Clinical trial NCT00807092: Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes
Official title: Comparison of the Efficacy on Glycaemic Control and Safety Profile of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 Both in Combination With Metformin in Insulin-naïve Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Drugs (OADs) Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive subjects with type 2 diabetes when failing on oral antidiabetic drug (OAD) therapy.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes diagnosed for at least 6 months
* Insulin-naive (less than or equal to 1 week of daily use of insulin therapy)
* Treatment with metformin as monotherapy or in combination therapy with other OAD(s) for at least 3 months prior to this trial
* Currently on metformin greater than or equal to 1000 mg/day for at least 2 weeks
* Currently at least one of other OAD(s) reaching at least one-half of the recommended maximum dose for at least 2 weeks
* Glycosylated haemoglobin (HbA1c) between 7.5-11.0%
* Body Mass Index (BMI) between 18.5 - 35.0 kg/m\^2
* Be able and willing to perform continuous glucose monitoring system (CGMS ) and self-monitored blood glucose (SMBG)

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Any contraindication of metformin
* Receipt of investigational drug within the last 3 months prior to this trial
* Any history of chronic insulin therapy (more than 1 week of daily use)
* Systemically treated with thiazolidinediones (TZDs) for more than one month within 6 months prior to this trial
* Pregnancy, nursing mother, or unwillingness to use adequate contraception

Primary outcomes:
measure: Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals
timeFrame: Week 0, week 6
Secondary outcomes:
measure: Change in Mean IAUC for Postprandial Glucose (0-4 Hours) After Each Meal (Breakfast, Lunch, Dinner) Assessed by CGMS
timeFrame: Week 0, Week 6
measure: Mean FBG (Fasting Blood Glucose) Assessed by CGMS
timeFrame: Week 6
measure: Change in Mean FBG Assessed by CGMS
timeFrame: Week 0, week 6
measure: Change in FPG (Fasting Plasma Glucose)
timeFrame: Week 0, Week 6
measure: Change in 8-point SMBG (Self-monitored Blood Glucose) Profiles
timeFrame: Week 0, Week 6
measure: Change in Prandial Blood Glucose Increment
timeFrame: Week 0, Week 6
measure: Change in MAGE (Mean Amplitude of Glycaemic Excursions) Assessed by CGMS
timeFrame: Week 0, Week 6
measure: Change in GA (Glycated Albumin)
timeFrame: Week -2, week 6
measure: Change in Glycosylated Haemoglobin (HbA1c)
timeFrame: Week -2, week 6
measure: Duration of Hypoglycaemic Events Based on CGMS
timeFrame: 72-hour monitoring period at Week 0 and Week 6
measure: Hypoglycaemia Based on Self-reported Episodes
timeFrame: Weeks 0-6
Other outcomes:
Locations:
city: Beijing
country: China
state: Beijing
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: