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Sponsored by: |
Novo Nordisk |
Information provided by: | Novo Nordisk |
ClinicalTrials.gov Identifier: | NCT00611884 |
This trial is conducted in Africa, Asia and North America.
The aim of the trial is to compare two NN1250 formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes
Condition | Intervention | Phase |
Diabetes Mellitus, Type 2 |
Drug: insulin glargine Drug: metformin Drug: NN1250 |
Phase II |
MedlinePlus related topics: | Diabetes |
ChemIDplus related topics: | Insulin Insulin glargine Metformin Metformin hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy Comparison of Two NN1250 Formulations and Insulin Glargine All in Combination With Metformin in Insulin Naive Subjects With Type 2 Diabetes, Measured by HbA1c After 16 Weeks of Treatment |
Estimated Enrollment: | 236 |
Study Start Date: | January 2008 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental |
Drug: metformin
Tablets, 1500-2000 mg/day
Drug: NN1250
Formulation 1: Treat-to-target dose titration scheme, s.c. injection, once daily
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B: Experimental |
Drug: metformin
Tablets, 1500-2000 mg/day
Drug: NN1250
Formulation 2: Treat-to-target dose titration scheme, s.c. injection, once daily
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C: Experimental |
Drug: metformin
Tablets, 1500-2000 mg/day
Drug: NN1250
Formulation 1: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly
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D: Active Comparator |
Drug: insulin glargine
Treat-to-target dose titration scheme, s.c. injection.
Drug: metformin
Tablets, 1500-2000 mg/day
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
Novo Nordisk Clinical Trial Call Center | |||||
Los Angeles, California, United States, 90057 | |||||
Novo Nordisk Clinical Trial Call Center | |||||
Redlands, California, United States, 92374 | |||||
Novo Nordisk Clinical Trial Call Center | |||||
Spring Valley, California, United States, 91978 | |||||
United States, Florida | |||||
Novo Nordisk Clinical Trial Call Center | |||||
Jacksonville, Florida, United States, 32204 | |||||
United States, Idaho | |||||
Novo Nordisk Clinical Trial Call Center | |||||
Idaho Falls, Idaho, United States, 83404-7542 | |||||
United States, Illinois | |||||
Novo Nordisk Clinical Trial Call Center | |||||
Chicago, Illinois, United States, 60607 | |||||
United States, North Carolina | |||||
Novo Nordisk Clinical Trial Call Center | |||||
Greensboro, North Carolina, United States, 27401-1211 | |||||
United States, Oregon | |||||
Novo Nordisk Clinical Trial Call Center | |||||
Medford, Oregon, United States, 97504 | |||||
United States, South Carolina | |||||
Novo Nordisk Clinical Trial Call Center | |||||
Simpsonville, South Carolina, United States, 29681-3237 | |||||
United States, Tennessee | |||||
Novo Nordisk Clinical Trial Call Center | |||||
Kingsport, Tennessee, United States, 37660 | |||||
United States, Texas | |||||
Novo Nordisk Clinical Trial Call Center | |||||
Dallas, Texas, United States, 75230 | |||||
Novo Nordisk Clinical Trial Call Center | |||||
San Antonio, Texas, United States, 78229 | |||||
United States, Virginia | |||||
Novo Nordisk Clinical Trial Call Center | |||||
Virginia Beach, Virginia, United States, 23462 | |||||
United States, Washington | |||||
Novo Nordisk Clinical Trial Call Center | |||||
Renton, Washington, United States, 98057 | |||||
United States, Wisconsin | |||||
Novo Nordisk Clinical Trial Call Center | |||||
Milwaukee, Wisconsin, United States, 53209 | |||||
Canada, Ontario | |||||
Cambridge, Ontario, Canada, N1R 7L6 | |||||
Toronto, Ontario, Canada, M5T 3L9 | |||||
Etobicoke, Ontario, Canada, M9R 4E1 | |||||
India, Tamilnadu | |||||
Vellore, Tamilnadu, India, 632004 | |||||
South Africa, Gauteng | |||||
Johannesburg, Gauteng, South Africa, 2001 |
Novo Nordisk |
Study Director: | Benedikte J. Lertoft, DVM | Novo Nordisk A/S |
Clinical Trials at Novo Nordisk 
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Responsible Party: | Novo Nordisk A/S ( Public Access to Clinical Trials ) |
Study ID Numbers: | NN1250-1836, EudraCT No: 2007-002475-13 |
First Received: | January 29, 2008 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00611884 |
Health Authority: | India: Ministry of Health; South Africa: Medicines Control Council; United States: Institutional Review Board; Canada: The Biologics and Genetic Therapies Directorate (BGTD) |
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