E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063624 |
E.1.2 | Term | Type II diabetes mellitus inadequate control |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To confirm efficacy of subject-driven titration of biphasic insulin aspart (BIAsp) 30 twice daily in
terms of glycaemic control assessed by change in glucosylated haemoglobin (HbA1c). This is done
by showing that subject-driven titration of BIAsp 30 is non-inferior to investigator-driven titration
of BIAsp 30 with respect to glycaemic control, as measured by HbA1c after 20 weeks of treatment
in subjects with type 2 diabetes inadequately controlled on basal insulin analogues. |
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E.2.2 | Secondary objectives of the trial |
- To assess and compare efficacy in terms of:
- Fasting plasma glucose (FPG) values
- 7-point Self Measured Plasma Glucose (SMPG) profile
- To assess and compare safety and tolerability in terms of:
- Hypoglycaemic episodes
- Adverse events (AEs)
- Clinical and laboratory assessments
- Change in body weight
- To assess time to plasma glucose (PG) target in terms of:
2-point Self Measured Plasma Glucose (SMPG) profile
- To evaluate insulin dose
- To assess diabetes treatment satisfaction
- To assess healthcare resource utilization |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female, age ≥18
- Diagnosed with type 2 diabetes for a minimum of 12 months prior to Visit 1
- Currently treated with a basal insulin analogue for at least 3 months prior to Visit 1
- Stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg
metformin or maximum tolerated dose (minimum 1000 mg) ± additional OAD treatment. The
metformin treatment must have been stable for at least 2 months prior to Visit 1
- HbA1c ≥ 7.0% and ≤10.0%. (One re-test within one week of screening visit is allowed. The last
sample will be conclusive.)
- Body Mass Index (BMI) ≤ 40.0 kg/m2
- Able and willing to eat at least 2 main meals each day during the trial
- Able and willing to adhere to the protocol including compliance with performance of self
measured plasma glucose (SMPG), injection regimen and titrating themselves according to the
protocol
- Experience in performing self measured plasma glucose (SMPG) |
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E.4 | Principal exclusion criteria |
- Treatment with any thiazolidinedione (TZD) and Glucagon-like peptide-1 (GLP-1) receptor
agonists or pramlintide within the last 3 months prior to Visit 1
- Impaired hepatic function defined as alanine aminotransferase (ALAT)≥ 2.5 times upper
referenced limit. (One re-test within one week of screening visit is allowed. The last sample will
be conclusive.)
- Impaired kidney function with serum creatinine ≥ 133 μmol/L (1.5 mg/dL) for males and ≥ 124
μmol/L (1.4 mg/dL) for females. (One re-test within one week of screening visit is allowed. The
last sample will be conclusive.)
- Cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic
blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg)
- Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human
preparations) or bolus insulin. Previous use of pre-mixed or bolus insulin products is allowed only in case of hospitalisation or a severe condition requiring intermittent use of premixed or bolus insulin products for less than 14 consecutive days, but not during the last 3 months prior to screening visit (Visit 1) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in HbA1c from baseline to week 20/end of trial |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
from baseline to week 20/end of trial |
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E.5.2 | Secondary end point(s) |
1- Change in fasting plasma glucose (FPG) (central laboratory values) from baseline to week
20/end of trial
2- Number of hypoglycaemic episodes during the trial
3- Patient Reported Outcomes evaluated at baseline, at week 4 and at week 20/end of trial with:
- Treatment-Related Impact Measures for Diabetes (TRIM-D) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1- from baseline to week
20/end of trial
- during the trial
- at baseline, at week 4 and at week 20/end of trial with:
- Treatment-Related Impact Measures for Diabetes (TRIM-D) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
China |
India |
Poland |
Spain |
Turkey |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 24 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 24 |