Phase 4
Completed N=245
Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone
Source: ClinicalTrials.gov NCT01215435 ↗Enrolled (actual)
245
Serious AEs
2.9%
Results posted
Nov 2013
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11 — -1.04; -0.90 percentage of glycosylated haemoglobin — p=<0.001
Summary
This trial is conducted in Asia. The aim of this trial is to compare the glycaemic control when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic drugs) alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11 |
-1.04; -0.90 | <0.001 sig |
| SECONDARY Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36 |
-61.57; -58.43 | 0.6215 |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes |
1181; 953 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1
- HbA1c at least 7.0 % - maximum 11 % at screening
- Subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)
- An antidiabetic regimen that has been stable for at least 3 months prior to screening
- An antidiabetic regimen that includes a minimum of 2 OADs
- OADs dosed at least 50% of the maximum recommended dose
Exclusion Criteria
- Known or suspected hypersensitivity to trial product(s) or related products
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
- The receipt of any investigational medicinal product within one month prior to this trial
- Suffer from a life threatening disease (cancer)
- Cardiac disease: class III or IV congestive heart failure (CHF), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening
- Hepatic insufficiency (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 2 times the central laboratory's upper reference limit)
- Renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females
- Recurrent hypoglycaemia or hypoglycaemic unawareness
- Anemia (haemoglobin below 10 mg/dl)
Data sourced from ClinicalTrials.gov (NCT01215435). 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.