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

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ClinicalTrials.gov Identifier: NCT01696266
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : November 9, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Other: No treatment given

Study Design

Study Type : Observational
Actual Enrollment : 29304 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Actual Study Start Date : September 5, 2012
Primary Completion Date : December 30, 2013
Study Completion Date : December 30, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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).

Outcome Measures

Primary Outcome Measures :
  1. Incidence of any hypoglycaemic event [ Time Frame: In the 4 weeks prior to and following the baseline visit (Week 0) ]

Secondary Outcome Measures :
  1. 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 ]
  2. Incidence of hypoglycaemic events requiring hospital admission [ Time Frame: In the 6 months prior to and 4 weeks following the baseline visit ]
  3. Incidence of all severe hypoglycaemic events [ Time Frame: In the 6 months prior to and 4 weeks following the baseline visit ]
  4. Incidence of probable symptomatic hypoglycaemic events [ Time Frame: In the 4 weeks prior to and following the baseline visit ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696266

  Hide Study Locations
Novo Nordisk Investigational Site
Prov. De Buenos Aires, Argentina, B1636DSU
Novo Nordisk Investigational Site
Vienna, Austria, A-1010
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1407
Novo Nordisk Investigational Site
Mississauga, Canada, L4W 4XI
Novo Nordisk Investigational Site
Zagreb, Croatia, 10 000
Novo Nordisk Investigational Site
Prague, Czechia, 16000
Novo Nordisk Investigational Site
Copenhagen S, Denmark, 2300
Novo Nordisk Investigational Site
Espoo, Finland, FI-02600
Novo Nordisk Investigational Site
Mainz, Germany, 55127
Novo Nordisk Investigational Site
Budapest, Hungary, 1025
Novo Nordisk Investigational Site
Bangalore, India, 560001
Novo Nordisk Investigational Site
Kfar Saba, Israel, 44425
Novo Nordisk Investigational Site
Amman, Lebanon, 11844
Novo Nordisk Investigational Site
Selangor Darul Ehsan, Malaysia
Novo Nordisk Investigational Site
Mexico City, Mexico
Novo Nordisk Investigational Site
Alphen A/d Rijn, Netherlands
Novo Nordisk Investigational Site
Warszawa, Poland, PL-02-274
Novo Nordisk Investigational Site
Bucharest, Romania, 010031
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119330
Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, Saudi Arabia, 3542
Novo Nordisk Investigational Site
Belgrade, Serbia, 11070
Novo Nordisk Investigational Site
Bratislava, Slovakia, 811 05
Novo Nordisk Investigational Site
Ljubljana, Slovenia, SI-1000
Novo Nordisk Investigational Site
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
ClinicalTrials.gov Identifier: NCT01696266     History of Changes
Other Study ID Numbers: INS-4019
U1111-1132-1910 ( Other Identifier: WHO )
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017

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