Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

Overview[ - collapse ][ - ]

Purpose This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.
ConditionDiabetes
Diabetes Mellitus, Type 2
InterventionDrug: biphasic insulin aspart 30
Drug: metformin
PhasePhase 4
SponsorNovo Nordisk A/S
Responsible PartyNovo Nordisk A/S
ClinicalTrials.gov IdentifierNCT00669864
First ReceivedApril 29, 2008
Last UpdatedJune 5, 2012
Last verifiedJune 2012

Tracking Information[ + expand ][ + ]

First Received DateApril 29, 2008
Last Updated DateJune 5, 2012
Start DateNovember 2007
Estimated Primary Completion DateApril 2009
Current Primary Outcome MeasuresChange in HbA1c (Glycosylated Haemoglobin A1c) [Time Frame: week 0, week 16] [Designated as safety issue: No]Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)
Current Secondary Outcome Measures
  • Change in 8-point Plasma Glucose Profile [Time Frame: week 0, week 16] [Designated as safety issue: No]Summary of change in 8-point plasma glucose profile by week and time. The 8 time points measured were: Before each meal (breakfast, lunch and dinner), at 2 hours after each meal (breakfast, lunch and dinner), at bedtime, and at 3 AM, measured over 16 weeks of treatment
  • Percentage of Subjects Achieving HbA1c Less Than 7.0% [Time Frame: week 16] [Designated as safety issue: No]Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below 7.0% after 16 weeks of treatment
  • Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% [Time Frame: week 16] [Designated as safety issue: No]Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below or equal to 6.5% after 16 weeks of treatment
  • Hypoglycaemic Episodes [Time Frame: weeks 0-16] [Designated as safety issue: Yes]Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment). 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.
  • Hypoglycaemic Episodes, Diurnal/Nocturnal [Time Frame: weeks 0-16] [Designated as safety issue: Yes]Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment) during the day (diurnal) and the night (nocturnal).

Descriptive Information[ + expand ][ + ]

Brief TitleEffect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin
Official TitleEffect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin
Brief Summary
This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose
control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese
subjects with type 2 diabetes inadequately controlled with once or twice daily basal
insulin.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Diabetes
  • Diabetes Mellitus, Type 2
InterventionDrug: biphasic insulin aspart 30
Subcutaneous (under the skin) injection, twice daily
Other Names:
NovoMix® 30Drug: metformin
Tablets, 1000 - 2000 mg daily
Study Arm (s)Experimental: BIAsp 30-30
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment293
Estimated Completion DateApril 2009
Estimated Primary Completion DateApril 2009
Eligibility Criteria
Inclusion Criteria:

- Type 2 diabetes

- Currently treated with basal insulin once or twice daily with or without oral
anti-diabetic drugs (OADs) for at least 3 months

- HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both
inclusive)

- BMI (Body Mass Index) maximum 40 kg/m2

Exclusion Criteria:

- Metformin contraindications according to local practice

- Systemically treated with TZDs (thiazolidinediones) for more than one month within 6
months prior to this trial
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesChina

Administrative Information[ + expand ][ + ]

NCT Number NCT00669864
Other Study ID NumbersBIASP-1960
Has Data Monitoring CommitteeNo
Information Provided ByNovo Nordisk A/S
Study SponsorNovo Nordisk A/S
CollaboratorsNot Provided
Investigators Study Director: Ruifang LIANG Novo Nordisk A/SStudy Director: HONGFEI XU Novo Nordisk A/S
Verification DateJune 2012

Locations[ + expand ][ + ]

China, Beijing
Beijing, Beijing, China, 100034