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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00537303
First received: September 28, 2007
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin detemir
Drug: insulin aspart
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: week 36 ] [ Designated as safety issue: No ]
    Analysed for the full analysis set.

  • Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: week 36 ] [ Designated as safety issue: No ]
    Measured for the Per Protocol analysis set.


Secondary Outcome Measures:
  • Hypoglycaemic Episodes [ Time Frame: Weeks 0-36 ] [ Designated as safety issue: No ]
    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.

  • Biochemistry: Serum Alanine Aminotransferase [ Time Frame: week 36 ] [ Designated as safety issue: No ]
    Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory.

  • Haematology: Haemoglobin Measured in Blood [ Time Frame: week 36 ] [ Designated as safety issue: No ]
    Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory.

  • Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide [ Time Frame: week 36 ] [ Designated as safety issue: No ]
    High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory.


Enrollment: 296
Study Start Date: October 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Advanced
Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
Drug: insulin detemir
Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)
Drug: insulin aspart
Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin)
Active Comparator: Basic
Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
Drug: insulin detemir
Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)
Drug: insulin aspart
Administered 1 - 3 times daily, at largest meals, injection s.c. (under the skin)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00537303

  Show 29 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Berit Gorsoe Kjeldsen, MSc Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00537303     History of Changes
Other Study ID Numbers: NN304-1833, 2007-000123-18
Study First Received: September 28, 2007
Results First Received: July 16, 2010
Last Updated: September 22, 2011
Health Authority: Russia: Pharmacological Committee, Ministry of Health
South Africa: Medicines Control Council
Spain: Spanish Agency for Medicines
Sweden: Medical Products Agency
Serbia: Medicines and Medical Devices Agency of Serbia
United Kingdom: Medicines and Healthcare Products Regulatory
United States: Food and Drug Administration
Norway: Norwegian Medicines Agency
Netherlands: 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 Agency
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Insulin
Hypoglycemic Agents
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014