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Enrolling by invitationNCT07515391Updated Apr 7, 2026

Dapagliflozin Effect on Glucose Variability in Patients Post Bariatric Surgery

A Phase 2 interventional study of Dapagliflozin 10 MG in Bariatric Surgery Candidate and Type2 Diabetes, sponsored by Dasman Diabetes Institute. Enrolling by invitation at 1 site in Kuwait. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by Dasman Diabetes Institute · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study summary

This study evaluates the effect of SGLT-2 inhibitors (dapagliflozin) on the blood glucose excursions by a continuous glucose monitoring system, the incidence of hypoglycemia and hyperglycemia and change in glycated hemoglobin (HbA1c) level in people had bariatric surgery with and without type 2 diabetes.

Read the detailed description

Dapagliflozin is a highly selective sodium-glucose transporter 2 (SGLT2) inhibitor, an approved drug for the treatment of type 2 diabetes. It leads to urinary glucose excretion and a reduction of weight. This results in a reduction of both fasting and postprandial glucose levels. This is reported that the treatment of type 2 diabetes with dapagliflozin carries a low risk of hypoglycaemia and have a beneficial effect on weight and blood pressure.

This study hypothesized that bariatric surgery is effective for weight loss. But some patients experience large changes in the blood glucose after meals that lead to hyper and hypoglycaemia and weight regain. This study propose that the use of SGLT-2 inhibitors, which lower glucose and body weight by promoting its renal excretion, will reduce glucose variability in patients after bariatric surgery.

02

Conditions studied

  • Bariatric Surgery Candidate
  • Type2 Diabetes

Keywords

  • SGLT-2
  • Bariatric Surgery
  • Type 2 diabetes
  • Glucose variability
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 30 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Dasman Diabetes Institute is the lead sponsor of 31 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. People diagnosed with type 2 diabetes prior to bariatric surgery.
  2. People did not have diabetes prior to bariatric surgery.
  3. Willing to participate in this study.

Exclusion criteria

Exclusion Criteria:

  1. Type 1 diabetes
  2. Secondary diabetes
  3. History of ketoacidosis
  4. History of pancreatitis and pancreatectomy.
  5. History of primary renal glycosuria or hereditary glucose-galactose malabsorption.
  6. Active diabetes complications, nephropathy (dipstick positive proteinuria, or reduced (\<60 ml/min), proliferative retinopathy.
  7. abnormal liver function test.
  8. Pregnant ladies, or intending pregnancy or breastfeeding.
  9. Patients using insulin therapy or a sulfonylurea.
  10. Uncontrolled hypertension.
  11. Uncontrolled thyroid disease.
  12. Any history of serious hypertension reaction to the dapagliflozin or SGLT-2 inhibitor.
  13. History of within 5-year of screening.
  14. Presence of any other medical condition that would in the opinion of the investigator, preclude safe participation in the study.
  15. >10.5
  16. Unable to sign the consent form.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    (1) People with type 2 diabetes with post-bariatric surgery

    Drug: Dapagliflozin 10 MG

  • Active comparator
    (2) people without diabetes with post-bariatric surgery.

    Drug: Dapagliflozin 10 MG

Interventions

  • Dapagliflozin 10 mg drug will be administered in both arms for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Time spent below 3 mmol/L and above 10 mmol/L on and off dapagliflozin

    Time spent below 3 mmol/L and above 10 mmol/L on and off dapagliflozin

    Time frame: 12 weeks

Secondary outcomes

  1. Glucose variability, glycemic control (HbA1c)

    Glucose variability, glycemic control (HbA1c)

    Time frame: 12 weeks

  2. Glycemic control (HbA1c)

    Glycemic control (HbA1c)

    Time frame: 12 weeks

  3. change in body weight (Kg)

    change in body weight (Kg)

    Time frame: 12 weeks

  4. change in insulin resistance and beta cell function (HOMA-IR and HOMA-S)

    change in insulin resistance and beta cell function (HOMA-IR and HOMA-S)

    Time frame: 12 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07515391
Lead sponsor
Dasman Diabetes Institute
Collaborators
Kuwait Foundation for the Advancement of Sciences
Responsible party
Dr. Ebaa Al Ozairi (Chief Medical Officer, Dasman Diabetes Institute) — Principal investigator
First posted
Apr 7, 2026
Start date
Oct 22, 2019
Primary completion
May 1, 2021
Completion
Oct 22, 2026 (estimated)
Last update
Apr 7, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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