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 |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036556 |
E.1.2 | Term | Pregnancy |
E.1.2 | System Organ Class | 10036585 - Pregnancy, puerperium and perinatal conditions |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029883 |
E.1.2 | Term | Obesity |
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 aim of this study is to determine if metformin, administered to obese women during pregnancy, reduces the future life risk of obesity and metabolic syndrome in their babies. |
|
E.2.2 | Secondary objectives of the trial |
We will use metformin administration as a tool to explore the mechanism by which obesity causes adverse pregnancy outcomes, with a particular focus on insulin resistance (IR). |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Caucasian obese (BMI ≥ 30 kg/m2) pregnant women between ≥ 12-0 and ≤ 16+0 weeks gestation Women age ≥16 years Signed informed consent form
|
|
E.4 | Principal exclusion criteria |
• Non Caucasian women • Women with a BMI ≤ 29 kg/m2 • Gestation > than 16 weeks • Women with pre-existing diabetes • Women with gestational diabetes in a previous pregnancy • Women with systemic disease requiring medication. • Gestational diabetes in index pregnancy (diagnosed with 75g OGTT tested (WHO criteria prior to randomisation) • A known pregnancy complications in this or a previous pregnancy likely to impact of birthweight or gestation at delivery • A known hypersensitivity to metformin hydrochloride or to any of the excipient. • Known abnormalities of the liver (tested prior to randomisation) • Renal failure or renal dysfunction • Acute conditions with the potential to alter renal function such as: o dehydration, o severe infection, o shock, o intravascular administration of iodinated contrast agents o Acute or chronic diseases which may cause tissue hypoxia such as: o cardiac or respiratory failure, o recent myocardial infarction, o shock o hepatic insufficiency, acute alcohol intoxication, alcoholism, • Lactation
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. What is the efficacy of metformin (up to 2500mg daily), given to obese pregnant women from 12 - 16 weeks gestation until delivery in reducing birthweight centile of the baby? 2. What is the pattern of association between insulin resistance and adverse pregnancy outcome in obese pregnant women?
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | 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 | Yes |
E.8.2.3 | Other | No |
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 | 3 |
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 | 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
|
last participant, last visit |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |