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

This study is currently recruiting participants.
Verified April 2013 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01400971
First received: July 21, 2011
Last updated: April 19, 2013
Last verified: April 2013
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 4500
Study Start Date: July 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Insulin Progressors
Insulin non- progressors

  Eligibility

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.

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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400971

Contacts
Contact: There may be multiple sites in this observational study. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 140 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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01400971     History of Changes
Other Study ID Numbers: 14056, F3Z-MC-B010
Study First Received: July 21, 2011
Last Updated: April 19, 2013
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:
Diabetes
Insulin
Progression
Patient Reported Measures
 Adherence
Heterogeneity
Hypoglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013