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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

September 28, 2007
September 22, 2011
October 2007
March 2009   (final data collection date for primary outcome measure)
  • 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.
HbA1c [ Time Frame: after 36 weeks ]
Complete list of historical versions of study NCT00537303 on ClinicalTrials.gov Archive Site
  • 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.
  • Adverse events
  • Hypoglycaemic episodes
  • Biochemistry
  • Haematology
  • CV risk markers
Not Provided
Not Provided
 
Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • 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)
  • Drug: insulin aspart
    Administered 1 - 3 times daily, at largest meals, injection s.c. (under the skin)
  • 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.
    Interventions:
    • Drug: insulin detemir
    • Drug: insulin aspart
  • 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.
    Interventions:
    • Drug: insulin detemir
    • Drug: insulin aspart
Meneghini L, Mersebach H, Kumar S, Svendsen AL, Hermansen K. Comparison of 2 intensification regimens with rapid-acting insulin aspart in type 2 diabetes mellitus inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: the step-wise randomized study. Endocr Pract. 2011 Sep-Oct;17(5):727-36. doi: 10.4158/EP10367.OR.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
296
March 2009
March 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Denmark,   Finland,   Former Serbia and Montenegro,   Netherlands,   Norway,   Russian Federation,   South Africa,   Spain,   Sweden,   United Kingdom
 
NCT00537303
NN304-1833, 2007-000123-18
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Berit Gorsoe Kjeldsen, MSc Novo Nordisk A/S
Novo Nordisk A/S
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP