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The Potential of Dapagliflozin Plus Exenatide in Obese Insulin-resistant Patients
A 28-week, Multi-center Randomized, Double-blind, Placebo-controlled Study to Evaluate the Potential of Dapagliflozin Plus Exenatide in Combination With High-dose Intensive Insulin Therapy Compared to Placebo in Obese Insulin-resistant Patients With Type 2 Diabetes Mellitus (Proof-of-concept Study)
Lead sponsor
Asset
Exenatide
Subcutaneous · GLP-1 agonist
Listed sites
4
Recruiting sites
—
Enrollment
13
actual
Study population
Obesity / overweight, Type 2 diabetes
Key I/E criteria
•BMI ≥30•HbA1c 8-11%
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
For inclusion in the study patients should fulfill the following key criteria:
1. Informed Consent can be obtained prior to any study procedures.
2. Patient is able to read, understand and sign the Informed Consent.
3. HbA1c ≥ 8.0% and ≤ 11.0% based on laboratory results
4. Currently treated with a stable TDID ≥ 80 U at least 3 months prior to enrolment
5. Patients who are receiving metformin must be on a stable total daily dose ≥ 1500 mg or the maximum tolerated dose of metformin within 3 months prior to enrolment
6. BMI of ≥ 30 kg/m2 at enrolment
7. Male or female and ≥18 and ≤75 years old at time of informed consent
8. For female patients:
9. Patients who are receiving the following medications must be on a stable treatment regimen for a minimum of 2 months prior to Visit 0 (Screening):
Exclusion criteria
1. Diagnosis of Type 1 Diabetes
2. History of diabetic ketoacidosis, hyperosmolar coma or corticosteroid-induced Type 2 diabetes
3. Patients with significant thyroid disease
4. Patients with history of acute or chronic pancreatitis
5. Clinically significant cardiovascular disease or procedure within 3 months prior to enrolment or expected to require coronary revascularization procedure
6. Presence of history of severe congestive heart failure (NYHA III and IV)
7. Creatinin-Clearance of < 60 ml/min based on local laboratory results
8. Concomitant medication with loop diuretics
9. Patients who, as judged by the investigator, may be at risk for dehydration or volume depletion that may affect the patient's safety (including e.g. patients with a history of Diabetes insipidus)
10. Pregnant women
11. Administration of any other antidiabetic therapy, other than insulin (see inclusion criterion no.4 and 5) and metformin with a stable total daily dose ≥ 1500 mg or the maximum tolerated dose of metformin within 3 months prior to enrolment
12. History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥ 700 mg/dL (≥ 7.98 mmol/L) at Visit 0 (Screening).
13. History or presence of inflammatory bowel disease or other severe GI diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis.
14. History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded.
15. Significant hepatic disease, including, but not limited to, acute hepatitis, chronic active hepatitis, or severe hepatic insufficiency, including patients with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or total bilirubin (TB) >2 mg/dL (>34.2 μmol/L) (patients with TB >2 mg/dL [>34.2 μmol/L] and documented Gilbert's syndrome will be allowed to participate).
16. Known history of hepatotoxicity with any medication
17. Known history of severe hepatobiliary disease.
18. Positive serological test for hepatitis B or hepatitis C.
19. Known or suspected human immunodeficiency virus (HIV) infection.
20. History of organ transplantation.
21. Presence or history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN 2) OR a family history of medullary thyroid carcinoma or MEN 2.
22. Malignancy (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of Visit 0 (Screening).
23. Hemoglobinopathy, hemolytic anemia, or chronic anemia (haemoglobin concentration <11.5 g/dL [115 g/L] for males, <10.5 g/dL [105 g/L] for females) or any other condition known to interfere with the HbA1c methodology.
24. Patients with abnormal test results of hematocrit (hematocrit > 50% for men; hematocrit > 47% for women)
25. Has donated blood or had a significant blood loss within 2 months of first dose of study medication or is planning to donate blood during the study.
26. Has donated plasma within 7 days prior to first dose of study medication.
27. Any exposure to Exenatide (including BYETTA®, BYDUREON, or exenatide suspension).
28. Any exposure to Dapagliflozin or any SGLT-2 inhibitor.
29. Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:
Endpoints (7)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsChange in total body weight from baseline (week 0) to week 14 and 28
Time frame:28 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Change in BMI from baseline (week 0) to week 14 and 28
Time frame:28 weeks
BMI, change
change from baseline, improvement
Glycemic / diabetes
5 endpointsChange in HbA1c from baseline (week 0) to week 28
Time frame:28 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in HbA1c from baseline (week 0) to week 14
Time frame:14 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in FPG from baseline (week 0) to week 14 and 28
Time frame:28 weeks
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in TDID from baseline (week 0) to week 14 and 28
Time frame:28 weeks
change from baseline, improvement
Proportion of patients achieving HbA1c of ≤ 7% at week 28 compared to baseline
Time frame:28 weeks
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Publications (14)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- The lancet. Diabetes & endocrinology2016 Dec (month)PMID27651331doi:10.1016/S2213-8587(16)30267-4via CT.gov background
- Therapeutic advances in drug safety2014 Dec (month)PMID25436106doi:10.1177/2042098614551938via CT.gov background
- Diabetes, obesity & metabolism2014 Apr (month)PMID24251534doi:10.1111/dom.12237via CT.gov background
- Indian journal of endocrinology and metabolism2014 Mar (month)PMID24741511doi:10.4103/2230-8210.129106via CT.gov background
- American journal of preventive medicine2012 Jun (month)PMID22608371doi:10.1016/j.amepre.2011.10.026via CT.gov background
- Annals of internal medicine2012 Mar 20PMID22431673doi:10.7326/0003-4819-156-6-201203200-00003via CT.gov background
- The Journal of clinical endocrinology and metabolism2011 May (month)PMID21307137doi:10.1210/jc.2010-2081via CT.gov background
- Lancet (London, England)2010 Jun 26PMID20609969doi:10.1016/S0140-6736(10)60406-0via CT.gov background
- Journees annuelles de diabetologie de l'Hotel-Dieu2007 (year)PMID18613325via CT.gov background
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.