Observational Study in Japanese Type 2 Diabetes Patients (INSIGHTS)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01055808
First received: January 23, 2010
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

This study is designed to address the gap in the literature related to changing treatment regimen or formulation between different types of insulin, and how this change impacts quality of life, adherence, individual patient treatment satisfaction and glycemic control.


Condition Intervention
Diabetes Mellitus, Type 2
Drug: Insulins

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective, Non-safety Observational Study in Japanese Type 2 Diabetes Patients(INSIGHTS)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Changes in Health Related Quality of Life (ITR-QOL) in insulin treated type 2 diabetes at baseline and 12 weeks after a significant change in insulin treatment regimen [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Summarize by occurrence the reason for insulin treatment change at study entry [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Change in HbA1c at baseline and 12 weeks after a significant change in insulin treatment regimen [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change in treatment adherence at baseline and 12 weeks after a significant change in insulin treatment regimen [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change in DTSQ (Diabetes treatment satisfaction questionnaire) at baseline and 12 weeks after a significant change in insulin treatment regimen [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Total daily dose of insulin [ Time Frame: Baseline, over 12 weeks ] [ Designated as safety issue: No ]
  • Change in type of insulin product [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in use of concomitant oral hypoglycemic drugs [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 677
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Type 2 diabetes treated with insulin Drug: Insulins
Individual dose and frequency and duration as determined by the treating physician

Detailed Description:

To measure changes in Health Related Quality of Life (as measured by the Insulin Therapy Related-Quality of Life: ITR-QOL) in insulin treated type 2 diabetes over a 12 weeks period following a significant change in insulin treatment regimen. Definition of significant change is a) increase or decrease the in number of injections per day, or/and b) change in formulation of insulin (human or analog insulin, basal or bolus, rapid or mix insulin), and/or c) change in administration method (syringe or pen, disposal or re-usable).

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Japanese patients with type 2 diabetes who are treated with insulin and about to have significant treatment change.

Criteria

Inclusion Criteria:

  • Inpatients or outpatients with type 2 diabetes, aged 20 years or older, on insulin therapy who have planned to change insulin therapy during the registration period of the study
  • Patients who have provided written informed consent to participation in the study after receiving explanations about the objective and other details of the study
  • Patients who have received the same insulin therapy for 3 months or longer before informed consent. (i.e. receiving the same type of insulin preparation at the same dosing frequency regardless of insulin dose)

Exclusion Criteria:

  • Patients who have planned to discontinue insulin therapy
  • Patients incapable of completing the ITR-QOL, DTSQ and patient's questionnaire based on their self-ratings
  • Patients with type 1 diabetes
  • Patients who have used CSII or have planned to switch to CSII(continuous subcutaneous insulin infusion )
  • Patients with poor treatment compliance as determined by their investigators based on the treatment history
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055808

Locations
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hyogo, Japan, 651-0086
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri from 9AM-5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT01055808     History of Changes
Other Study ID Numbers: 13614, F3Z-JE-PV06
Study First Received: January 23, 2010
Last Updated: December 9, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Eli Lilly and Company:
Insulin
ITR-QOL
DTSQ
Diabetes Mellitus, Type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014