Locations

JP(1)