Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Comparison of the Efficacy and Safety of Step-wise Addition of Short Acting Insulin Analogue Insulin Aspart to Once Daily Insulin Detemir and Oral Anti-diabetic Treatment in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537303
• Other study ID #: NN304-1833
• Secondary ID: 2007-000123-18
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2007
• Last updated: November 20, 2014
• Start date: October 2007
• Est. completion date: March 2009

Study information

• Verified date: November 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Pharmacological Committee, Ministry of HealthSouth Africa: Medicines Control CouncilSpain: Spanish Agency for MedicinesSweden: Medical Products AgencySerbia: Medicines and Medical Devices Agency of SerbiaUnited Kingdom: Medicines and Healthcare Products RegulatoryUnited States: Food and Drug AdministrationNorway: Norwegian Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Finland: Finnish Medicines AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe, Africa and the United States of America (USA).

The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus for more than 6 months

• HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening)

• BMI (Body Mass Index) less than 40 kg/m2

• Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily)

• Treatment with one to 3 OADs

Exclusion Criteria:

• Known or suspected allergy to trial products or related products

• Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks

• Previous participation in any trial including this for the last 6 months

• Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin detemir
Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)
• insulin aspart
Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin)
• insulin aspart
Administered 1 - 3 times daily, at largest meals, injection s.c. (under the skin)

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Asheville	North Carolina
United States	Novo Nordisk Clinical Trial Call Center	Athens	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Dayton	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Greer	South Carolina
United States	Novo Nordisk Clinical Trial Call Center	Houston	Texas
United States	Novo Nordisk Clinical Trial Call Center	Idaho Falls	Idaho
United States	Novo Nordisk Clinical Trial Call Center	Kettering	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Lawrenceville	New Jersey
United States	Novo Nordisk Clinical Trial Call Center	Miami	Florida
United States	Novo Nordisk Clinical Trial Call Center	Midland	Texas
United States	Novo Nordisk Clinical Trial Call Center	Milwaukee	Wisconsin
United States	Novo Nordisk Clinical Trial Call Center	Mission Viejo	California
United States	Novo Nordisk Clinical Trial Call Center	Norfolk	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Richmond	Virginia
United States	Novo Nordisk Clinical Trial Call Center	Richmond	Virginia
United States	Novo Nordisk Clinical Trial Call Center	San Antonio	Texas
United States	Novo Nordisk Clinical Trial Call Center	Tacoma	Washington
United States	Novo Nordisk Clinical Trial Call Center	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Denmark,  Finland,  Former Serbia and Montenegro,  Netherlands,  Norway,  Russian Federation,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated Haemoglobin A1c (HbA1c)	Analysed for the full analysis set.	week 36	No
Primary	Glycosylated Haemoglobin A1c (HbA1c)	Measured for the Per Protocol analysis set.	week 36	No
Secondary	Hypoglycaemic Episodes	Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.	Weeks 0-36	No
Secondary	Biochemistry: Serum Alanine Aminotransferase	Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory.	week 36	No
Secondary	Haematology: Haemoglobin Measured in Blood	Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory.	week 36	No
Secondary	Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide	High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory.	week 36	No

External Links

•   Clinical Trials at Novo Nordisk