Diabetes Mellitus, Type 2MOSAIcNCT01400971

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

An observational study of Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 153 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
How many people: 4,299 participants
Where: 153 sitesin 19 countries
Study dates: Jul 2011to Sep 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with Type 2 diabetes attending primary care and diabetes specialty clinics.

Who may be able to join

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)

Who cannot join

None

Trial locations and contacts

153 sites in 19 countries.

Country

City, postcode or hospital

153 sites in 19 countries

United States22 sites

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Alexandria, Virginia, 22304
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Burlington, North Carolina, 27215
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Canton, Georgia, 30114
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Charleston, South Carolina, 29412
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Crystal Lake, Illinois, 60012
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Dallas, Texas, 75235
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Fort Worth, Texas, 76104
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Georgetown, Texas, 78626
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Greensboro, North Carolina, 27408
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Houston, Texas, 77074
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Johnstown, Pennsylvania, 15905
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Kingsport, Tennessee, 37660
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Levittown, Pennsylvania, 19056
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Little Rock, Arkansas, 72204
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Morganton, North Carolina, 28655
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North Platte, Nebraska, 69101
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Orlando, Florida, 32806
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Plano, Texas, 75023
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Reno, Nevada, 89511
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Richmond, Virginia, 23219
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Tabor City, North Carolina, 28463
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Wellington, Florida, 33414

Other trials in United States

India13 sites

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Ahmedabad, 380007
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Ahmedabad, Gujarat, 380009
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Bangalore, 560054
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Belagavi, 590001
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Hyderabaad, 500033
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Jaipur, 302020
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Kormangala, 560034
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Mangalore, 575001
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Mumbai, 400053
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Mysore, 570023
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Nagpur, 440025
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New Delhi, 110070
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Pune, 411035

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Canada10 sites

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Burlington, Ontario, L7M 4Y1
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Edmonton, Alberta, T5A 4L8
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Gatineau, Quebec, J8V 2P5
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London, Ontario, N6A 5G6
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Montreal, Quebec, H3N 1S4
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Sherbrooke, Quebec, J1G 1B8
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Smiths Falls, Ontario, K7A 4W8
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Spruce Grove, Alberta, T7X 2V2
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St. John's, Newfoundland and Labrador, A1A3R5
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Winnipeg, Manitoba, R3C 0N2

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Germany10 sites

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Bosenheim, 55545
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Cologne, 51069
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Dresden, 01307
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Essen, 45359
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Hamburg, 22415
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Hohenmölsen, 06679
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Kamp-Lintfort, 47475
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Lambrecht, 67466
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Schramberg, 78713
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Speyer, 67346

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Italy10 sites

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Acquaviva delle Fonti, 70021
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Ancona, 60110
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Foggia, 71100
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Lucca, 55100
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Naples, 80131
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Parma, 43100
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Pavia, 27100
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Rome, 00168
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San Giovanni Rotondo, 71013
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Siena, 53100

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United Kingdom10 sites

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Atherstone, Warwickshire, CV9 1EU
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Bath, Avon, BA2 3HT
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Bolton, Lancashire, BL3 6TL
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Bradford on Avon, Wiltshire, BA15 1DQ
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Cardiff, CF5 4AD
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Chesterfield, S40 4TF
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Doncaster, South Yorkshire, DN9 1EP
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Manchester, Greater Manchester, M20 2RN
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Swansea, West Glamorgan, SA2 8QA
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Torpoint, Cornwall, PL11 2JW

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Israel8 sites

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Beer Yaakov, 70300
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Beersheba, 84350
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Dimona, 68000
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Giv‘atayim, 53488
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Netanya, 42470
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Petah Tikva, 49582
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Rishon LeZiyyon, 75650
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Safed, 13110

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Puerto Rico8 sites

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Bayamón, 00956
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Carolina, 00983
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Loiza, 772
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Rio Grande, 00745
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Rio Piedras, 00921
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San Juan, 00920
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Toa Baja, 00949
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Villa Fontana, 00983

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Turkey (Türkiye)8 sites

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Ankara, 6560
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Çanakkale, 06310
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Diyarbakır, 21280
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Gaziantep, 27310
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Istanbul, 34865
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Izmir
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Kahramanmaraş, 46050
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Kirikkale, 71450

Other trials in Turkey (Türkiye)

Brazil7 sites

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Campina Grande do Sul, 83430-000
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Caxias do Sul, 95070560
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Fortaleza, 60430-370
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Santa Maria, 97015-530
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São Paulo, 04020-041
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Setor Oeste/Goiania, 74100-120
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Tatuí, 18270-170

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Russia7 sites

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Moscow, 117997
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Nizhny Novgorod, 603126
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Rostov-on-Don, 344022
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Saint Petersburg, 194358
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Tomsk, 634050
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Vsevolozhsk, 188640
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Yaroslavl, 150010

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Argentina6 sites

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Buenos Aires, CBA 1419
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Corrientes, 3400
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Mendoza, 5500
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Paraná, 3100
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Rosario, S2000DSZ
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San Juan, 5400

