NCT01400971

Brief 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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
4,299

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
19 countries

153 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

March 9, 2020

Completed
Last Updated

March 9, 2020

Status Verified

February 1, 2020

Enrollment Period

4.2 years

First QC Date

July 21, 2011

Results QC Date

February 25, 2020

Last Update Submit

February 25, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

DiabetesInsulinProgressionPatient Reported MeasuresAdherenceHeterogeneityHypoglycemia

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline through 24 months

Secondary Outcomes (3)

  • Number of Hypoglycemic and Severe Hypoglycemic Episodes

    Baseline through 24 months

  • Number of Participants Adherent to Prescribed Insulin Therapy During the Study (Study Adherent)

    Baseline through 24 months

  • Number of Participants Who Achieved Their Personalized HbA1c Target by the End of the Study

    Baseline through 24 months

Study Arms (1)

MOSAIc Participants

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (153)

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Little Rock, Arkansas, 72204, United States

Location

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Orlando, Florida, 32806, United States

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Wellington, Florida, 33414, United States

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Canton, Georgia, 30114, United States

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Crystal Lake, Illinois, 60012, United States

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North Platte, Nebraska, 69101, United States

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Reno, Nevada, 89511, United States

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Burlington, North Carolina, 27215, United States

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Greensboro, North Carolina, 27408, United States

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Morganton, North Carolina, 28655, United States

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Tabor City, North Carolina, 28463, United States

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Johnstown, Pennsylvania, 15905, United States

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Levittown, Pennsylvania, 19056, United States

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Charleston, South Carolina, 29412, United States

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Kingsport, Tennessee, 37660, United States

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Dallas, Texas, 75235, United States

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Fort Worth, Texas, 76104, United States

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Georgetown, Texas, 78626, United States

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Houston, Texas, 77074, United States

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Plano, Texas, 75023, United States

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Alexandria, Virginia, 22304, United States

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Richmond, Virginia, 23219, United States

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Buenos Aires, CBA 1419, Argentina

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Corrientes, 3400, Argentina

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Mendoza, 5500, Argentina

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Paraná, 3100, Argentina

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Rosario, S2000DSZ, Argentina

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San Juan, 5400, Argentina

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Campina Grande do Sul, 83430-000, Brazil

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Caxias do Sul, 95070560, Brazil

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Fortaleza, 60430-370, Brazil

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Santa Maria, 97015-530, Brazil

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São Paulo, 04020-041, Brazil

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Setor Oeste/Goiania, 74100-120, Brazil

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Tatuí, 18270-170, Brazil

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Edmonton, Alberta, T5A 4L8, Canada

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Spruce Grove, Alberta, T7X 2V2, Canada

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Winnipeg, Manitoba, R3C 0N2, Canada

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St. John's, Newfoundland and Labrador, A1A3R5, Canada

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Burlington, Ontario, L7M 4Y1, Canada

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London, Ontario, N6A 5G6, Canada

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Smiths Falls, Ontario, K7A 4W8, Canada

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Gatineau, Quebec, J8V 2P5, Canada

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Montreal, Quebec, H3N 1S4, Canada

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Sherbrooke, Quebec, J1G 1B8, Canada

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Beijing, 100101, China

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Changchun, 130041, China

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Chongqing, China

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Guangzhou, 510080, China

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Shijiazhuang, 50000, China

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Xi'an, 710061, China

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Bosenheim, 55545, Germany

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Cologne, 51069, Germany

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Dresden, 01307, Germany

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Essen, 45359, Germany

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Hamburg, 22415, Germany

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Hohenmölsen, 06679, Germany

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Kamp-Lintfort, 47475, Germany

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Lambrecht, 67466, Germany

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Schramberg, 78713, Germany

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Speyer, 67346, Germany

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Ahmedabad, 380007, India

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Ahmedabad, Gujarat, 380009, India

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Bangalore, 560054, India

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Belagavi, 590001, India

Location

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Hyderabaad, 500033, India

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Jaipur, 302020, India

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Kormangala, 560034, India

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Mangalore, 575001, India

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Mumbai, 400053, India

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Mysore, 570023, India

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Nagpur, 440025, India

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New Delhi, 110070, India

Location

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Pune, 411035, India

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Beer Yaakov, 70300, Israel

Location

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Beersheba, 84350, Israel

Location

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Dimona, 68000, Israel

Location

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Giv‘atayim, 53488, Israel

Location

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Netanya, 42470, Israel

Location

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Petah Tikva, 49582, Israel

Location

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Rishon LeZiyyon, 75650, Israel

Location

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Safed, 13110, Israel

Location

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Acquaviva delle Fonti, 70021, Italy

