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Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin (BEGIN™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01046110
First received: January 8, 2010
Last updated: March 26, 2014
Last verified: March 2014

January 8, 2010
March 26, 2014
January 2010
November 2010   (final data collection date for primary outcome measure)
Change in Glycosylated haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
HbA1c change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01046110 on ClinicalTrials.gov Archive Site
Change in Fasting plasma glucose (FPG) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
Fasting plasma glucose profiles [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
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 (insulin degludec) 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
  • Diabetes Mellitus, Type 2
  • Drug: insulin degludec
    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: IDeg OD
    Intervention: Drug: insulin degludec
  • Experimental: DPP-IV inhibitor
    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:

  • Type 2 diabetes (diagnosed clinically) for at least 6 months
  • Ongoing treatment with 1 or 2 of the following OADs (metformin, insulin secretagogue (sulphonylurea or glinides) or pioglitazone) in any combination with unchanged dosing for at least 3 months prior to Visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination)1500 mg or maximum tolerated dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide): minimum half of the maximal daily dose according to local labelling -Pioglitazone: minimum half of the maximal daily dose according to local labelling or maximum tolerated dose
  • Body Mass Index (BMI) below or equal to 40.0 kg/m^2
  • HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis

Exclusion Criteria:

  • Use within the last 3 months prior to Visit 1 of: exenatide, liraglutide, rosiglitazone or acarbose
  • Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
  • Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
  • Cancer and medical history hereof (except basal cell skin cancer or squamous cell skin 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 A/S
Novo Nordisk A/S
Not Provided
Study Director: Marianne Willert Novo Nordisk A/S
Study Director: Anne Engstrøm Novo Nordisk A/S
Novo Nordisk A/S
March 2014

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