E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Impaired Glucose tolerance and Impaired fasting Glycaemia (Together known as Prediabetes) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000146 |
E.1.2 | Term | Abnormal glucose tolerance test (excl DM) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10056997 |
E.1.2 | Term | Impaired fasting glucose |
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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 primary outcome will be the change in HOMA-IR in the intervention and control arms after 12 months of trial medication.
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E.2.2 | Secondary objectives of the trial |
Secondary outcomes will include changes in weight, waist and hip circumference, proportion with Metabolic Syndrome (Met S), levels of inflammatory biomarkers, lipid profile, pulse wave velocity ( PWV), Liver function tests(LFT) especially Alanine amino transferase (ALT) and Gamma Glutamyl transferase (GGT).
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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 |
Sub study invoolves measuring Carotid Femoral pulse wave velocity in these subjects at basline and at 12 months. |
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E.3 | Principal inclusion criteria |
1) Consenting Male or female participants aged 25 to 75 years of Age 2) BMI > 27.5 kg/m2 in South Asians, BMI >30 in White Europeans. 3) Confirmed with Impaired Glucose tolerance and/or Impaired fasting glucose by OGTT using WHO criteria. |
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E.4 | Principal exclusion criteria |
1) Pregnant or breast feeding women, 2) Absence of medically approved contraceptive usage in women of child bearing age 3) History of eating disorders 4) Known severe renal or hepatic impairment 5) People with cardiac failure 6) Severe psychiatric disorders defined as depression requiring hospitalization in the past or suicidal attempt in the past 7) Housebound 8) Terminally ill or already diagnosed with diabetes mellitus 9) People currently on or in previous 3 months on anti-obesity medication. 10) People unable to offer informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end point is change in Insulin Resistance as determined by Homeostatic model assesment of Insulin Resistance. (HOMA-IR) This is a validated method of determining Insulin resistance using Fasting Plasma Glucose and Insulin levels applied to a standerdised equation. |
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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 | Yes |
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 | Information not present in EudraCT |
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 | 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.8.3 |
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 | 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
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End of the trial is defined as the subjects having taken trial medications for 12 months. |
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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 | 1 |
E.8.9.1 | In the Member State concerned days | 0 |