Location

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Ancona, 60110, Italy

Location

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Foggia, 71100, Italy

Location

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Lucca, 55100, Italy

Location

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Napoli, 80131, Italy

Location

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Parma, 43100, Italy

Location

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Pavia, 27100, Italy

Location

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Rome, 00168, Italy

Location

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San Giovanni Rotondo, 71013, Italy

Location

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Siena, 53100, Italy

Location

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Kanagawa, 242-0004, Japan

Location

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Kanagawa-Ken, 232-0071, Japan

Location

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Aguascalientes, 20217, Mexico

Location

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Durango, 34080, Mexico

Location

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Guadalajara, 44680, Mexico

Location

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Huixquilucan, 52763, Mexico

Location

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Mexico City, 11850, Mexico

Location

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Zapopan, 45200, Mexico

Location

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Bayamón, 00956, Puerto Rico

Location

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Carolina, 00983, Puerto Rico

Location

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Loíza, 772, Puerto Rico

Location

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Rio Piedras, 00921, Puerto Rico

Location

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Río Grande, 00745, Puerto Rico

Location

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San Juan, 00920, Puerto Rico

Location

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Toa Baja, 00949, Puerto Rico

Location

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Villa Fontana, 00983, Puerto Rico

Location

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Moscow, 117997, Russia

Location

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Nizhny Novgorod, 603126, Russia

Location

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Rostov-on-Don, 344022, Russia

Location

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Saint Petersburg, 194358, Russia

Location

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Tomsk, 634050, Russia

Location

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Vsevolozhsk, 188640, Russia

Location

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Yaroslavl, 150010, Russia

Location

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Dammam, 31412, Saudi Arabia

Location

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Mecca, 21955, Saudi Arabia

Location

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Riyadh, 245, Saudi Arabia

Location

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Ta'if, 21944, Saudi Arabia

Location

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Daegu, 705-717, South Korea

Location

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Daejeon, 301-721, South Korea

Location

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Gangwon-Do, 200-722, South Korea

Location

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Goyang-si, 412-270, South Korea

Location

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Jeju Special Self-Governing Pr, 690-767, South Korea

Location

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Sungnam-Si, 463-712, South Korea

Location

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Barcelona, 8025, Spain

Location

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Gerena, Spain

Location

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La Roca del Vallès, 8430, Spain

Location

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Madrid, 28034, Spain

Location

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Seville, 41009, Spain

Location

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Vic, 08500, Spain

Location

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Ankara, 6560, Turkey (Türkiye)

Location

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Çanakkale, 06310, Turkey (Türkiye)

Location

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Diyarbakır, 21280, Turkey (Türkiye)

Location

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Gaziantep, 27310, Turkey (Türkiye)

Location

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Istanbul, 34865, Turkey (Türkiye)

Location

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Izmir, Turkey (Türkiye)

Location

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Kahramanmaraş, 46050, Turkey (Türkiye)

Location

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Kırıkkale, 71450, Turkey (Türkiye)

Location

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Abu Dhabi, United Arab Emirates

Location

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Al Ain City, United Arab Emirates

Location

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Dubai, 9115, United Arab Emirates

Location

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Sharjah city, United Arab Emirates

Location

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Bath, Avon, BA2 3HT, United Kingdom

Location

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Torpoint, Cornwall, PL11 2JW, United Kingdom

Location

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Manchester, Greater Manchester, M20 2RN, United Kingdom

Location

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Bolton, Lancashire, BL3 6TL, United Kingdom

Location

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Doncaster, South Yorkshire, DN9 1EP, United Kingdom

Location

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Atherstone, Warwickshire, CV9 1EU, United Kingdom

Location

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Swansea, West Glamorgan, SA2 8QA, United Kingdom

Location

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Bradford-on-Avon, Wiltshire, BA15 1DQ, United Kingdom

Location

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Cardiff, CF5 4AD, United Kingdom

Location

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Chesterfield, S40 4TF, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 34988917DERIVED

  • 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.

    PMID: 34535360DERIVED

  • 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.

    PMID: 27453733DERIVED

  • 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.

    PMID: 27255328DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInsulin ResistanceDisease ProgressionHypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2011

First Posted

July 25, 2011

Study Start

July 1, 2011

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 9, 2020

Results First Posted

March 9, 2020

Record last verified: 2020-02

Locations

SA(4)TU(8)GB(10)KR(6)AE(4)ES(6)BR(7)PR(8)IL(8)IN(13)CN(6)US(22)JP(2)AR(6)CA(10)DE(10)ME(6)IT(10)RU(7)