Phase 4
Completed N=145
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
Source: ClinicalTrials.gov NCT00807092 ↗Enrolled (actual)
145
Serious AEs
2.8%
Results posted
Apr 2011
Primary outcomePrimary: Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals — -1.99; -1.977 mmol/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals |
-1.99; -1.977 | — |
| SECONDARY Change in Mean IAUC for Postprandial Glucose (0-4 Hours) After Each Meal (Breakfast, Lunch, Dinner) Assessed by CGMS |
-3.094; -4.272; 1.651; 1.969; -4.775; -4.026 | 0.2412 |
| SECONDARY Mean FBG (Fasting Blood Glucose) Assessed by CGMS |
6.861; 6.414 | 0.0891 |
| SECONDARY Change in Mean FBG Assessed by CGMS |
-2.114; -2.561 | — |
| SECONDARY Change in FPG (Fasting Plasma Glucose) |
-2.961; -3.456 | 0.0472 sig |
| SECONDARY Change in 8-point SMBG (Self-monitored Blood Glucose) Profiles |
-2.27; -2.38; -3.99; -5.22; -3.46; -3.73 | 0.676 |
| SECONDARY Change in Prandial Blood Glucose Increment |
-1.82; -2.82; 1.32; 1.27; -1.91; -1.85 | 0.062 |
| SECONDARY Change in MAGE (Mean Amplitude of Glycaemic Excursions) Assessed by CGMS |
-0.499; -0.686 | 0.6149 |
| SECONDARY Change in GA (Glycated Albumin) |
-6.147; -6.474 | 0.5706 |
| SECONDARY Change in Glycosylated Haemoglobin (HbA1c) |
-1.647; -1.667 | 0.8598 |
| SECONDARY Duration of Hypoglycaemic Events Based on CGMS |
0.304; 0.358; 0.048; 0.06 | 0.671 |
| SECONDARY Hypoglycaemia Based on Self-reported Episodes |
63; 55; 3; 3; 9; 10 | — |
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
Data sourced from ClinicalTrials.gov (NCT00807092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.