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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469092
• Other study ID #: BIASP-1731
• Secondary ID: 2006-003288-29
• Status: Completed
• Phase: Phase 4
• First received: May 3, 2007
• Last updated: October 3, 2014
• Start date: May 2007
• Est. completion date: April 2008

Study information

• Verified date: October 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of MedicinesPoland: Ministry of HealthSerbia: Medicines and Medical Devices Agency of SerbiaSouth Africa: Medicines Control CouncilCzech Republic: State Institute for Drug ControlAustria: Federal Ministry for Health and WomenArgentina: Administracion Nacional de Medicamentos, Alimentos y TecnologiaPhilippines: Bureau of Food and DrugsRomania: National Medicines AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Sweden: Medical Products AgencyMexico: National Council of Science and TechnologyMalaysia: Ministry of HealthIndia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• 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.
• insulin glargine
Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.
• metformin
Tablets, 2550 mcg. Administered once daily.
• glimepiride
Tablets 2 mg. 4, 6 or 8 mg administered once daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Argentina,  Austria,  Czech Republic,  France,  India,  Malaysia,  Mexico,  Netherlands,  Philippines,  Poland,  Romania,  South Africa,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated Haemoglobin A1c (HbA1c)	Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.	After 26 weeks of treatment	No
Secondary	9-point Self-measured Plasma Glucose Profiles	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.	After 26 weeks of treatment	No
Secondary	Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)	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.	After 26 weeks of treatment	No
Secondary	Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)	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.	After 26 weeks of treatment	No
Secondary	Number of Hypoglycaemic Episodes	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.	Weeks 0-26	No
Secondary	Number of Subjects Reporting Treatment Emergent Adverse Events	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.	Weeks 0-26	No

External Links

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