Glycemic Control With Triple Pathway Approach Through Empagliflozin, Linagliptin and Metformin Combination
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNabiqasim Industries (Pvt) Ltd
About this trial
The efficacy and safety of a triple-pill combination therapy for advanced type 2 diabetes care. The study aims to assess the impact of 3 Oral Anti Diabetic (OAD) drugs on metabolic control, patient compliance, weight management, quality of life, diabetic treatment satisfaction and frequency of hypoglycemic events by combining them into a fixed-dose single pill.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients of any gender
Patients aged between 18-80 years
Patients having HbA1c 8 % or above
Patients diagnosed with type II diabetes (more than at least 06 months)
Disqualifiers
Patients with age less than 18
Patients with Type-I diabetes
Patients having diabetes for less than 06 months
Patients on GLP-1 and GIP
Trial design
Design model
Single group
Treatments tested in this trial
Empagliflozin+Linagliptin+Metformin
Combination productScarcity of local population data on triple drug combination's impact on compliance, efficacy and safety in diabetic patients
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: Glem-Lin MXR Single pill combination studyOther 1 intervention
Trial outcomes
Primary outcomes
1
Changes in HbA1c levels
Metabolic control
Time frame
03 months, 06 monthsSecondary outcomes
1
Change in scores of Quality of Life-Short Form "SF-36" questionnaire
Improvement in quality of life (before and after treatment)
Time frame
06 months2
Changes in Diabetic Treatment Satisfaction Questionnaire "DTSQ"
Diabetic treatment satisfaction level (before and after treatment)
Time frame
06 months3
Hypoglycemic events
Hypoglycemic events frequency and severity of hypoglycemic events
Time frame
06 months4
Changes in body weight
Increase or decrease in body weight
Time frame
03 and 06 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov