Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes (BEGIN™)
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01006291
First received: October 30, 2009
Last updated: September 20, 2011
Last verified: September 2011
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Purpose
This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 with insulin glargine in patients with type 2 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: NN1250 Drug: insulin glargine |
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 26 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Three-arm, Treat-to-target Trial Comparing Efficacy and Safety of Three Different Dosing Regimens of Either NN1250 or Insulin Glargine With or Without Combination With OAD Treatment, in Subjects With Type 2 Diabetes Mellitus (BEGIN™ : FLEX) |
Resource links provided by NLM:
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:
- Hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
- Self-measured 9-point plasma glucose profiles [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 687 |
| Study Start Date: | November 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: NN1250
NN1250 injected s.c. (under the skin) once daily. The doses will be individually adjusted
|
| Experimental: B |
Drug: NN1250
NN1250 injected s.c. (under the skin) once daily (alternative regimen). The doses will be individually adjusted.
|
| Active Comparator: C |
Drug: insulin glargine
Insulin glargine injected s.c. (under the skin) once daily.The dose will be individually adjusted
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 2 diabetes mellitus for at least 6 months
- Currently treated with oral antidiabetic drugs, treated with insulin or a combination of oral antidiabetic drugs and insulin for at least 3 months
- For patients currently treated with oral antidiabetic drug: HbA1c 7-11%
- For patients currently treated with insulin: HbA1c 7-10%
- Body Mass Index (BMI) below or equal to 40.0 kg/m2
Exclusion Criteria:
- Use GLP-1 receptor agonist (exenatide, liraglutide), rosiglitazone, DPP-IV inhibitors, a-glucosidase-inhibitors within the last 3 months prior to trial start
- Cardiovascular disease, within the last 6 months
- Uncontrolled treated/untreated severe hypertension
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
- Cancer and medical history of cancer hereof
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006291
Locations
| Argentina | |
| Buenos Aires, Argentina, C1425AGC | |
| Finland | |
| Tampere, Finland, FI-33520 | |
| Hungary | |
| Budapest, Hungary, 1041 | |
| India | |
| New Dehli, India, 110024 | |
| Israel | |
| Kfar Saba, Israel, 44281 | |
| Macedonia, The Former Yugoslav Republic of | |
| Skopje, Macedonia, The Former Yugoslav Republic of, 1000 | |
| Malaysia | |
| Putrajaya, Malaysia, 62250 | |
| Mexico | |
| Mexico City, Mexico, 03300 | |
| Norway | |
| Stavanger, Norway, 4005 | |
| Russian Federation | |
| Moscow, Russian Federation, 121356 | |
| Serbia | |
| Belgrade, Serbia, 11000 | |
| South Africa | |
| Johannesburg, Gauteng, South Africa, 1829 | |
| Taiwan | |
| Taipei, Taiwan, 114 | |
| United Kingdom | |
| London, United Kingdom, BT16 1RH | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Lise Brandt, MSc.PhD. | Novo Nordisk |
More Information
Additional Information:
No publications provided by Novo Nordisk
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01006291 History of Changes |
| Other Study ID Numbers: | NN1250-3668, U1111-1111-7084, 2008-005771-10 |
| Study First Received: | October 30, 2009 |
| Last Updated: | September 20, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency Russia: Pharmacological Committee Israel: Israeli Health Ministry Pharmaceutical Administration Finland: Finnish Medicines Agency Norway: Norwegian Medicines Agency Serbia: Medicines and Medical Devices Agency of Serbia India: Ministry of Health Malaysia: Ministry of Health Hungary: National Institute of Pharmacy Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health South Africa: Medicines Control Council Taiwan: Department of Health, Executive Yuan, R.O.C. Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Mexico: National Institute of Public Health, Health Secretariat |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glargine |
Insulin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013