Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes. |
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Condition | Diabetes Diabetes Mellitus, Type 2 |
Intervention | Drug: insulin glargine Drug: insulin degludec Drug: insulin degludec Drug: insulin degludec Drug: metformin |
Phase | Phase 2 |
Sponsor | Novo Nordisk A/S |
Responsible Party | Novo Nordisk A/S |
ClinicalTrials.gov Identifier | NCT00611884 |
First Received | January 29, 2008 |
Last Updated | March 26, 2014 |
Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | January 29, 2008 |
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Last Updated Date | March 26, 2014 |
Start Date | January 2008 |
Estimated Primary Completion Date | August 2008 |
Current Primary Outcome Measures | Change in Glycosylated Haemoglobin (HbA1c) [Time Frame: Week 0, Week 16] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes |
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Official Title | A 16 Week Randomised, Open-labelled, Four-armed, Treat-to-target, Parallel-group Trial Comparing SIBA D Once Daily, SIBA E Once Daily, SIBA D Monday, Wednesday and Friday and Insulin Glargine Once Daily, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment |
Brief Summary | This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: insulin glargine Treat-to-target dose titration scheme, s.c. injection. Drug: insulin degludec Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily Drug: insulin degludec Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily Drug: insulin degludec Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly Drug: metformin Tablets, 1500-2000 mg/day |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 245 |
Estimated Completion Date | August 2008 |
Estimated Primary Completion Date | August 2008 |
Eligibility Criteria | Inclusion Criteria: - Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.) - Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximeum 14 days within the last 3 months) - Treatment with one or two oral anti-diabetic drug (OADs): metformin, sulphonylurea (SU) (or other insulin secretagogue e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to the summary of product characteristics (SPC) or locally approved PI - HbA1c 7.0-11.0 % (both inclusive) - Body Mass Index (BMI) 23-42 kg/m^2 [lb/in^2 x 703] (both inclusive) Exclusion Criteria: - Metformin contraindication according to local practice - Thiazolidinedione (TZD) treatment within previous three months prior to visit 1 - Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) three months prior to randomisation - Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial drug |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Canada, India, South Africa |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00611884 |
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Other Study ID Numbers | NN1250-1836 |
Has Data Monitoring Committee | No |
Information Provided By | Novo Nordisk A/S |
Study Sponsor | Novo Nordisk A/S |
Collaborators | Not Provided |
Investigators | Study Director: Benedikte J. Lertoft, DVM Novo Nordisk A/S |
Verification Date | March 2014 |
Locations[ + expand ][ + ]
Novo Nordisk Clinical Trial Call Center | Los Angeles, California, United States, 90057 |
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Novo Nordisk Clinical Trial Call Center | Redlands, California, United States, 92374 |
Novo Nordisk Clinical Trial Call Center | Spring Valley, California, United States, 91978 |
Novo Nordisk Clinical Trial Call Center | Jacksonville, Florida, United States, 32204 |
Novo Nordisk Clinical Trial Call Center | Idaho Falls, Idaho, United States, 83404-7542 |
Novo Nordisk Clinical Trial Call Center | Chicago, Illinois, United States, 60616 |
Novo Nordisk Clinical Trial Call Center | Chicago, Illinois, United States, 60607 |
Novo Nordisk Clinical Trial Call Center | Springfield, Illinois, United States, 62704 |
Novo Nordisk Clinical Trial Call Center | Greensboro, North Carolina, United States, 27408 |
Novo Nordisk Clinical Trial Call Center | Medford, Oregon, United States, 97504 |
Novo Nordisk Clinical Trial Call Center | Simpsonville, South Carolina, United States, 29681 |
Novo Nordisk Clinical Trial Call Center | Johnson City, Tennessee, United States, 37604 |
Novo Nordisk Clinical Trial Call Center | Dallas, Texas, United States, 75230 |
Novo Nordisk Clinical Trial Call Center | San Antonio, Texas, United States, 78229 |
Novo Nordisk Clinical Trial Call Center | Norfolk, Virginia, United States, 23502 |
Novo Nordisk Clinical Trial Call Center | Renton, Washington, United States, 98057 |
Novo Nordisk Clinical Trial Call Center | Milwaukee, Wisconsin, United States, 53209 |
Canada, Ontario | Etobicoke, Ontario, Canada, M9R 4E1 |
India | Vellore, India, 632004 |
South Africa, Gauteng | Johannesburg, Gauteng, South Africa, 2001 |