Pre-diabetes MedDRA version: 18.0 Level: LLT Classification code 10065542 Term: Prediabetes System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Metformin "Aurobindo"
Product Name: Metformin "Aurobindo"
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: metforminhydrochlorid
Sponsors
Steno Diabetes Center A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • HbA1c 6.0-6.4% (42-47 mmol/mol) • Age 35-70 years • BMI = 25 kg/m2 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: • Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, gastrointestinal or psychiatric disease; diabetes or other endocrine disease; immunosuppression • Treatment with hormones which affect glucose metabolism • Treatment with loop diuretics or thiazolidinediones • Treatment with beta blockers or peroral steroids • Bariatric surgery within the past 2 years • Impaired renal function defined as an estimated GFR<60 ml/min/1.73m2 • Neurogenic bladderdisorders •Alcohol/drug abuse or in treatment with disulfiram (Antabus) at time of inclusion • Pegnant or lactating women •Fertile women not using birth control agents including oral contraceptives, gestagen injection, subdermal implantation hormonal vaginal ring, transdermal application, or intra-uterine devices •Allergic to one or more of the medications used in the study •Treatment with peroral steroids •Concomitant participation in other intervention study •Unable to understand the informed consent and the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective is to compare the short-term effectiveness of three glucose-lowering interventions (physical activity, metformin, and dapagliflozin) on glucose variability, body composition, and cardiometabolic risk factors in overweight or obese individuals with pre-diabetes (HbA1c 6.0-6.4%). ; Secondary Objective: Secondary objectives are to identify subgroups with different phenotypes who do not respond or respond better than others to lifestyle and pharmacological interventions. Also, to determine how daily exercise bouts and time spent in sedentary and in moderate-to-vigorous physical activity intensities are related to measures of glucose variability, insulin sensitivity and beta cell function. ;Primary end point(s): Reduction in mean amplitude of glycaemic excursions (MAGE) from baseline to end-of treatment (measured over 48 hours in the middle of the 6-day measurement periods). ;Timepoint(s) of evaluation of this end point: After 13 weeks of intervention and 26 weeks after baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: After 13 weeks of intervention and 26 weeks after baseline; Secondary end point(s): Changes from baseline to end-of-treatment and to 3-months follow-up: •Reduction in HbA1c •Reduction in intra-day glycaemic variability (CONGA (28)); •Reduction in daily time spent >6.1 mmol/L, >7.0 mmol/L, >7.8 mmol/L, and >11.1 mmol/L; •Reduction in fasting and 2-hour glucose concentrations during OGTT; •Improvement in insulin secretion, insulin sensitivity and disposition index; •Reduction of MAGE and CONGA in subgroups of individuals with different baseline characteristics; •Reduction in body weight and change in body fat distribution; •Changes in basal and physical activity energy expenditure and substrate oxidation; •Changes in time spent sedentary and in moderate-to-vigorous physical activity intensity; •Reduction in blood pressure and lipids; • Changes in biomarkers of metabolic functions (e.g. metabolites, phospholipids, amino acids, inflammatory markers); •Number of adverse events and side effects; •Changes in self-rated health and quality of life; •Adherence to the different interventions. | — |
Countries
Denmark
Contacts
Public ContactSponsor
Steno Diabetes Center A/S
Outcome results
None listed