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 |
Mild diabetes arising in pregnancy |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000138 |
E.1.2 | Term | Abnormal glucose tolerance in pregnancy |
E.1.2 | System Organ Class | 100000004861 |
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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 |
Assess recruitment rates and acceptability of the proposed trial with particular attention to different ethnic groups |
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E.2.2 | Secondary objectives of the trial |
1) Assess compliance in the different intervention arms of the trial
2) Determine the number of women in the intensive arm of the trial who require insulin treatment in addition to metformin based on home blood glucose monitoring
3) Ensure appropriateness and validity of the collection methods of standard clinical outcomes
4) Assess the perceived implications of a diagnosis of GDM in this group using a questionnaire
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Women with risk factors for GDM (NICE 2008) will be offered an oral glucose tolerance test (OGTT) at 26 weeks gestation as part of their routine antenatal care. Women will be provided with written information regarding the study at the time of the OGTT. Women with mild fasting hyperglycaemia (5.1-5.4 mmol/L, 2 hour <8.5 mmol/L) will be invited to take part in the study by telephone and invited to attend an appointment (telephone interpretation services will be used where English is not the first language).
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E.4 | Principal exclusion criteria |
Multiple pregnancy
Previous stillbirth
Previous shoulder dystocia
Age under 16
Incapacity to consent |
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E.5 End points |
E.5.1 | Primary end point(s) |
Recruitment rate and acceptability of intervention. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Three months after recruitment. |
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E.5.2 | Secondary end point(s) |
1) Assess compliance in the different intervention arms of the trial
2) Determine the number of women in the intensive arm of the trial who require insulin treatment in addition to
metformin based on home blood glucose monitoring
3) Ensure appropriateness and validity of the collection methods of standard clinical outcomes
4) Assess the perceived implications of a diagnosis of GDM in this group using a questionnaire |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Within six months of recruitment of final woman. |
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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 | No |
E.6.5 | Efficacy | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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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12 months allowed for data collection and analysis following delivery of the last participant. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |