Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, 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 degludec/insulin aspart Drug: insulin degludec/insulin aspart Drug: biphasic insulin aspart Drug: metformin |
Phase | Phase 2 |
Sponsor | Novo Nordisk A/S |
Responsible Party | Novo Nordisk A/S |
ClinicalTrials.gov Identifier | NCT00613951 |
First Received | January 30, 2008 |
Last Updated | November 7, 2013 |
Last verified | November 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | January 30, 2008 |
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Last Updated Date | November 7, 2013 |
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 NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes |
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Official Title | A 16 Week Randomised, Open Labelled, 3-armed, Parallel Group, Treat-to-target Trial Comparing Twice Daily (BID) Injections of SIAC 30 (B), SIAC 45 (B) and NovoMix®30, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment |
Brief Summary | This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, 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 degludec/insulin aspart Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily Drug: insulin degludec/insulin aspart Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily Drug: biphasic insulin aspart Treat-to-target dose titration scheme, injection s.c., twice daily Drug: metformin Tablets, 1500-2000 mg/daily |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 182 |
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 maximum 14 days within the last 3 months) - Treatment with one or two oral anti-diabetic drugs (OADs): metformin, sulfonylurea, 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 locally approved summary of product characteristics (SPC) - HbA1c, 7.0-11.0 % (both inclusive) - Body Mass Index (BMI), 25.0-37.0 kg/m^2 (both inclusive) Exclusion Criteria: - Metformin contraindication according to local practice - Thiazolidinedione (TZD) treatment within previous 3 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) within 3 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 product |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Finland, France, Germany, Poland, Spain |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00613951 |
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Other Study ID Numbers | NN5401-1792 |
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 | November 2013 |
Locations[ + expand ][ + ]
Finland | Lahti, Finland, 15110 |
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France | Narbonne, France, 11108 |
Germany | Riesa, Germany, 01587 |
Poland | Warszawa, Poland, 02-507 |
Spain | Madrid, Spain, 28034 |