Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01507116
Other study ID # INS-3966
Secondary ID U1111-1123-7509
Status Completed
Phase N/A
First received January 4, 2012
Last updated January 18, 2017
Start date March 2012
Est. completion date September 2012

Study information

Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study is conducted in Africa, Asia, Europe, Japan, North America and South America.

The multinational surveys will explore the experiences and unmet needs of people with diabetes, as well as those of family members of people with diabetes, and of healthcare professionals treating people with diabetes.


Recruitment information / eligibility

Status Completed
Enrollment 8985
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults aged at least 18 years with diabetes (type 1 or type 2: not only during pregnancy)

- Adults aged at least 18 years involved in the daily care of an adult (18 years or older) with diabetes (type 1 or type 2)

- General practitioners who personally treat at least 5 adults (18 years or older) with diabetes per month and initiate oral medication

- Diabetes specialists (endocrinologists/diabetologists) who personally treat at least 50 adults (18 years or older) with diabetes per month and prescribe oral medication, insulin or other injectable diabetes medications

- Diabetes educators (diabetes nurses/dieticians/other non-physician healthcare professionals) providing care for at least 5 adults (18 years or older) with diabetes per month

- Participants must have access to the internet, either at home or at a location convenient to them, or be able to attend a face-to-face or telephone interview, to participate in the survey

- Provision of informed consent before the start of any study-related activities

Exclusion Criteria:

- Individuals aged below 18 years and/or diagnosed with diabetes less than 12 months ago

- Inability to understand and comply with written and verbal instructions

Study Design


Intervention

Other:
No treatment given
Three separate survey questionnaires, one for each of the three diabetes groups. Each questionnaire is composed of multiple items including pre-coded (multiple choice) questions, dichotomous (yes/no) questions and rating scales.

Locations

Country Name City State
Algeria Novo Nordisk Investigational Site Algiers
Canada Novo Nordisk Investigational Site Mississauga
China Novo Nordisk Investigational Site Beijing Beijing
Denmark Novo Nordisk Investigational Site Copenhagen S
France Novo Nordisk Investigational Site Paris La défense cedex
Germany Novo Nordisk Investigational Site Mainz
India Novo Nordisk Investigational Site Bangalore
Italy Novo Nordisk Investigational Site Rome
Japan Novo Nordisk Investigational Site Tokyo
Mexico Novo Nordisk Investigational Site Mexico City
Netherlands Novo Nordisk Investigational Site Alphen a/d Rijn
Poland Novo Nordisk Investigational Site Warszawa
Russian Federation Novo Nordisk Investigational Site Moscow
Spain Novo Nordisk Investigational Site Madrid
Turkey Novo Nordisk Investigational Site Istanbul
United Kingdom Novo Nordisk Investigational Site Crawley
United States Novo Nordisk Investigational Site Princeton New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Algeria,  Canada,  China,  Denmark,  France,  Germany,  India,  Italy,  Japan,  Mexico,  Netherlands,  Poland,  Russian Federation,  Spain,  Turkey,  United Kingdom, 

References & Publications (6)

Funnell M. Beyond the data: moving towards a new DAWN in diabetes. Diabet Med. 2013 Jul;30(7):765-6. doi: 10.1111/dme.12244. — View Citation

Holt RI, Nicolucci A, Kovacs Burns K, Escalante M, Forbes A, Hermanns N, Kalra S, Massi-Benedetti M, Mayorov A, Menéndez-Torre E, Munro N, Skovlund SE, Tarkun I, Wens J, Peyrot M; DAWN2 Study Group.. Diabetes Attitudes, Wishes and Needs second study (DAWN — View Citation

Kovacs Burns K, Nicolucci A, Holt RI, Willaing I, Hermanns N, Kalra S, Wens J, Pouwer F, Skovlund SE, Peyrot M; DAWN2 Study Group.. Diabetes Attitudes, Wishes and Needs second study (DAWN2™): cross-national benchmarking indicators for family members livin — View Citation

Nicolucci A, Kovacs Burns K, Holt RI, Comaschi M, Hermanns N, Ishii H, Kokoszka A, Pouwer F, Skovlund SE, Stuckey H, Tarkun I, Vallis M, Wens J, Peyrot M; DAWN2 Study Group.. Diabetes Attitudes, Wishes and Needs second study (DAWN2™): cross-national bench — View Citation

Peyrot M, Burns KK, Davies M, Forbes A, Hermanns N, Holt R, Kalra S, Nicolucci A, Pouwer F, Wens J, Willaing I, Skovlund SE. Diabetes Attitudes Wishes and Needs 2 (DAWN2): a multinational, multi-stakeholder study of psychosocial issues in diabetes and per — View Citation

Peyrot M, Egede LE, Campos C, Cannon AJ, Funnell MM, Hsu WC, Ruggiero L, Siminerio LM, Stuckey HL. Ethnic differences in psychological outcomes among people with diabetes: USA results from the second Diabetes Attitudes, Wishes, and Needs (DAWN2) study. Cu — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Self-reported health and Quality of Life (QoL) (measured by the study questionnaire) Day 1
Secondary Psychological well-being of people with diabetes and family members measured by the study questionnaire Day 1
Secondary Diabetes distress of people with diabetes and family members measured by the study questionnaire Day 1
Secondary Self-reported self-management of people with diabetes measured by the study questionnaire Day 1
Secondary Family support behaviours reported by people with diabetes and family members measured by the study questionnaire Day 1
Secondary Patient-centred diabetes care reported by people with diabetes and health care professionals measured by the study questionnaire Day 1
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2