Clinical Trials Logo
  1. Home
  2. Diabetes Mellitus, Type 2
  3. NCT01628341
  4. Details
NCT01628341 Clinical Trial

French Observational Survey to Assess Hypoglycaemia in Insulin-treated Diabetic Patients

Diabetes Mellitus, Type 2 Clinical Trial

— DIALOG  

Official title:
French Observational Survey to Assess Hypoglycaemia in Insulin-treated Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01628341
Other study ID # INS-3988
Secondary ID U1111-1131-8540
Status Completed
Phase N/A
First received June 22, 2012
Last updated January 18, 2017
Start date May 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

This non-interventional study is conducted in Europe. The study is both retrospective and prospective.

The purpose of the study is to assess the frequency of hypoglycaemia (low blood glucose) in insulin-treated patients with type 1 and type 2 diabetes.

Recruitment information / eligibility
Status Completed
Enrollment 4424
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:

- Patients with Type 1 or Type 2 Diabetes Mellitus

- Patients treated by insulin for at least 12 months

- Patients able to perform capillary self-monitoring plasma glucose (SMPG) measurements

- Patients able to complete the questionnaires

- Patients who have accepted to participate to the survey (signature of an information notice)

Exclusion Criteria:

- Patients with Type 2 Diabetes Mellitus not treated with insulin

- Females who are currently pregnant or lactating or who were pregnant during the previous year

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• insulin
Patients will be asked to complete 2 self-assessment questionnaires

Locations
Country Name City State
France Novo Nordisk Investigational Site Paris La défense cedex

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

France, 

References & Publications (1)

Cariou B, Fontaine P, Eschwege E, Lièvre M, Gouet D, Huet D, Madani S, Lavigne S, Charbonnel B. Frequency and predictors of confirmed hypoglycaemia in type 1 and insulin-treated type 2 diabetes mellitus patients in a real-life setting: results from the DI — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of insulin-treated patients experiencing at least one hypoglycaemia (severe/non-severe) During the one-month follow-up after inclusion in study
Secondary Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia During the last 12 months before inclusion in study
Secondary Percentage of insulin-treated patients experiencing at least one severe hypoglycaemia During the one-month follow-up after inclusion in study
Secondary Percentage of insulin-treated patients experiencing at least one non-severe symptomatic hypoglycaemia During the one-month follow-up after inclusion in study
Secondary Percentage of insulin-treated patients experiencing at least one asymptomatic hypoglycaemia During the one-month follow-up after inclusion in study
Secondary Percentage of insulin-treated patients experiencing at least one hypoglycaemia (overall/severe/non-severe) During the one-month follow-up after inclusion in study
Secondary Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia During the last 12 months before inclusion in study
Secondary Rate of episodes (event/patient/month) in insulin-treated patients of severe hypoglycaemia During the one-month follow-up after inclusion in study
Secondary Rate of episodes (event/patient/month) in insulin-treated patients of non-severe symptomatic hypoglycaemia episodes During the one-month follow-up after inclusion in study
Secondary Rate of episodes (event/patient/month) in insulin-treated patients of asymptomatic hypoglycaemia episodes During the one-month follow-up after inclusion in study
Secondary Overall/severe/non-severe hypoglycaemia episodes (event/patient/month) During the one-month follow-up after inclusion in study
Secondary Extra diagnostic tests carried out (number of extra self-monitoring plasma glucose (SMPG) test following the episode) During the one-month follow-up after inclusion in study
Secondary Additional consultations to a specialist and/or general practitioner (GP), visit to emergency department, hospitalizations, transportation and assistance of a care-giver During the one-month follow-up after inclusion in study
Secondary Change in planned daily activities; sleep, food consumption, physical activities (sport), driving, social life During the one-month follow-up after inclusion in study
Secondary Change in planned daily activities; work: effectiveness, missing hours or days for sick leave During the one-month follow-up after inclusion in study
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 NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
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 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

External Links