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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.
ClinicalTrials.gov Identifier:
First Posted: January 11, 2010
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
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).

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec Drug: sitagliptin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Comparing Efficacy and Safety of NN1250 With Sitagliptin in Insulin Naive Subjects With Type 2 Diabetes (BEGIN™ : EARLY)

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ]
    Change from baseline in HbA1c after 26 weeks of treatment

Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, Week 26 ]
    Change from baseline in FPG after 26 weeks of treatment

Enrollment: 458
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDeg OD Drug: insulin degludec
Injected under the skin once daily for 26 weeks. The doses will be individually adjusted.
Experimental: DPP-IV inhibitor Drug: sitagliptin
Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046110

  Show 93 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01046110     History of Changes
Other Study ID Numbers: NN1250-3580
U1111-1111-7126 ( Other Identifier: WHO )
First Submitted: January 8, 2010
First Posted: January 11, 2010
Results First Submitted: October 19, 2015
Results First Posted: November 18, 2015
Last Update Posted: March 3, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action