Latent Autoimmune diabetes of the adult (LADA) is a form of diabetes where the onset of the diabetes starts after 30 years of age, there is presence of beta-cell directed antibodies (mostly anti-GAD) and no clinical need for insulin during the first 3 months after the diagnosis of diabetes. MedDRA version: 17.1 Level: PT Classification code 10066389 Term: Latent autoimmune diabetes in adults System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Metformin
Product Name: Metformin
Pharmaceutical Form: Tablet
Trade Name: Repaglinid
Product Name: Repaglinid
Pharmaceutical Form: Tablet
Trade Name: Sitagliptin
Product Name: sitaglipti
Sponsors
Institute of Cancer research and molecular medicine.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women have to be diagnosed with diabetes within 3 years before entering the study. Operational criteria for a diagnosis of LADA will be anti-GAD positivity, fasting C-peptide > 0.3 ng/ml and no need for insulin treatment by clinical judgement for at least 3 months following the diagnosis of diabetes. Age 30-75 years. Criteria related to blood glucose control ; HbA1c levels > 10 % above the upper limit of normal at screening and >5% above the upper limit of normal at randomization. Females of reproductive age can be included if they have a negative pregnancy test at study inclusion and if anticontraception is used during the study. Pregnancy tests will be taken every third month. 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Ongoing insulin treatment Renal insufficiency (plasma creatinine > 150 mol/L) Severe retinopathy (proliferativ or pre-proliferative) oral antidiabetic treatment except metformin Severe cardiac disease (NYHA III-IV) Cronic severe illness judged by the investigator. Females of reproductive age who wish to become pregnant during the study lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether insulin added to metformin compared with peroral antidiabetic treatment added to metformin better preserve beta cell function in patients with LADA? ;Secondary Objective: To evaluate whether insulin added to metformin compared with peroral antidiabetic treatment added to metformin results in better metabolic control in patients with LADA? To evaluate whether insulin added to metformin compared with peroral antidiabetic treatment added to metformin can improve Quality of Life in patients with LADA? ;Primary end point(s): The main endpoint of the study is the outcomes of C-peptide glucagon tests. ;Timepoint(s) of evaluation of this end point: The main endpoint of the study is the outcomes of C-peptide glucagon tests at 0, 3, 9, 21, 33, 45 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Fasting C- peptide ratio of fasting plasma glucose versus fasting C-peptide, fasting proinsulin, creatinine, insulin and metabolic control as measured by HbA1c , glucose monitoring at home and ev. change of the anti - GAD titer. SF36 Questionnaire , DTSQ and WBQ12;Timepoint(s) of evaluation of this end point: Fasting C- peptide ratio of fasting plasma glucose versus fasting C-peptide, fasting proinsulin, creatinine, insulin and metabolic control as measured by HbA1c , glucose monitoring at home and ev. change of the anti - GAD titer at 0, 3, 9, 21, 33, 45 month Questionnaire SF36, DTSQ and WBQ12 at 0, 3, 15, 33, 45 | — |
Countries
Finland, Sweden
Contacts
Public ContactValdemar Grill
Institute of Cancer research and molecular medicine.
Outcome results
None listed