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An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01696266
First received: September 26, 2012
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

This study is conducted in Europe. The aim of the study is to gather information about hypoglycaemia (low blood glucose) among patients with Type 1 or Type 2 diabetes mellitus. The study is both retrospective and prospective.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Other: No treatment given

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of any hypoglycaemic event [ Time Frame: In the 4 weeks prior to and following the baseline visit (Week 0) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in the reported incidence rates of any hypoglycaemia [ Time Frame: In the 4 weeks prior to (Part 1) versus following (Part 2) the baseline visit ] [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic events requiring hospital admission [ Time Frame: In the 6 months prior to and 4 weeks following the baseline visit ] [ Designated as safety issue: No ]
  • Incidence of all severe hypoglycaemic events [ Time Frame: In the 6 months prior to and 4 weeks following the baseline visit ] [ Designated as safety issue: No ]
  • Incidence of probable symptomatic hypoglycaemic events [ Time Frame: In the 4 weeks prior to and following the baseline visit ] [ Designated as safety issue: No ]

Enrollment: 23606
Study Start Date: September 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Insulin-treated patients with diabetes Other: No treatment given
Patients will be asked to complete a two-part patient self-assessment questionnaire (SAQ) comprising a retrospective cross-sectional evaluation (Part 1), and a prospective observational evaluation (Part 2).

  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

Insulin-treated patients with Type 1 or Type 2 diabetes mellitus. Patients should be ambulatory, literate, have used insulin for at least 12 months, and be over 18 years of age to be able to participate in the study.

Criteria

Inclusion Criteria:

  • Patients with Type 1 or Type 2 diabetes mellitus treated with insulin for more than 12 months
  • Patients giving informed consent to participate in the survey

Exclusion Criteria:

  • Non-ambulatory patients
  • Illiterate patients and patients otherwise unable to complete a written survey
  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: NCT01696266

  Hide Study Locations
Locations
Argentina
Prov. de Buenos Aires, Argentina, B1636DSU
Austria
Vienna, Austria, A-1010
Bulgaria
Sofia, Bulgaria, 1407
Canada
Mississauga, Canada, L4W 4XI
Croatia
Zagreb, Croatia, 10 000
Czech Republic
Prague, Czech Republic, 16000
Denmark
Copenhagen S, Denmark, 2300
Finland
Espoo, Finland, FI-02600
Germany
Mainz, Germany, 55127
Hungary
Budapest, Hungary, 1025
India
Bangalore, India, 560001
Israel
Kfar Saba, Israel, 44425
Lebanon
Amman, Lebanon, 11844
Malaysia
Selangor Darul Ehsan, Malaysia
Mexico
Mexico City, Mexico
Netherlands
Alphen a/d Rijn, Netherlands
Poland
Warszawa, Poland, PL-02-274
Romania
Bucharest, Romania, 010031
Russian Federation
Moscow, Russian Federation, 119330
Saudi Arabia
Riyadh, Saudi Arabia, 3542
Serbia
Belgrade, Serbia, 11070
Slovakia
Bratislava, Slovakia, 811 05
Slovenia
Ljubljana, Slovenia, SI-1000
Sweden
Malmö, Sweden, 202 15
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Angele Mongul Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01696266     History of Changes
Other Study ID Numbers: INS-4019, U1111-1132-1910
Study First Received: September 26, 2012
Last Updated: August 6, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Austrian Agency for Health and Food Safety
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Croatia: Ministry of Health and Social Care
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Ministry of Health, Social and Family Affairs
India: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Lebanon: Ministry of Public Health
Malaysia: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Dutch Health Care Inspectorate
Poland: Ministry of Health
Romania: State Institute for Drug Control
Russia: Pharmacological Committee, Ministry of Health
Saudi Arabia: Ministry of Health
Serbia: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Hypoglycemia
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014