A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes (BOOST™)
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01059812
First received: January 29, 2010
Last updated: May 18, 2011
Last verified: May 2011
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Purpose
This trial is conducted in Asia and Japan. The aim of this clinical trial is to compare NN5401 with biphasic insulin aspart 30 in patients with type 2 diabetes not optimally controlled on once or twice daily insulin with or without metformin.
| 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 Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes (BOOST™: INTENSIFY ALL) |
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:
- Plasma glucose profile [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
- Number of hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
- Change in body weight [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 424 |
| Study Start Date: | February 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: NN5401
NN5401 injected subcutaneously (under the skin) with the breakfast meal and main evening meal. The dose will be individually adjusted.
|
| Active Comparator: B |
Drug: biphasic insulin aspart 30
Biphasic insulin aspart (BIAsp) 30 injected subcutaneously (under the skin) with the breakfast meal and main evening meal. The dose will be individually adjusted.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ages eligible for study: 18 years and older, for Japan and Taiwan: minimum age is 20 years.
- Type 2 diabetes mellitus for at least 6 months
- Treatment with basal human or analogue insulin once or twice a day with or without metformin for at least 3 months or treatment with premixed human or analogue insulin, or self-mixed insulin regimen containing 20-40% fast/rapid-acting component once or twice a day with or without metformin for at least 3 months
- HbA1c 7.0-10.0 % (both inclusive)
- BMI (Body Mass index) below or equal to 35.0 kg/m2
Exclusion Criteria:
- Treatment with oral antidiabetic drugs (except metformin) within the last 8 weeks prior to trial start
- Treatment with thiazolidinedione or GLP-1 receptor agonists within 3 months prior to trial start
- 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: NCT01059812
Locations
| Hong Kong | |
| Hong Kong, Hong Kong | |
| Japan | |
| Koriyama-shi, Japan, 963 8851 | |
| Korea, Republic of | |
| Incheon, Korea, Republic of, 400-103 | |
| Malaysia | |
| Johor Bahru, Malaysia, 80100 | |
| Taiwan | |
| Taichung, Taiwan, 404 | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Lise Sylvest Helledi, M.Sc, Ph.D | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01059812 History of Changes |
| Other Study ID Numbers: | NN5401-3597, U1111-1111-7210, 101040 |
| Study First Received: | January 29, 2010 |
| Last Updated: | May 18, 2011 |
| Health Authority: | Hong Kong: Department of Health Japan: Ministry of Health, Labour and Welfare (MHLW) Malaysia: National Pharmaceutical Control Bureau South Korea: Korea Food and Drug Administration (KFDA) Taiwan: Department of Health |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin aspart |
Insulin Insulin, NPH Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013