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:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00469092
First received: May 3, 2007
Last updated: June 15, 2012
Last verified: June 2012
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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: | 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:
Drug Information available for:
Metformin
Metformin hydrochloride
Insulin human
Glimepiride
Insulin aspart
Insulin glargine
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.
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, Argentina, C1405CWB | |
| Austria | |
| Traisen, Austria, 3160 | |
| Czech Republic | |
| Hradec Kralove, Czech Republic | |
| France | |
| La Rochelle, France | |
| India | |
| Karnal, Haryana, India, 132001 | |
| Malaysia | |
| Kota Bharu, Kelantan, Malaysia | |
| Mexico | |
| Guadalajara, Mexico, 44600 | |
| Netherlands | |
| Rotterdam, Netherlands, 3021 HC | |
| Philippines | |
| Quezon City, Philippines | |
| Poland | |
| Zabrze, Poland | |
| Romania | |
| Bucharest, Romania | |
| South Africa | |
| Brits, North West, South Africa, 0250 | |
| Spain | |
| Madrid, Spain, 28040 | |
| Sweden | |
| Stockholm, Sweden | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Pernille Gad, MSc | Novo Nordisk |
More Information
Additional Information:
No publications provided by Novo Nordisk
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novo Nordisk |
| 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: | June 15, 2012 |
| 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 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 June 18, 2013