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China6 sites

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Beijing, 100101
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Changchun, 130041
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Chongqing
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Guangzhou, 510080
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Shijiazhuang, 50000
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Xi'an, 710061

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Mexico6 sites

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Aguascalientes, 20217
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Durango, 34080
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Guadalajara, 44680
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Huixquilucan, 52763
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Mexico City, 11850
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Zapopan, 45200

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South Korea6 sites

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Daegu, 705-717
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Daejeon, 301-721
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Gangwon-Do, 200-722
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Goyang-si, 412-270
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Jeju Special Self-Governing Pr, 690-767
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Sungnam-Si, 463-712

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Spain6 sites

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Barcelona, 8025
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Gerena
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La Roca del Vallès, 8430
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Madrid, 28034
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Seville, 41009
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Vic, 08500

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Saudi Arabia4 sites

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Dammam, 31412
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Mecca, 21955
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Riyadh, 245
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Ta'if, 21944

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United Arab Emirates4 sites

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Abu Dhabi
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Al Ain City
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Dubai, 9115
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Sharjah city

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Japan2 sites

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Kanagawa, 242-0004
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Kanagawa-Ken, 232-0071

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About this study

Official title: A Multinational Observational Study Assessing Insulin Use: Understanding the Challenges Associated With Progression of Therapy - The MOSAIc Type 2 Diabetes Study

Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes, Insulin, Progression, Patient Reported Measures, Adherence, Heterogeneity, Hypoglycemia
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance, Disease Progression, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01400971
Study group	Role	What they receive
MOSAIc Participants		Participants enrolled in Multinational Observational Study Assessing Insulin use (MOSAIc) who had complete treatment data during the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Insulin-Related Treatment Change From Initial Insulin Therapy
Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. Discrimination domain of the Interpersonal Processes of Care Survey [IPC] ranges from 1-5 with higher scores indicating more discrimination and Diabetes Distress Scale ranges from 1-6 with higher scores indicating more distress.
Measured: Baseline through 24 months

Secondary outcomes (3)

Number of Hypoglycemic and Severe Hypoglycemic Episodes
Hypoglycemia and severe hypoglycemia episodes are self-reported by all participants with complete treatment data from one month prior to the baseline visit until the last visit (24 months). Patients were asked at each visit to self-report any hypoglycemia since their last visit. At the baseline visit participants were asked their hypoglycemia information for the month prior to the baseline visit.
Measured: Baseline through 24 months
Number of Participants Adherent to Prescribed Insulin Therapy During the Study (Study Adherent)
MOSAIC participants answered the question: "How often did you miss your insulin shots during the last 7 days?". At each visit, participants were defined as visit adherent if the participant answered "I did not miss any shots" or "I missed some of my shots". They were defined as not visit adherent if he/she answered any of the following: "I missed about half of my shots", "I missed most of my shots", or "I missed all of my shots". A participant is defined to be study adherent if at least: 4 out of 5 visit adherent.
Measured: Baseline through 24 months
Number of Participants Who Achieved Their Personalized HbA1c Target by the End of the Study
As diabetes management practices vary across the countries represented in MOSAIC, a more apt measure of reaching goal is the personalized target that was set for each patient at the beginning of the study.
Measured: Baseline through 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Sep 2015

First posted25 Jul 2011 (estimated)
Study startJul 2011
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 4,299 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01400971
Sponsor's protocol ID: 14056
Other IDs: F3Z-MC-B010
Acronym: MOSAIc
Status last verified: Feb 2020
First submitted: 21 Jul 2011
Last updated: 9 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Matsuba I, Kawata T, Ajima M, Umezawa S, Kaneshiro M, Asakura T, Machimura H, Sawa T, Tanaka K, Takeda H, Imaoka T, Kanamori A. Multinational Observational Study to Understand Insulin Treatment Intensification: Japanese Subgroup Analysis of the MOSAIc Study. Diabetes Ther. 2022 Feb;13(2):265-274. doi: 10.1007/s13300-021-01195-8. Epub 2022 Jan 6.
PubMed 34988917
Caballero AE, Nordstrom BL, Liao B, Fan L, Zhang N, Fraeman KH, Perez-Nieves M. Individualized HbA1c target selection and achievement in the Multinational Observational Study Assessing Insulin Use (MOSA1c) type 2 diabetes study. J Diabetes Complications. 2021 Nov;35(11):108011. doi: 10.1016/j.jdiacomp.2021.108011. Epub 2021 Jul 30.
PubMed 34535360
Linetzky B, Curtis B, Frechtel G, Montenegro R Jr, Escalante Pulido M, Stempa O, de Lana JM, Gagliardino JJ. Challenges associated with insulin therapy progression among patients with type 2 diabetes: Latin American MOSAIc study baseline data. Diabetol Metab Syndr. 2016 Jul 22;8:41. doi: 10.1186/s13098-016-0157-1. eCollection 2016.
PubMed 27453733
Matsuba I, Sawa T, Kawata T, Kanamori A, Jiang D, Machimura H, Takeda H, Han JH, Wang K, Tanaka K, Shen L, Ajima M, Kaneshiro M, Kim SW, Umezawa S, Asakura T, Suzuki S, Kim SC. Cross-National Variation in Glycemic Control and Diabetes-Related Distress Among East Asian Patients Using Insulin: Results from the MOSAIc Study. Diabetes Ther. 2016 Jun;7(2):349-60. doi: 10.1007/s13300-016-0178-7. Epub 2016 Jun 2.
PubMed 27255328

