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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
  Purpose

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).


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: NN1250
Drug: sitagliptin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting plasma glucose profiles [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

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: NN1250 Drug: NN1250
NN1250 injected under the skin once daily for 26 weeks. The doses will be individually adjusted
Active Comparator: Sitagliptin Drug: sitagliptin
Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046110

  Show 54 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Marianne Willert Novo Nordisk
Study Director: Anne Engstrøm Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01046110     History of Changes
Other Study ID Numbers: NN1250-3580, U1111-1111-7126
Study First Received: January 8, 2010
Last Updated: September 22, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Canada: The Biologics and Genetic Therapies Directorate (BGTD)
India: Ministry of Health
Mexico: COFEPRIS Federal Comission for the Protection of Sanitary Risks
South Africa: Medicines Control Council
Turkey: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013