Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin
This study has been completed.
Sponsor:
Novo Nordisk
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
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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:
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
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Hide Study LocationsLocations
| United States, Alabama | |
| Novo Nordisk Clinical Trial Call Center | |
| Huntsville, Alabama, United States, 35801 | |
| United States, California | |
| Novo Nordisk Clinical Trial Call Center | |
| Concord, California, United States, 94520 | |
| Novo Nordisk Clinical Trial Call Center | |
| Fresno, California, United States, 93720 | |
| Novo Nordisk Clinical Trial Call Center | |
| Greenbrae, California, United States, 94904 | |
| Novo Nordisk Clinical Trial Call Center | |
| La Jolla, California, United States, 92037 | |
| Novo Nordisk Clinical Trial Call Center | |
| Los Angeles, California, United States, 90017 | |
| Novo Nordisk Clinical Trial Call Center | |
| Mission Hills, California, United States, 91345-1115 | |
| Novo Nordisk Clinical Trial Call Center | |
| Palm Springs, California, United States, 92262 | |
| Novo Nordisk Clinical Trial Call Center | |
| Torrance, California, United States, 90504 | |
| Novo Nordisk Clinical Trial Call Center | |
| Walnut Creek, California, United States, 94598-3347 | |
| Novo Nordisk Clinical Trial Call Center | |
| Walnut Creek, California, United States, 94598 | |
| United States, Colorado | |
| Novo Nordisk Clinical Trial Call Center | |
| Denver, Colorado, United States, 80239-3133 | |
| United States, Florida | |
| Novo Nordisk Clinical Trial Call Center | |
| Clearwater, Florida, United States, 33765 | |
| Novo Nordisk Clinical Trial Call Center | |
| Inverness, Florida, United States, 34452 | |
| Novo Nordisk Clinical Trial Call Center | |
| Kissimmee, Florida, United States, 34741 | |
| Novo Nordisk Clinical Trial Call Center | |
| Miami, Florida, United States, 33125-1655 | |
| Novo Nordisk Clinical Trial Call Center | |
| Miami, Florida, United States, 33135-1687 | |
| Novo Nordisk Clinical Trial Call Center | |
| Miami, Florida, United States, 33186 | |
| Novo Nordisk Clinical Trial Call Center | |
| Ocala, Florida, United States, 34471 | |
| Novo Nordisk Clinical Trial Call Center | |
| Ponte Vedra, Florida, United States, 32081 | |
| Novo Nordisk Clinical Trial Call Center | |
| Tampa, Florida, United States, 33603 | |
| United States, Georgia | |
| Novo Nordisk Clinical Trial Call Center | |
| Decatur, Georgia, United States, 30033 | |
| Novo Nordisk Clinical Trial Call Center | |
| Roswell, Georgia, United States, 30076 | |
| United States, Illinois | |
| Novo Nordisk Clinical Trial Call Center | |
| Chicago, Illinois, United States, 60611 | |
| Novo Nordisk Clinical Trial Call Center | |
| Chicago, Illinois, United States, 60624 | |
| Novo Nordisk Clinical Trial Call Center | |
| Springfield, Illinois, United States, 62704 | |
| United States, Indiana | |
| Novo Nordisk Clinical Trial Call Center | |
| Huntington, Indiana, United States, 46750-1404 | |
| United States, Iowa | |
| Novo Nordisk Clinical Trial Call Center | |
| Council Bluffs, Iowa, United States, 51501-3605 | |
| Novo Nordisk Clinical Trial Call Center | |
| Des Moines, Iowa, United States, 50314-2610 | |
| United States, Kentucky | |
| Novo Nordisk Clinical Trial Call Center | |
| Paduch, Kentucky, United States, 42003 | |
| United States, Louisiana | |
| Novo Nordisk Clinical Trial Call Center | |
| Metairie, Louisiana, United States, 70002 | |
| United States, Michigan | |
| Novo Nordisk Clinical Trial Call Center | |
| Livonia, Michigan, United States, 48152-3501 | |
| Novo Nordisk Clinical Trial Call Center | |
| Troy, Michigan, United States, 48085-5524 | |
| United States, Mississippi | |
| Novo Nordisk Clinical Trial Call Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, New Mexico | |
| Novo Nordisk Clinical Trial Call Center | |
| Albuquerque, New Mexico, United States, 87108 | |
| United States, New York | |
| Novo Nordisk Clinical Trial Call Center | |
| West Seneca, New York, United States, 14224 | |
| United States, Oklahoma | |
| Novo Nordisk Clinical Trial Call Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Novo Nordisk Clinical Trial Call Center | |
| Pittsburgh, Pennsylvania, United States, 15224-2215 | |
| United States, South Carolina | |
| Novo Nordisk Clinical Trial Call Center | |
| Charleston, South Carolina, United States, 29401 | |
| United States, Texas | |
| Novo Nordisk Clinical Trial Call Center | |
| Corpus Christi, Texas, United States, 78404 | |
| Novo Nordisk Clinical Trial Call Center | |
| El Paso, Texas, United States, 79925 | |
| Novo Nordisk Clinical Trial Call Center | |
| El Paso, Texas, United States, 79905-2709 | |
| Novo Nordisk Clinical Trial Call Center | |
| Houston, Texas, United States, 77070 | |
| Novo Nordisk Clinical Trial Call Center | |
| Sugar Land, Texas, United States, 77478 | |
| Novo Nordisk Clinical Trial Call Center | |
| Tomball, Texas, United States, 77375 | |
| United States, Utah | |
| Novo Nordisk Clinical Trial Call Center | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Virginia | |
| Novo Nordisk Clinical Trial Call Center | |
| Virginia Beach, Virginia, United States, 23454 | |
| United States, Washington | |
| Novo Nordisk Clinical Trial Call Center | |
| Spokane, Washington, United States, 99208 | |
| Argentina | |
| Buenos Aires, Argentina, C1449AAD | |
| Canada, British Columbia | |
| Surrey, British Columbia, Canada, V4A 2H9 | |
| India | |
| Hyderabad, India, 500 001 | |
| Mexico | |
| Mexico City, Mexico, 11850 | |
| South Africa | |
| Umhlanga, South Africa, 4320 | |
| Turkey | |
| Denizli, Turkey | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Marianne Willert | Novo Nordisk |
| Study Director: | Anne Engstrøm | Novo Nordisk |
More Information
Additional Information:
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