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An Observational Study to Understand Challenges Associated With Progression of Insulin Therapy in Type 2 Diabetes (MOSAIc)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01400971
First Posted: July 25, 2011
Last Update Posted: October 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
July 21, 2011
July 25, 2011
October 27, 2015
July 2011
September 2015   (Final data collection date for primary outcome measure)
Risk factors associated with progression from initial insulin therapy [ Time Frame: Baseline through 24 months ]
Same as current
Complete list of historical versions of study NCT01400971 on ClinicalTrials.gov Archive Site
  • Number of participants with failure to achieve Glycosylated Hemoglobin (HbA1c) less than 1.2 times upper limit of normal [ Time Frame: Baseline through 24 months ]
  • Number of hypoglycemic episodes [ Time Frame: Baseline through 24 months ]
  • Number of participants adhering to prescribed insulin therapy [ Time Frame: Baseline through 24 months ]
Same as current
Not Provided
Not Provided
 
An Observational Study to Understand Challenges Associated With Progression of Insulin Therapy in Type 2 Diabetes
A Multinational Observational Study Assessing Insulin Use: Understanding the Challenges Associated With Progression of Therapy - The MOSAIc Type 2 Diabetes Study
The purpose of this study is to identify specific patient, physician, and health system related factors associated with the progression to a more intensive regimen from initial insulin therapy for patients with type 2 diabetes.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with Type 2 diabetes attending primary care and diabetes specialty clinics.
Diabetes Mellitus, Type 2
Not Provided
  • Insulin Progressors
  • Insulin non- progressors

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4530
September 2015
September 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have been diagnosed with type 2 diabetes
  • Have presented within the normal course of care
  • Have been on their initial insulin therapy for ≥3 months (with or without any combination of approved non-insulin anti-diabetic medications)
  • Are not simultaneously participating in a study that includes an investigational drug or procedure at entry into the study
  • Have been fully informed and have given written consent for the use of their data
  • Have a sufficient understanding of the primary language of the country such that they will be able to complete the questionnaires
  • Have not initiated basal bolus therapy (three mealtime insulin injections)

Exclusion Criteria:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Canada,   China,   Germany,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Puerto Rico,   Russian Federation,   Saudi Arabia,   Spain,   Turkey,   United Arab Emirates,   United Kingdom,   United States
 
 
NCT01400971
14056
F3Z-MC-B010 ( Other Identifier: Eli Lilly and Company )
No
Not Provided
Not Provided
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
October 2015