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

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00469092

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	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: biphasic insulin aspart Drug: insulin glargine Drug: metformin Drug: glimepiride	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin Naive Subjects With Type 2 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Insulin beef Glimepiride Insulin aspart Insulin glargine Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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.

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: Yes ]
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: Yes ]
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.

Enrollment:	480
Study Start Date:	May 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BIAsp 30 biphasic insulin aspart 30 + metformin + glimepiride	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. Other Names: BIasp NovoMix 30 NovoLog Mix 70/30 Drug: metformin Tablets, 2550 mcg. Administered once daily Drug: glimepiride tablets 2 mg. 4, 6 or 8 mg administered once daily
Active Comparator: Glargine insulin glargine + metformin + glimepiride	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469092

Locations

Argentina

Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1405CWB
Austria

Traisen, Austria, 3160
Czech Republic

Hradec Kralove, Czech Republic
France

La Rochelle, France
India

Karnal, India, 132001
Malaysia

Kota Bharu, Kelantan, Malaysia
Mexico

Guadalajara, Jalisco, Mexico, 44600
Netherlands

Rotterdam, Netherlands, 3021 HC
Philippines

Quezon City, Philippines
Poland

Zabrze, Poland
Romania

Bucharest, Romania
South Africa

Brits, South Africa, 0205
Spain

Madrid, Spain, 28040
Sweden

Stockholm, Sweden

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Pernille Gad, MSc

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Strojek K, Bebakar WM, Khutsoane DT, Pesic M, Smahelová A, Thomsen HF, Kalra S. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin. 2009 Dec;25(12):2887-94.

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00469092 History of Changes
Other Study ID Numbers:	BIASP-1731, EudraCT No: 2006-003288-29
Study First Received:	May 3, 2007
Results First Received:	November 30, 2009
Last Updated:	July 6, 2010
Health Authority:	France: Afssaps - French Health Products Safety Agency; Spain: Spanish Agency of Medicines; Poland: Ministry of Health; Serbia: Medicines and Medical Devices Agency of Serbia; South Africa: Medicines Control Council; Czech Republic: State Institute for Drug Control; Austria: Federal Ministry for Health and Women; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia; Philippines: Bureau of Food and Drugs; Romania: National Medicines Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Sweden: Medical Products Agency; Mexico: National Council of Science and Technology; Malaysia: Ministry of Health; India: Ministry of Health

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Insulin aspart
Glargine
Insulin
Metformin

Insulin, Long-Acting
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012