E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067584 |
E.1.2 | Term | Type 1 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 |
The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes |
|
E.2.2 | Secondary objectives of the trial |
- % change in total daily insulin dose and body weight.
- Change in:
- mean value of 24-hr glucose readings obtained from CGM
- mean amplitude of glucose excursion of CGM 24-hr glucose readings
- % CGM 24-hr glucose readings between > or = 70 and < or = 180 mg/dL
- Proportion of subjects with A1C reduction > or = 0.5% and no severe hypoglycemia events.
|
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacogenetics Blood Sample Amendment Number 01- Site Specific,
dated 10-Sep-2014
The objective of this Amendment is to permit the collection and storage
of blood samples for use in future exploratory pharmacogenetic
research. |
|
E.3 | Principal inclusion criteria |
1- Diagnosis of T1DM: Central laboratory test of C-peptide < 0.7 ng/ml
2- Insulin use for at least 12 months prior to screening per patient
reported or medical records and
a- Method of insulin administration (MDI or CSII) must have been
unchanged for at least 3 months prior to the screening visit. Subjects
must be on a total insulin dose of >or= 0.3 U/kg/day for at least 3
months prior to the screening visit.
b- If on MDI insulin administration, subject must be on >or= 3 injections
per day.
3- A1C eligibility criteria include: Screening Visit: Central laboratory A1C
>or= 7.7% and <or= 11.0% |
|
E.4 | Principal exclusion criteria |
- History of T2DM or maturity onset diabetes of young (MODY),
pancreatic surgery, or chronic pancreatitis or other pancreatic disorders
that could result in decreased β-cell capacity
- Previous use of dapagliflozin and/or any other SGLT-2 inhibitors |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The change in HbA1C from baseline at Week 24 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
%change in total daily insulin dose and body weight at week 24
Change in:
- mean value of 24-hr glucose readings obtained from CGM
- mean amplitude of glucose excursion of CGM 24-hr glucose readings
- % CGM 24-hr glucose readings between >or=70 and <or=180 mg/dL
Proportion of subjects with A1C reduction >0.5% and no severe
hypoglycemia events. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 45 |
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 |
Australia |
Austria |
Belgium |
Canada |
Denmark |
Finland |
France |
Germany |
Hungary |
Israel |
Italy |
Mexico |
Romania |
Spain |
Sweden |
United Kingdom |
United States |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |