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
  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:


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: October 2015
Estimated Primary Completion Date: October 2015 (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
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 ClinicalTrials.gov identifier: 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

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: January 20, 2014
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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014