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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01400971
First received: July 21, 2011
Last updated: January 20, 2014
Last verified: January 2014

July 21, 2011
January 20, 2014
July 2011
October 2015   (final data collection date for primary outcome measure)
Risk factors associated with progression from initial insulin therapy [ Time Frame: Baseline through 24 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Number of hypoglycemic episodes [ Time Frame: Baseline through 24 months ] [ Designated as safety issue: No ]
  • Number of participants adhering to prescribed insulin therapy [ Time Frame: Baseline through 24 months ] [ Designated as safety issue: No ]
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
4500
October 2015
October 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:

  • None
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of,   United States,   Argentina,   Brazil,   Canada,   China,   Germany,   India,   Israel,   Italy,   Japan,   United Kingdom,   Mexico,   Puerto Rico,   Russian Federation,   Saudi Arabia,   Spain,   Turkey,   United Arab Emirates
 
NCT01400971
14056, F3Z-MC-B010
No
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
January 2014

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