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

  Hide Study Locations
Locations
United States, Arkansas
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Little Rock, Arkansas, United States, 72204
United States, Florida
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Orlando, Florida, United States, 32806
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Wellington, Florida, United States, 33414
United States, Georgia
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Canton, Georgia, United States, 30114
United States, Illinois
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Crystal Lake, Illinois, United States, 60012
United States, Nebraska
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North Platte, Nebraska, United States, 69101
United States, Nevada
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Reno, Nevada, United States, 89511
United States, North Carolina
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Burlington, North Carolina, United States, 27215
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Greensboro, North Carolina, United States, 27408
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Morganton, North Carolina, United States, 28655
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Tabor City, North Carolina, United States, 28463
United States, Pennsylvania
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Johnstown, Pennsylvania, United States, 15905
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Levittown, Pennsylvania, United States, 19056
United States, South Carolina
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Charleston, South Carolina, United States, 29412
United States, Tennessee
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Kingsport, Tennessee, United States, 37660
United States, Texas
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Dallas, Texas, United States, 75235
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Ft.Worth, Texas, United States, 76104
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Georgetown, Texas, United States, 78626
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Houston, Texas, United States, 77074
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Plano, Texas, United States, 75023
United States, Virginia
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Alexandria, Virginia, United States, 22304
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Richmond, Virginia, United States, 23219
Argentina
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Buenos Aires, Argentina, CBA 1419
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Corrientes, Argentina, 3400
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Mendoza, Argentina, 5500
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Parana, Argentina, 3100
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Rosario, Argentina, S2000DSZ
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San Juan, Argentina, 5400
Brazil
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Campina Grande Do Sul, Brazil, 83430-000
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Caxias Do Sul, Brazil, 95070560
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Fortaleza, Brazil, 60430-370
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Santa Maria, Brazil, 97015-530
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Setor Oeste/Goiania, Brazil, 74100-120
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São Paulo, Brazil, 04020-041
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Tatui, Brazil, 18270-170
Canada, Alberta
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Edmonton, Alberta, Canada, T5A 4L8
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Spruce Grove, Alberta, Canada, T7X 2V2
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3C 0N2
Canada, Newfoundland and Labrador
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St. John'S, Newfoundland and Labrador, Canada, A1A3R5
Canada, Ontario
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Burlington, Ontario, Canada, L7M 4Y1
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London, Ontario, Canada, N6A 5G6
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Smiths Falls, Ontario, Canada, K7A 4W8
Canada, Quebec
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Gatineau, Quebec, Canada, J8V 2P5
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Montreal, Quebec, Canada, H3N 1S4
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Sherbrooke, Quebec, Canada, J1G 1B8
China
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Beijing, China, 100101
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Changchun City, China, 130041
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Chongqing, China
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Guang Zhou, China, 510080
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Shijiazhuang, China, 50000
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Xi'An, China, 710061
Germany
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Bosenheim, Germany, 55545
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Dresden, Germany, 01307
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Essen, Germany, 45359
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Hamburg, Germany, 22415
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Hohenmölsen, Germany, 06679
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Kamp-Lintfort, Germany, 47475
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Köln, Germany, 51069
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Lambrecht, Germany, 67466
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Schramberg, Germany, 78713
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Speyer, Germany, 67346
India
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Ahmedabad, India, 380007
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Ahmedabad, Gujarat, India, 380009
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Bangalore, India, 560054
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Belgaum, India, 590001
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Hyderabaad, India, 500033
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Jaipur, India, 302020
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Kormangala, India, 560034
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Mangalore, India, 575001
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Mumbai, India, 400053
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Mysore, India, 570023
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Nagpur, India, 440025
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New Delhi, India, 110070
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Pune, India, 411035
Israel
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Beer Sheva, Israel, 84350
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Beer Yaakov, Israel, 70300
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Dimona, Israel, 68000
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Givataim, Israel, 53488
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Netanya, Israel, 42470
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Petach Tikwa, Israel, 49582
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Rishon Le Zion, Israel, 75650
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Safed, Israel, 13110
Italy
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Acquaviva Delle Fonti, Italy, 70021
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Ancona, Italy, 60110
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Foggia, Italy, 71100
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Lucca, Italy, 55100
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Napoli, Italy, 80131
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Parma, Italy, 43100
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Pavia, Italy, 27100
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Rome, Italy, 00168
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San Giovanni Rotondo, Italy, 71013
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Siena, Italy, 53100
Japan
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Kanagawa, Japan, 242-0004
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Kanagawa-Ken, Japan, 232-0071
Korea, Republic of
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Daegu, Korea, Republic of, 705-717
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Daejeon, Korea, Republic of, 301-721
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Gangwon-Do, Korea, Republic of, 200-722
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Goyang-Si, Korea, Republic of, 412-270
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Jeju Special Self-Governing Pr, Korea, Republic of, 690-767
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Sungnam-Si, Korea, Republic of, 463-712
Mexico
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Aguascalientes, Mexico, 20217
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Durango, Mexico, 34080
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Guadalajara, Mexico, 44680
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Huixquilucan, Mexico, 52763
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Mexico City, Mexico, 11850
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Zapopan, Mexico, 45200
Puerto Rico
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Bayamon, Puerto Rico, 00956
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Carolina, Puerto Rico, 00983
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Loiza, Puerto Rico, 772
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Rio Grande, Puerto Rico, 00745
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Rio Piedras, Puerto Rico, 00921
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San Juan, Puerto Rico, 00920
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Toa Baja, Puerto Rico, 00949
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Villa Fontana, Puerto Rico, 00983
Russian Federation
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Moscow, Russian Federation, 117997
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Nizhniy Novgorod, Russian Federation, 603126
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Rostov-On-Don, Russian Federation, 344022
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Saint Petersburg, Russian Federation, 194358
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Tomsk, Russian Federation, 634050
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Vsevolozhsk, Russian Federation, 188640
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Yaroslavl, Russian Federation, 150010
Saudi Arabia
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Dammam, Saudi Arabia, 31412
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Makkah, Saudi Arabia, 21955
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Riyadh, Saudi Arabia, 245
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Taif, Saudi Arabia, 21944
Spain
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Barcelona, Spain, 8025
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Gerena, Spain
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La Roca Del Valles, Spain, 8430
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Madrid, Spain, 28034
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Sevilla, Spain, 41009
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Vic, Spain, 08500
Turkey
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Ankara, Turkey, 6560
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Canakkale, Turkey, 06310
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Diyarbakir, Turkey, 21280
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Gaziantep, Turkey, 27310
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Istanbul, Turkey, 34865
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Izmir, Turkey
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Kahramanmaras, Turkey, 46050
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Kirikkale, Turkey, 71450
United Arab Emirates
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Abu Dhabi, United Arab Emirates
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Al Ain, United Arab Emirates
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Dubai, United Arab Emirates, 9115
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Sharjah, United Arab Emirates
United Kingdom
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Bath, Avon, United Kingdom, BA2 3HT
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Torpoint, Cornwall, United Kingdom, PL11 2JW
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Manchester, Greater Manchester, United Kingdom, M20 2RN
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Bolton, Lancashire, United Kingdom, BL3 6TL
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Doncaster, South Yorkshire, United Kingdom, DN9 1EP
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Atherstone, Warwickshire, United Kingdom, CV9 1EU
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Swansea, West Glamorgan, United Kingdom, SA2 8QA
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Bradford On Avon, Wiltshire, United Kingdom, BA15 1DQ
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Cardiff, United Kingdom, CF5 4AD
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Chesterfield, United Kingdom, S40 4TF
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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014