Phase 4
Completed N=582
Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin
Source: ClinicalTrials.gov NCT01519674 ↗Enrolled (actual)
582
Serious AEs
2.8%
Results posted
Nov 2014
Primary outcomePrimary: Change From Baseline in HbA1c (Glycosylated Haemoglobin) — -1.27; -1.51; -1.15 percentage of glycosylated haemoglobin — p=0.011
Summary
This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30 (biphasic insulin aspart 30) by adding or substituting BIAsp 30 to sitagliptin in various regimens for type 2 patients inadequately controlled on sitagliptin and metformin (with or without other oral anti-diabetic drugs (OADs)).
The trial is conducted as a phase 4 trial in the majority of the participating countries. However, in some countries the trial is conducted as phase 3b.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (Glycosylated Haemoglobin) |
-1.27; -1.51; -1.15 | 0.011 sig |
| SECONDARY Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%) |
49.7; 59.8; 46.5 | 0.022 sig |
| SECONDARY Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%) |
30.6; 40.7; 25.1 | 0.020 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
-1.90; -2.03; -1.96 | 0.520 |
| SECONDARY Prandial Plasma Glucose (PPG) Increments at Breakfast |
2.01; 1.73; 2.89 | 0.291 |
| SECONDARY Prandial Plasma Glucose (PPG) Increments at Lunch. |
3.05; 2.19; 2.52 | 0.005 sig |
| SECONDARY Prandial Plasma Glucose (PPG) Increments at Dinner. |
0.89; 1.01; 0.17 | 0.674 |
| SECONDARY Prandial Plasma Glucose (PPG) Overall Mean Increment. |
1.97; 1.66; 1.88 | 0.080 |
| SECONDARY Adverse Events (AEs) |
262.2; 209.9; 281.2; 8.4; 5.8; 10.5 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes. |
515; 440; 249; 68; 54; 63 | — |
| SECONDARY Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes. |
6.22; 5.93; 6.20 | 0.800 |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with type 2 diabetes for a minimum of 6 months prior to screening (Visit 1)
- Stable treatment with a total daily dose of at least 1000 mg of metformin (with or without additional oral anti-diabetic drugs (OADs) treatment). The metformin dose must have been unchanged for at least 3 months prior to screening (Visit 1)
- Stable treatment with a total daily dose of at least 100 mg sitagliptin. The sitagliptin dose must have been unchanged for at least 3 months prior to screening (Visit 1)
- Subject is insulin-naïve (never previously treated with insulin). (However, short term insulin use due to intermittent illness of up to 14 days or insulin treatment for gestational diabetes is allowed)
- HbA1c (glycosylated haemoglobin) between 7.0 to 10.0 % (53-86 mmol/mol) (both inclusive) by central laboratory analysis demonstrating inadequate control on sitagliptin and metformin (with or without other OADs)
- Body Mass Index (BMI) below or equal to 40.0 kg/m^2
- Able and willing to eat at least 2 meals (breakfast and dinner) every day during the trial
Exclusion Criteria
- Treatment with thiazolidinedione (TZD) or glucagon-like-peptide-1 (GLP-1) receptor agonist within the last 3 months prior to screening (Visit 1)
- Cardiac disease within the last 6 months prior to screening (Visit 1), defined as: decompensated heart failure New York Heart Association (NYHA) class III or IV; unstable angina pectoris; or myocardial infarction
- Severe hypertension, systolic blood pressure equal to or above 180 mm Hg or diastolic blood pressure equal to or above 100 mm Hg, after 5 minutes rest in the sitting position using mean value of 3 measurements at screening (Visit 1)
- Anticipated change of dose of any systemic treatment with products, which in the trial physician's opinion could interfere with glucose metabolism (e.g., systemic corticosteroids)
- Clinically significant diseases (except for conditions associated with type 2 diabetes) which, in the trial physician's opinion may confound the results of the trial or pose additional risk in administering trial product(s)
- Impaired hepatic function as indicated by aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) above 2.5 times the upper normal range, according to central laboratory reference ranges
- Impaired renal function as indicated by serum creatinine levels equal to or above 133 micromol/L (1.5 mg/dL) for males and equal to or above 124 micromol/L (1.4 mg/dL) for females or estimated creatinine clearance below 60 mL/min, based on the Cockroft & Gault formula and according to local practise for metformin use
Data sourced from ClinicalTrials.gov (NCT01519674). 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.