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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: January 5, 2017
Last verified: January 2017
  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
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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 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   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Show 69 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00469092     History of Changes
Other Study ID Numbers: BIASP-1731
2006-003288-29 ( EudraCT Number )
Study First Received: May 3, 2007
Results First Received: November 30, 2009
Last Updated: January 5, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin degludec, insulin aspart drug combination
Glimepiride
Insulin
Metformin
Insulin Glargine
Insulin, Isophane
Biphasic Insulins
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on June 27, 2017