Linagliptin and empagliflozin in children and adolescents (DINAMO)
Research type
Research Study
Full title
A double-blind, randomised, placebo-controlled, parallel group trial to evaluate the efficacy and safety of empagliflozin and linagliptin over 26 weeks, with a double-blind active treatment safety extension period up to 52 weeks, in children and adolescents with type 2 diabetes mellitus.
IRAS ID
237302
Contact name
Christina Wei
Contact email
Eudract number
2016-000669-21
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
3 years, 7 months, 3 days
Research summary
This study is a double-blind, randomised, placebo-controlled, parallel group trial to evaluate the efficacy and safety of empagliflozin and linagliptin over 26 weeks, with a double-blind active treatment safety extension period up to 52 weeks, in children and adolescents with type 2 diabetes mellitus. Each child will have an equal chance of being placed in any of the following groups; Empagliflozin 10 mg and then new randomisation after 14 weeks to either empagliflozin 10 mg or empagliflozin 25 mg depending on his/her glycaemic level (i.e., HbA1c value) after 12 weeks of treatment; Linagliptin 5 mg (treatment remains unchanged for the remainder of the trial) Placebo and then new randomisation after 26 weeks to either empagliflozin 10 mg or empagliflozin 25 mg or linagliptin 5 mg. . Each participant is expected to take part in the study for approximately one year and 2 months (58 weeks) and they will require approximately 11 visits to the trial clinic. Participants will be expected to have blood tests, physical examinations and an ECG and be expected to record daily their blood sugar and ketone measurements in a diary.
Summary of Results
DIabetes study of liNAgliptin and eMpagliflozin in children and adOlescents (DINAMOTM) This is a summary of results from 1 clinical study.
We thank all study participants. You helped us to answer important questions about linagliptin and empagliflozin and the treatment of Type 2 Diabetes.What was this study about?
The purpose of this study was to find out if a medicine called linagliptin or another medicine called empagliflozin lower blood sugar in children and adolescents with Type 2 Diabetes. Both medicines are already used to treat Type 2 Diabetes in adults.Who took part in this study?
Children and adolescents took part in the study. They could participate if they had Type 2 Diabetes. To be in the study, the participants had to have higher than normal blood sugar levels before the trial started.
157 children and adolescents were treated in the study. 97 participants were girls and 60 were boys. The youngest participant was 10 years old and the oldest was 17 years old. The average age of the participants was 15.
Participants in 12 countries were treated in this study.How was this study done?
The participants were divided into 3 groups of almost equal size. Every participant had an equal chance of being in each group. No one could choose which group a participant was placed in, because it was done by a computer. The groups were:
• Linagliptin group: participants took linagliptin
• Empagliflozin group: participants took empagliflozin
• Placebo group: participants took placebo
All participants took the study medicine once a day as a tablet. Placebo tablets looked like linagliptin or empagliflozin tablets but did not contain any medicine. Participants and doctors did not know which group the participants were in. Participants took the study medicines for half a year.
We wanted to find out whether either linagliptin or empagliflozin lowered participants’ blood sugar. We compared the blood sugar from participants in the linagliptin group and the empagliflozin group with blood sugar in the placebo group to find out whether either medication works to lower blood sugar.
After half a year, all participants took either linagliptin or empagliflozin for another 6 months. This means that participants in the placebo group switched to either linagliptin or empagliflozin treatment. Participants and doctors did not know which group the participants were in.
Participants visited the doctors regularly. During these visits, the doctors collected information about the participants’ health.What were the results of this study?
After taking the medicines for half a year, the group taking empagliflozin had lower blood sugar than the group taking placebo. The group taking linagliptin did not have any difference in blood sugar compared with the group taking placebo.Did participants have any unwanted effects?
Unwanted effects are health problems that the doctors think were caused by linagliptin, empagliflozin, or placebo.
Some participants in all 3 groups had unwanted effects. 9 out of 52 (17%) of the participants in the linagliptin group, 9 out of 52 (17%) of the participants in the empagliflozin group, and 6 out of 53 (11%) of the participants in the placebo group had unwanted effects.
The listing below shows the unwanted effects. The listing also shows how many participants had each of these unwanted effects.
Low blood sugar (hypoglycaemia):
• Linagliptin (52 participants): 5 participants (10%)
• Empagliflozin (52 participants): 4 participants (8%)
• Placebo (53 participants): 2 participants (4%)
Nausea:
• Linagliptin (52 participants): 2 participants (4%)
• Empagliflozin (52 participants): 1 participant (2%)
• Placebo (53 participants): 1 participant (2%)
Vaginal yeast infection (vulvovaginal mycotic infection):
• Linagliptin (52 participants): 2 participants (4%)
• Empagliflozin (52 participants): 0 participants
• Placebo (53 participants): 0 participants
Increase in blood ketones (Increased blood ketone body):
• Linagliptin (52 participants): 1 participant (2%)
• Empagliflozin (52 participants): 2 participants (4%)
• Placebo (53 participants): 0 participants
Fungal infection:
• Linagliptin (52 participants): 0 participants
• Empagliflozin (52 participants): 2 participants (4%)
• Placebo (53 participants): 0 participants
Some unwanted effects in this study were serious because they required a stay in hospital or a longer stay in hospital or were life-threatening. Unwanted effects were also serious if the doctor thought they were serious for any other reason. 1 of the children had a serious unwanted effect when they took placebo.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0171
Date of REC Opinion
8 Aug 2018
REC opinion
Further Information Favourable Opinion