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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

January 23, 2010
December 9, 2010
January 2010
November 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01055808 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Observational Study in Japanese Type 2 Diabetes Patients
A Prospective, Non-safety Observational Study in Japanese Type 2 Diabetes Patients(INSIGHTS)

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.

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).

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Diabetes Mellitus, Type 2
Drug: Insulins
Individual dose and frequency and duration as determined by the treating physician
Type 2 diabetes treated with insulin
Intervention: Drug: Insulins
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
677
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01055808
13614, F3Z-JE-PV06
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP