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

This study has been completed.
Information provided by (Responsible Party):
Eli Lilly and Company Identifier:
First received: July 21, 2011
Last updated: October 26, 2015
Last verified: October 2015
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.

Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Risk factors associated with progression from initial insulin therapy [ Time Frame: Baseline through 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 4530
Study Start Date: July 2011
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Insulin Progressors
Insulin non- progressors


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Eli Lilly and Company Identifier: NCT01400971     History of Changes
Other Study ID Numbers: 14056  F3Z-MC-B010 
Study First Received: July 21, 2011
Last Updated: October 26, 2015
Health Authority: Argentina: Human Research Bioethics Committee
Brazil: National Committee of Ethics in Research
Canada: Ethics Review Committee
China: Ethics Committee
Germany: Ethics Commission
India: Institutional Review Board
Israel: Ethics Commission
Italy: Ethics Committee
Japan: Institutional Review Board
Mexico: Ethics Committee
Russia: Ethics Committee
Russia: Pharmacological Committee, Ministry of Health
Saudi Arabia: Ethics Committee
South Korea: Institutional Review Board
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Ethics Committee
Turkey: Ministry of Health
United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health
United Kingdom: Research Ethics Committee
United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Patient Reported Measures

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 26, 2016