The Rimonabant in treatment of Prediabetes Study: a randomised clinical trial of Rimonabant in the treatment of patients with Prediabetes - Rimonabant Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000940-28-GB

Enrollment

300

Registered

2007-06-26

Start date

2007-11-28

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired Glucose tolerance and Impaired fasting Glycaemia (Together known as Prediabetes) MedDRA version: 9.1 Level: LLT Classification code 10000146 Term: Abnormal glucose tolerance test (excl DM) MedDRA version: 9.1 Level: LLT Classification code 10056997 Term: Impaired fasting glucose

Interventions

Trade Name: Accomplia Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary outcome will be the change in HOMA-IR in the intervention and control arms after 12 months of trial medication. ; Secondary Objective: 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). ;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.	—

Measure

Time frame

Main Objective: The primary outcome will be the change in HOMA-IR in the intervention and control arms after 12 months of trial medication. ; Secondary Objective: 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). ;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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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026