Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes (BOOST™)
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01009580
First received: November 5, 2009
Last updated: September 20, 2011
Last verified: September 2011
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Purpose
This trial is conducted in Asia, Europe and Oceania. The aim of this clinical trial is compare NN5401 with biphasic insulin aspart 30 in subjects with type 2 diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: NN5401 Drug: biphasic insulin aspart 30 |
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, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Twice Daily vs. Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Both With or Without Metformin, With or Without DPP-4 Inhibitor, With or Without Pioglitazone in Subjects With Type 2 Diabetes (BOOST™: Intensify Premix 1) |
Resource links provided by NLM:
Drug Information available for:
Insulin human
Pioglitazone
Pioglitazone hydrochloride
Insulin aspart
U.S. FDA Resources
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 profile [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 384 |
| Study Start Date: | November 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: NN5401
NN5401 injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose will be individually adjusted. Subjects will continue their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone.
|
| Active Comparator: B |
Drug: biphasic insulin aspart 30
Biphasic insulin aspart 30 injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose will be individually adjusted. Subjects will continue their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone.
|
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
- Ongoing daily treatment with premixed human or analogue insulin or self-mixed insulin regimen, containing fast/rapid-acting component once or twice a day with or without metformin, SU, glinides, alpha-glucosidase inhibitor, DPP-4 inhibitor and pioglitazone for at least 3 months
- HbA1c: 7.0 - 10.0% (both inclusive)
- Body Mass Index (BMI) below or equal to 40.0 kg/m2
Exclusion Criteria:
- Treatment with other insulin regimens than those listed in key inclusion criterion no. 2 within 3 months
- Treatment with rosiglitazone or GLP-1 receptor agonists within 3 months
- 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 according to local requirements
- Cancer and medical history of cancer
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01009580
Locations
| Australia, Victoria | |
| Melbourne, Victoria, Australia, 3004 | |
| Denmark | |
| København, Denmark, 2400 | |
| Finland | |
| Oulu, Finland, 90100 | |
| India | |
| New Delhi, India, 110044 | |
| Malaysia | |
| Cheras, Malaysia, 56000 | |
| Poland | |
| Bydgoszcz, Poland, 85-822 | |
| Sweden | |
| Malmö, Sweden, 211 52 | |
| Taiwan | |
| Chiayi, Taiwan, 600 | |
| Thailand | |
| Bangkok, Thailand, 10110 | |
| Turkey | |
| Istanbul, Turkey, 34890 | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Jens Ahlefeldt-Laurvigen, M.Sc. Pharm. | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01009580 History of Changes |
| Other Study ID Numbers: | NN5401-3592, 2008-005768-15, U1111-1111-8545 |
| Study First Received: | November 5, 2009 |
| Last Updated: | September 20, 2011 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency India: Ministry of Health Malaysia: National Pharmaceutical Control Bureau Poland: Ministry of Health Sweden: Medical Products Agency Taiwan: Department of Health, Executive Yuan, R.O.C. Thailand: Ministry of Public Health Turkey: Ministry of Health |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Pioglitazone Insulin aspart Insulin |
Insulin, NPH Dipeptidyl-Peptidase IV Inhibitors Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013