Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine (BOOST®)
This study is ongoing, but not recruiting participants.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01680341
First received: August 31, 2012
Last updated: February 6, 2013
Last verified: February 2013
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Purpose
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).
The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: IDegAsp |
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 Trial Comparing the Efficacy and Safety of Two Different Titration Algorithms for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine (BOOST®: SIMPLE vs. STEPWISE) |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Change from baseline in HbA1c (glycosylated haemoglobin) (%) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
- Proportion of subjects with HbA1c below 7.0% [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
- Proportion of subjects with HbA1c below 7.0% without confirmed hypoglycaemic episodes during the last 12 weeks of treatment or within 7 days from last randomised treatment including only subjects exposed for at least 12 weeks [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
- Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Weeks 0-28 ] [ Designated as safety issue: No ]
- Number of treatment emergent confirmed hypoglycaemic episodes [ Time Frame: Weeks 0-27 ] [ Designated as safety issue: No ]
- Number of treatment emergent confirmed hypoglycaemic episodes in the maintenance period [ Time Frame: From week 16 to end of trial including follow-up (week 27) ] [ Designated as safety issue: No ]
- Number of treatment emergent nocturnal (00:01-05:59) confirmed hypoglycaemic episodes [ Time Frame: Weeks 0-27 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 270 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: IDegAsp BID (twice daily) simple titration |
Drug: IDegAsp
Twice weekly self-titration at intervals of 3-4 days, based upon a single pre-breakfast and pre-dinner SMPG (self-measured plasma glucose) value. For subcutaneous (s.c., under the skin) administration.
|
| Experimental: IDegAsp BID (twice daily) stepwise titration |
Drug: IDegAsp
Once weekly self-titration based upon the lowest of 3 pre-breakfast and 3 pre-dinner SMPG (self-measured plasma glucose) values. For subcutaneous (s.c., under the skin) administration.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to Visit 2 (randomisation)
- Currently treated with IGlar (Insulin Glargine) and up to 3 oral antidiabetic drugs (OADs) (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). All antidiabetic treatments should have been ongoing for at least 12 weeks prior to Visit 2 (randomisation) and doses should have been stable in this period of time
- Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive) by central laboratory analysis
- Body mass index (BMI) below or equal to 40 kg/m^2
Exclusion Criteria:
- Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)
- Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)
- Uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator
- Life-threatening disease (e.g. cancer)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680341
Show 34 Study Locations
Show 34 Study LocationsSponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Sophie Leonie Chubb | Novo Nordisk |
| Study Director: | Kirsten Jøns | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01680341 History of Changes |
| Other Study ID Numbers: | NN5401-3941, 2012-000373-23, U1111-1127-4114 |
| Study First Received: | August 31, 2012 |
| Last Updated: | February 6, 2013 |
| Health Authority: | Algeria: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Malaysia: Medical Research Ethics Committee Turkey: Ministry of Health Drug and Pharmaceutical Department United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin aspart |
Glargine Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013