Clinical Trials Logo
  1. Home
  2. Diabetes Mellitus, Type 2
  3. NCT00806858
  4. Details
NCT00806858 Clinical Trial

Observational Study of NovoPen® 4 on Treatment Satisfaction of Insulin Therapy in Type 1 or Type 2 Subjects With Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
NovoPen®4 Clinical Experience Programme: A Multicentre, Observational Study of NovoPen®4 on Treatment Satisfaction of Insulin Therapy in Type 1 or Type 2 Subjects With Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00806858
Other study ID # MS236-3663
Secondary ID
Status Completed
Phase N/A
First received December 10, 2008
Last updated November 22, 2016
Start date November 2008
Est. completion date July 2009

Study information
Verified date November 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational

Clinical Trial Summary

This study is conducted in Asia. The aim of this observational study is to evaluate subjects' treatment satisfaction and to evaluate subjects' preference of pen device and the incidence of clinical technical complains while using NovoPen® 4 under normal clinical practice conditions.

Recruitment information / eligibility
Status Completed
Enrollment 526
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Any subject with Type 1 or Type 2 diabetes and accepting to use NovoPen® 4. The selection will be at the discretion of the individual physician.

- A study specific signed informed consent must be signed by each subject before any study-related activities or information is collected, if required by local regulations

Exclusion Criteria:

- Subjects who are unlikely to comply with the protocol, e.g., unwillingness to cooperate, inability to return for the final visit

- Subjects with known or suspected allergy to any insulin or any of its excipients

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• NovoPen® 4
Insulin administration by means of a NovoPen® 4 pen device

Locations
Country Name City State
China Novo Nordisk Investigational Site Beijing Beijing

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

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The change in subjects' satisfaction with insulin therapy, measured by change from visit 1 to visit 2 in subject treatment satisfaction scores on the DTSQ (Diabetes Treatment Satisfaction Questionnaire) 3 months No
Secondary Subjects' device preference 3 months No
Secondary Subjects' NovoPen® 4 evaluation 3 months No
Secondary Number of clinical technical complaints 3 months Yes
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 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 NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
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