Bariatric Surgery CandidatePhase 2NCT07515391
Dapagliflozin Effect on Glucose Variability in Patients Post Bariatric Surgery
A Phase 2 study testing Dapagliflozin 10 MG in people with Bariatric Surgery Candidate and Type2 Diabetes, run by Dasman Diabetes Institute at 1 site in Kuwait.
Trial 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 more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Bariatric Surgery Candidate, Type2 Diabetes
- What is being tested?
- Dapagliflozin 10 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteKuwait
- Study dates
- 22 Oct 2019to 22 Oct 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People diagnosed with type 2 diabetes prior to bariatric surgery.
- People did not have diabetes prior to bariatric surgery.
- Willing to participate in this study.
Who cannot join
- Type 1 diabetes
- Secondary diabetes
- History of ketoacidosis
- History of pancreatitis and pancreatectomy.
- History of primary renal glycosuria or hereditary glucose-galactose malabsorption.
- Active diabetes complications, nephropathy (dipstick positive proteinuria, or reduced eGFR (<60 ml/min), proliferative retinopathy.
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- Clinically significant abnormal liver function test.
- Pregnant ladies, or intending pregnancy or breastfeeding.
- Patients using insulin therapy or a sulfonylurea.
- Uncontrolled hypertension.
- Uncontrolled thyroid disease.
- Any history of serious hypertension reaction to the dapagliflozin or SGLT-2 inhibitor.
- History of malignancy within 5-year of screening.
- Presence of any other medical condition that would in the opinion of the investigator, preclude safe participation in the study.
- HbA1c >10.5
- Unable to sign the consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Bariatric Surgery Candidate, Type2 Diabetes
- Being tested
- Dapagliflozin 10 MG
- Keywords
- SGLT-2, Bariatric Surgery, Type 2 diabetes, Glucose variability
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 MGDrug
Dapagliflozin 10 mg drug will be administered in both arms for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| (1) People with type 2 diabetes with post-bariatric surgery | Active comparator | Not described Receives: Drug: Dapagliflozin 10 MG |
| (2) people without diabetes with post-bariatric surgery. | Active comparator | Not described Receives: Drug: Dapagliflozin 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (4)
Glucose variability, glycemic control (HbA1c)
Glucose variability, glycemic control (HbA1c)
Measured: 12 weeks
Glycemic control (HbA1c)
Glycemic control (HbA1c)
Measured: 12 weeks
change in body weight (Kg)
change in body weight (Kg)
Measured: 12 weeks
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start22 Oct 2019
- Primary completion1 May 2021
- Study completion22 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study has two groups (1) People with type 2 diabetes with post-bariatric surgery, (2) people without diabetes with post-bariatric surgery.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dasman Diabetes Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Kuwait Foundation for the Advancement of Sciences
- Responsible party
- Principal investigator, Dr. Ebaa Al Ozairi, Dasman Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515391
- Sponsor's protocol ID
- RA HM 2019-023
- Status last verified
- Mar 2026
- First submitted
- 11 Dec 2019
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No