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multinational Observational Study Assessing Insulin Use: Understanding the Challenges Associated With Progression of Therapy - The MOSAIc Type 2 Diabetes Study
ClinicalTrials.gov ID: NCT01400971
Acronym / sponsor ID: MOSAIc / 14056
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes, Insulin, Progression, Patient Reported Measures, Adherence, Heterogeneity, Hypoglycemia
Study type: Observational
Recruitment status: Completed
Enrolment: 4,299 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 25 Jul 2011 (estimated)
Results: Posted 9 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
MOSAIc Participants	–	–Participants enrolled in Multinational Observational Study Assessing Insulin use (MOSAIc) who had complete treatment data during the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with Type 2 diabetes attending primary care and diabetes specialty clinics.

Key inclusion criteria (7 listed)

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

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number of Participants With Insulin-Related Treatment Change From Initial Insulin Therapy
Time frame: Baseline through 24 months
Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. Discrimination domain of the Interpersonal Processes of Care Survey [IPC] ranges from 1-5 with higher scores indicating more discrimination and Diabetes Distress Scale ranges from 1-6 with higher scores indicating more distress.

3 secondary outcomes

Number of Hypoglycemic and Severe Hypoglycemic Episodes
Time frame: Baseline through 24 months
Number of Participants Adherent to Prescribed Insulin Therapy During the Study (Study Adherent)
Time frame: Baseline through 24 months
Number of Participants Who Achieved Their Personalized HbA1c Target by the End of the Study
Time frame: Baseline through 24 months

Results and safety

Results posted to the registry on 9 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MOSAIc Participants	4,299	3,382

Primary outcome: Number of Participants With Insulin-Related Treatment Change From Initial Insulin Therapy

Time frame: Baseline through 24 months. Count of participants. Unit: Participants

Measure	MOSAIc Participants n = 2528
Value	2171

MOSAIc Participants: Odds Ratio (OR): 0.70 (95% CI 0.54 to 0.92)
MOSAIc Participants: Odds Ratio (OR): 1.92 (95% CI 1.50 to 2.46)
MOSAIc Participants: Odds Ratio (OR): 1.85 (95% CI 1.38 to 2.49)

Population analysed: All participants enrolled in MOSAIc who had complete treatment data during the study.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline Through Up To 24 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MOSAIc Participants	130 of 2,528 (5.1%)	1,199 of 2,528 (47.4%)	82 of 4,299

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34988917Matsuba I, Kawata T, Ajima M, Umezawa S, Kaneshiro M, Asakura T, Machimura H, Sawa T, Tanaka K, Takeda H, Imaoka T, Kanamori A. Multinational Observational Study to Understand Insulin Treatment Intensification: Japanese Subgroup Analysis of the MOSAIc Study. Diabetes Ther. 2022 Feb;13(2):265-274. doi: 10.1007/s13300-021-01195-8. Epub 2022 Jan 6.
Derived from this study: PubMed 34535360Caballero AE, Nordstrom BL, Liao B, Fan L, Zhang N, Fraeman KH, Perez-Nieves M. Individualized HbA1c target selection and achievement in the Multinational Observational Study Assessing Insulin Use (MOSA1c) type 2 diabetes study. J Diabetes Complications. 2021 Nov;35(11):108011. doi: 10.1016/j.jdiacomp.2021.108011. Epub 2021 Jul 30.
Derived from this study: PubMed 27453733Linetzky B, Curtis B, Frechtel G, Montenegro R Jr, Escalante Pulido M, Stempa O, de Lana JM, Gagliardino JJ. Challenges associated with insulin therapy progression among patients with type 2 diabetes: Latin American MOSAIc study baseline data. Diabetol Metab Syndr. 2016 Jul 22;8:41. doi: 10.1186/s13098-016-0157-1. eCollection 2016.
Derived from this study: PubMed 27255328Matsuba I, Sawa T, Kawata T, Kanamori A, Jiang D, Machimura H, Takeda H, Han JH, Wang K, Tanaka K, Shen L, Ajima M, Kaneshiro M, Kim SW, Umezawa S, Asakura T, Suzuki S, Kim SC. Cross-National Variation in Glycemic Control and Diabetes-Related Distress Among East Asian Patients Using Insulin: Results from the MOSAIc Study. Diabetes Ther. 2016 Jun;7(2):349-60. doi: 10.1007/s13300-016-0178-7. Epub 2016 Jun 2.

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Type 2 Diabetes Mellitus (T2DM)
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

153 sites in 19 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 153 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in United States, India, Canada, Germany, Italy and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Insulin-Related Treatment Change From Initial Insulin Therapy (time frame: Baseline through 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01400971, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020; AzTrials last refreshed its copy on 30 Oct 2026.