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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.
ClinicalTrials.gov Identifier: NCT01400971
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : October 27, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

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
Primary Completion Date : September 2015
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Insulin Progressors
Insulin non- progressors


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Criteria

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:

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01400971


  Show 153 Study Locations
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov 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:
Diabetes
Insulin
Progression
Patient Reported Measures
Adherence
Heterogeneity
Hypoglycemia

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
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs