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] - 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 |
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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 |
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 |
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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.
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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. |
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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% |
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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 POINT(S):
E.5.1 Primary End Point (repeat as necessary)26
English The change in HbA1C from baseline at Week 24
E.5.1.1 Timepoint(s) of evaluation of this end point
English Baseline to 24 weeks
E.5.2 Secondary End Point (repeat as necessary)
English |
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E.5 End points |
E.5.1 | Primary end point(s) |
The change in HbA1C from baseline at Week 24 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | 6 |
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 |
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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
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
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 |