Type 2 diabetes MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Victoza
Product Name: Victoza
Pharmaceutical Form: Solution for injection in pre-filled pen
Pharmaceutical form of the placebo: Solution for injection in pre-filled pen
Route of administr
Sponsors
Turku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 100 women, who have had gestational diabetes with treatment with metformin and/or insulin (fasting P-glucose >5.5 mmol/l at home measurements, in >50% of the measurements per week) and who have stopped lactation and are not pregnant and have signed informed consent are enrolled between 6 to 12 months after delivery. In that consent the women certify that they will use IU-device or oral contraceptive in order to avoid becoming pregnant during the next year. They have BMI>30 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Diagnosed with diabetes mellitus type 1 or type 2, drugs with potential effect on P-glucose such as use of betablockers, antidepressives, statins and starting any anti-hyperglycemic therapies f.ex insulin, metformin, (as sign of primary end-point reached), new pregnancy. Severe hepatic insufficiency, end stage renal disease, acute pancreatitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: from year 1 to 5;Main Objective: to investigate if 12 months’ liraglutide treatment (1.8 mg, strength 6 mg/ml) once daily could decrease the risk of T2D in obese women who have had gestational diabetes needing treatment with metformin and/or insulin.;Secondary Objective: prevention glugoce intolerance and/or increase fasting glugose levels;Primary end point(s): Development of T2DM (fasting P-glucose >7 mmol/l and/ or 2 h >11 mmol/l in OGTT 75g, and/or HbA1c= 6.5 %) from year 1 to 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2 h PPG measured by 75g OGTT and fasting P-glucose, weight loss, BP, plasma lipids, Metabolic syndrome according to IDF criteria (Central obesity defined as waist circumference = 80cm plus any 2 of the following 4 factors: raised TG level: = 1.7 mmol/L or specific treatment for this; reduced HDL cholesterol: < 1.29 mmol/L or specific treatment for this; raised blood pressure: systolic BP = 130 or diastolic BP = 85 mm Hg, or treatment of previously diagnosed hypertension; raised fasting plasma glucose (FPG) = 5.6 mmol/L or previously diagnosed type 2 diabetes) , development of gestational diabetes;Timepoint(s) of evaluation of this end point: from 1 to 5 year | — |
Countries
Finland
Outcome results
None listed