E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with type 2 diabetes mellitus |
|
E.1.1.1 | Medical condition in easily understood language |
patients with type 2 diabetes |
|
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 | PT |
E.1.2 | Classification code | 10053247 |
E.1.2 | Term | Insulin-requiring type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
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 |
Our primary objective is to demonstrate that the addition of liraglutide 1.8 mg sc q.d. to patients on short-term insulin therapy (≤ 12 months) can reverse the (excessive) weight gain without deteriorating glycaemic control. |
|
E.2.2 | Secondary objectives of the trial |
Our secondary objectives are to determine the effect of liraglutide on glycaemic control, number and severity of hypoglycaemic events, (decrease in) insulin dose, number of patients discontinuing insulin therapy, physical activity, cardiovascular risk markers and quality of life. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with type 2 diabetes mellitus on short-term insulin therapy
(≤ 12 months); all types of insulin allowed
- Insulin-associated weight gain ≥ 3.0 kg from the start of insulin therapy
- Age 18-75 years
- BMI ≥ 25 kg/m2
- Stable glycaemic control mirrored by HbA1c ≥ 6.5 and ≤ 8.5 %
|
|
E.4 | Principal exclusion criteria |
- Inability to provide informed consent
- Type 1 diabetes mellitus, MODY diabetes, or LADA diabetes
- Presence of any medical condition that might interfere with the current
study protocol.
- Inflammatory bowel disease (e.g. M. Crohn, ulcerative colitis)
- Recurrent hypoglycaemic events
- Diabetic gastroparesis
- Heart failure (LVEF ≤ 30%)
- Use of TZDs (glitazones), DDP-IV (dipeptidylpeptidase-inhibitor)
- Use of medication associated with impaired glucose metabolism including
corticosteroids
- Pregnancy or breast-feeding (contraception of at least 3 months before
inclusion is required for fertile women)
- Pre-existing thyroid disease
- Liver disease (aspartate aminotransferase or alanine aminotransferase
level of more than three times the upper limit of normal range)
- Renal disease (creatinine > 130 µmol/l or MDRD-GFR <30 ml/min/1.73m2)
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in body weight after 6 months of Liraglutide treatment |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Every 4 weeks outpatient contact, every 8 weeks A1c measurements and at the start and end Senswear body media monitoring |
|
E.5.2 | Secondary end point(s) |
Insulin dose, hypoglycaemia and glucoses. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Every 4 weeks evaluation of insulin dose en glucoses. |
|
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 | Yes |
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 | No |
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 |
|
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 | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
Study ends after 6 months of liraglutide treatment |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |