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Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01046110
First received: January 8, 2010
Last updated: September 22, 2011
Last verified: September 2011
History of Changes

January 8, 2010
September 22, 2011
January 2010
November 2010   (final data collection date for primary outcome measure)
HbA1c change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01046110 on ClinicalTrials.gov Archive Site
Fasting plasma glucose profiles [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin
A Trial Comparing Efficacy and Safety of NN1250 With Sitagliptin in Insulin Naive Subjects With Type 2 Diabetes (BEGIN™ : EARLY)

This trial will be conducted in Africa, Asia, North America and South America. The aim of this clinical trial is to compare NN1250 with sitagliptin, as add-on to subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: NN1250
    NN1250 injected under the skin once daily for 26 weeks. The doses will be individually adjusted
  • Drug: sitagliptin
    Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks
  • Experimental: NN1250
    Intervention: Drug: NN1250
  • Active Comparator: Sitagliptin
    Intervention: Drug: sitagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
458
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of type 2 diabetes mellitus for at least 6 months
  • Treatment with 1-2 oral antidiabetic drugs (metformin, sulphonylurea, glinides or pioglitazone) for at least three months at an unchanged dose
  • HbA1c between 7.5 - 11.0%
  • Body Mass Index (BMI) below or equal to 40.0 kg/m2

Exclusion Criteria:

  • Treatment with exenatide, liraglutide, rosiglitazone or acarbose in the 3 months before the screening visit is not allowed.
  • Cardiovascular disease within the last 6 months
  • Uncontrolled treated/untreated severe hypertension
  • Recurrent severe hypoglycaemia or hypoglycaemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
  • Cancer and medical history of cancer
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Canada,   India,   Mexico,   South Africa,   Turkey
 
NCT01046110
NN1250-3580, U1111-1111-7126
No
Novo Nordisk
Novo Nordisk
Not Provided
Study Director: Marianne Willert Novo Nordisk
Study Director: Anne Engstrøm Novo Nordisk
Novo Nordisk
September 2011

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