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

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. Identifier: NCT01400971
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : October 27, 2015
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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.

Condition or disease
Diabetes Mellitus, Type 2

Study Type : Observational
Actual Enrollment : 4530 participants
Time Perspective: Prospective
Official Title: A Multinational Observational Study Assessing Insulin Use: Understanding the Challenges Associated With Progression of Therapy - The MOSAIc Type 2 Diabetes Study
Study Start Date : July 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Insulin Progressors
Insulin non- progressors

Primary Outcome Measures :
  1. Risk factors associated with progression from initial insulin therapy [ Time Frame: Baseline through 24 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of hypoglycemic episodes [ Time Frame: Baseline through 24 months ]
  3. Number of participants adhering to prescribed insulin therapy [ Time Frame: Baseline through 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Type 2 diabetes attending primary care and diabetes specialty clinics.

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01400971

  Show 153 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eli Lilly and Company Identifier: NCT01400971     History of Changes
Other Study ID Numbers: 14056
F3Z-MC-B010 ( Other Identifier: Eli Lilly and Company )
First Posted: July 25, 2011    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015

Keywords provided by Eli Lilly and Company:
Patient Reported Measures

Additional relevant MeSH terms:
Diabetes Mellitus
Disease Progression
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs