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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: insulin glargine; Drug: biphasic insulin aspart; Drug: metformin; Drug: glimepiride

• Registration Number: NCT00469092
• Lead Sponsor: Novo Nordisk A/S

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 available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-04
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-11-30
• Results First Submitted QC: 2009-11-30
• Results First Posted: 2010-01-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glargine	insulin glargine	-
BIAsp 30	biphasic insulin aspart	-
BIAsp 30	metformin	-
BIAsp 30	glimepiride	-
Glargine	glimepiride	-
Glargine	metformin	-

Primary Outcome Measures

Name	Time	Method
Glycosylated Haemoglobin A1c (HbA1c)	After 26 weeks of treatment	Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
9-point Self-measured Plasma Glucose Profiles	After 26 weeks of treatment	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)	After 26 weeks of treatment	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)	After 26 weeks of treatment	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	Weeks 0-26	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	Weeks 0-26	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.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Stockholm, Sweden