Comparison of efficacy of metformin plus dapagliflozin versus metformin plus insulin sensitizer in patients having diabetes mellitus type-2 in Pakistan.

Comparative assessment of anti-diabetic efficacy of metformin plus dapagliflozin with metformin plus insulin- sensitizer or secretagogues in patients with diabetes mellitus type-2 in Pakistan: A randomized trial.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622000243718

Acronym

CEMDI

Enrollment

Registered

2022-02-10

Start date

2022-04-01

Completion date

2022-04-30

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

It is hypothesized that combination of metformin with dapagliflozin is more effective than combination of metformin with insulin sensitizer in patient of type-2 diabetes mellitus. Therefore this study is aimed to assess and compare of efficacy of different combination of oral anti-diabetics in type-2 diabetes mellitus. For this purpose, a sample of around 84 patients shall be recruited and their baseline data shall be recorded. After baseline data collection is completed, the subjected shall be randomly allocated into two groups, Group A (The intervention group) and Group B (The active control or comparator). Sample size is calculated by Cochran formula. After group allocation, the intervention shall be administered for 3 months after which final data collection shall be made. Individual data of patient shall remain confidential. Data obtained shall be subjected to statistical analysis for reporting.

Interventions

Group A (Intervention group) will be given the combination of dapagliflozin plus metformin The detail of drug administration is as following: Group A: 1. Tablet Dapagliflozin 5mg-10mg, Once Daily, 3 months 2. Tablet Metformin 850-1000mg, Once Daily, 3 months The starting dose of drug for each patient shall be according to judgement of physician in correlation of clinical and laboratory values. The dose shall be increased, but not exceeding the maximum, as per recommendations made by physic

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

30 Years to 80 Years

Healthy volunteers

Inclusion criteria

1) Subject having Type-2 diabetes mellitus 2) Both Male & Female 3) Patients having glycated hemoglobin ranging between 6.5 to 12.5% 4) Age from 30 to 80 year 5) BMI greater than 23 kg/m^2 6) Patients who can understand and give consent for study

Exclusion criteria

1) Patients not using any oral anti diabetic combination from previous 4 weeks. 2) Subject having type 1 diabetes mellitus. 3) Person with history of blood pressure greater than 180 mm of Hg 4) Pregnancy 5) Patients with renal insufficiency 6) Lactating females 7) Dementia

Outcome results