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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: September 26, 2012
Last updated: August 19, 2016
Last verified: August 2016
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 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: 29304
Study Start Date: September 2012
Study Completion Date: December 2013
Primary Completion Date: December 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).


Ages Eligible for Study:   Child, Adult, Senior
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.

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 identifier: NCT01696266

  Hide Study Locations
Prov. de Buenos Aires, Argentina, B1636DSU
Vienna, Austria, A-1010
Sofia, Bulgaria, 1407
Mississauga, Canada, L4W 4XI
Zagreb, Croatia, 10 000
Czech Republic
Prague, Czech Republic, 16000
Copenhagen S, Denmark, 2300
Espoo, Finland, FI-02600
Mainz, Germany, 55127
Budapest, Hungary, 1025
Bangalore, India, 560001
Kfar Saba, Israel, 44425
Amman, Lebanon, 11844
Selangor Darul Ehsan, Malaysia
Mexico City, Mexico
Alphen a/d Rijn, Netherlands
Warszawa, Poland, PL-02-274
Bucharest, Romania, 010031
Russian Federation
Moscow, Russian Federation, 119330
Saudi Arabia
Riyadh, Saudi Arabia, 3542
Belgrade, Serbia, 11070
Bratislava, Slovakia, 811 05
Ljubljana, Slovenia, SI-1000
Malmö, Sweden, 202 15
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01696266     History of Changes
Other Study ID Numbers: INS-4019  U1111-1132-1910 
Study First Received: September 26, 2012
Last Updated: August 19, 2016
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 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on October 21, 2016