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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01696266

Collaborator

(none)

29,304

Enrollment

Locations

15.8

Actual Duration (Months)

1221

Patients Per Site

77.3

Patients Per Site Per Month

Study Details

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	Phase
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 :

Sep 5, 2012

Actual Primary Completion Date :

Dec 30, 2013

Actual Study Completion Date :

Dec 30, 2013

Arms and Interventions

Arm	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).

Arm

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

Incidence of any hypoglycaemic event [In the 4 weeks prior to and following the baseline visit (Week 0)]

Secondary Outcome Measures

Difference in the reported incidence rates of any hypoglycaemia [In the 4 weeks prior to (Part 1) versus following (Part 2) the baseline visit]
Incidence of hypoglycaemic events requiring hospital admission [In the 6 months prior to and 4 weeks following the baseline visit]
Incidence of all severe hypoglycaemic events [In the 6 months prior to and 4 weeks following the baseline visit]
Incidence of probable symptomatic hypoglycaemic events [In the 4 weeks prior to and following the baseline visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Novo Nordisk Investigational Site	Prov. De Buenos Aires	Argentina	B1636DSU
2	Novo Nordisk Investigational Site	Vienna	Austria	A-1010
3	Novo Nordisk Investigational Site	Sofia	Bulgaria	1407
4	Novo Nordisk Investigational Site	Mississauga	Canada	L4W 4XI
5	Novo Nordisk Investigational Site	Zagreb	Croatia	10 000
6	Novo Nordisk Investigational Site	Prague	Czechia	16000
7	Novo Nordisk Investigational Site	Copenhagen S	Denmark	2300
8	Novo Nordisk Investigational Site	Espoo	Finland	FI-02600
9	Novo Nordisk Investigational Site	Mainz	Germany	55127
10	Novo Nordisk Investigational Site	Budapest	Hungary	1025
11	Novo Nordisk Investigational Site	Bangalore	India	560001
12	Novo Nordisk Investigational Site	Kfar Saba	Israel	44425
13	Novo Nordisk Investigational Site	Amman	Lebanon	11844
14	Novo Nordisk Investigational Site	Selangor Darul Ehsan	Malaysia
15	Novo Nordisk Investigational Site	Mexico City	Mexico
16	Novo Nordisk Investigational Site	Alphen A/d Rijn	Netherlands
17	Novo Nordisk Investigational Site	Warszawa	Poland	PL-02-274
18	Novo Nordisk Investigational Site	Bucharest	Romania	010031
19	Novo Nordisk Investigational Site	Moscow	Russian Federation	119330
20	Novo Nordisk Investigational Site	Riyadh	Saudi Arabia	3542
21	Novo Nordisk Investigational Site	Belgrade	Serbia	11070
22	Novo Nordisk Investigational Site	Bratislava	Slovakia	811 05
23	Novo Nordisk Investigational Site	Ljubljana	Slovenia	SI-1000
24	Novo Nordisk Investigational Site	Malmö	Sweden	202 15