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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00469092
First received: May 3, 2007
Last updated: August 11, 2014
Last verified: August 2014
  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
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Drug: insulin glargine
Drug: metformin
Drug: glimepiride
Phase 4

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 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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: 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.


Enrollment: 469
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 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: metformin
Tablets, 2550 mcg. Administered once daily.
Drug: glimepiride
Tablets 2 mg. 4, 6 or 8 mg administered once daily.
Active Comparator: Glargine 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
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
Brits, North West, South Africa, 0250
Spain
Madrid, Spain, 28040
Sweden
Stockholm, Sweden, 182 88
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00469092     History of Changes
Other Study ID Numbers: BIASP-1731, 2006-003288-29
Study First Received: May 3, 2007
Results First Received: November 30, 2009
Last Updated: August 11, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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
Insulin, Globin Zinc
Glimepiride
Glargine
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Metformin
Insulin Aspart
Biphasic Insulins
Insulin, Long-Acting
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 26, 2014