Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes | RxWiki

Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

Overview[ - collapse ][ - ]

Purpose	This trial is conducted in Africa, Asia, Europe, Oceania and South America. This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: biphasic insulin aspart Drug: insulin glargine Drug: metformin Drug: glimepiride
Phase	Phase 4
Sponsor	Novo Nordisk A/S
Responsible Party	Novo Nordisk A/S
ClinicalTrials.gov Identifier	NCT00469092
First Received	May 3, 2007
Last Updated	December 2, 2013
Last verified	December 2013

Tracking Information[ + expand ][ + ]

First Received Date	May 3, 2007
Last Updated Date	December 2, 2013
Start Date	May 2007
Estimated Primary Completion Date	April 2008
Current Primary Outcome Measures	Glycosylated Haemoglobin A1c (HbA1c) [Time Frame: After 26 weeks of treatment] [Designated as safety issue: No]Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.
Current Secondary Outcome Measures	9-point Self-measured Plasma Glucose Profiles [Time Frame: After 26 weeks of treatment] [Designated as safety issue: No]Glycaemic control measured by 9-point self-measured plasma glucose (SMPG) profiles. The 9 time points for self-measurement during the day were: Before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 AM, and before breakfast the following day. Hypoglycaemia episodes were defined as major or minor. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c) [Time Frame: After 26 weeks of treatment] [Designated as safety issue: No]The number of subjects achieving the treatment target for glycosylated haemoglobin A1c after 26 weeks treatment. The treatment targets were: HbA1c <= 6.5% of haemoglobin and HbA1c < 7% of haemoglobin. Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat) [Time Frame: After 26 weeks of treatment] [Designated as safety issue: No]Subjects assessed the burden, efficacy, symptoms and overall score in the treatment satisfaction questionnaire, Diab MedSat (Diabetes Medication Satisfaction questionnaire). The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. Number of Hypoglycaemic Episodes [Time Frame: Weeks 0-26] [Designated as safety issue: No]Total number of hypoglycaemic episodes experienced in each treatment arm. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL. Number of Subjects Reporting Treatment Emergent Adverse Events [Time Frame: Weeks 0-26] [Designated as safety issue: No]Number of subjects reporting treatment emergent adverse events during the trial (from week 0 to week 26). Adverse events were reported as treatment emergent if they occurred from the date of first insulin trial product administration up to and including the date of last insulin trial product administration.

Descriptive Information[ + expand ][ + ]

Brief Title	Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes
Official Title	A Multi-national, Open-labelled, Randomised, Parallel Group, 4 Week run-in and 26 Weeks Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin naïve Subjects With Type 2 Diabetes
Brief Summary	This trial is conducted in Africa, Asia, Europe, Oceania and South America. This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: biphasic insulin aspart Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements. Drug: insulin glargine Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements. Drug: metformin Tablets, 2550 mcg. Administered once daily. Drug: glimepiride Tablets 2 mg. 4, 6 or 8 mg administered once daily.
Study Arm (s)	Experimental: BIAsp 30 Active Comparator: Glargine

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	480
Estimated Completion Date	April 2008
Estimated Primary Completion Date	April 2008
Eligibility Criteria	Inclusion Criteria: - Type 2 diabetes - Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months - Ongoing stable treatment with metformin for at least 2 months - Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months - Insulin naive - HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values) Exclusion Criteria: - Metformin contraindication according to local practice - TZD (thiazolidinedione) treatment for the last 5 months before trial start - Systemic treatment with any corticosteroid 3 months before trial start - Any disease or condition which according to the Investigator would interfere with the trial
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Argentina, Austria, Czech Republic, France, India, Malaysia, Mexico, Netherlands, Philippines, Poland, Romania, South Africa, Spain, Sweden

Administrative Information[ + expand ][ + ]

NCT Number	NCT00469092
Other Study ID Numbers	BIASP-1731
Has Data Monitoring Committee	No
Information Provided By	Novo Nordisk A/S
Study Sponsor	Novo Nordisk A/S
Collaborators	Not Provided
Investigators	Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Verification Date	December 2013

Locations[ + expand ][ + ]

Argentina	Ciudad Autonoma de Bs As, Argentina, C1405CWB
Austria	Traisen, Austria, 3160
Czech Republic	Hradec Kralove, Czech Republic, 500 05
France	LA ROCHELLE cedex, France, 17019
India, Haryana	Karnal, Haryana, India, 132001
Malaysia	Kota Bharu, Kelantan, Malaysia, 16150
Mexico	Guadalajara, Mexico, 44600
Netherlands	Rotterdam, Netherlands, 3021 HC
Philippines	Quezon City, Philippines, 1102
Poland	Zabrze, Poland, 41-800
Romania	Bucharest, Romania, 020475
South Africa, North West	Brits, North West, South Africa, 0250
Spain	Madrid, Spain, 28040
Sweden	Stockholm, Sweden, 182 88